## Protocol Section
### Identification Module
**NCT ID:** NCT01909479

**Brief Title:** A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency

**Official Title:** A Phase 3, Multicenter Study Designed To Evaluate The Efficacy And Safety Of A Long Acting hGH Product (MOD-4023) In Adult Subjects With Growth Hormone Deficiency

#### Organization Study ID Info
**ID:** CP-4-005
#### Organization
**Class:** INDUSTRY
**Full Name:** OPKO Health, Inc.
#### Secondary ID Infos
**ID:** 2013-000830-37
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2018-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-12

**Type:** ACTUAL

**Last Update Submit Date:** 2022-08-11

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2016-08

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2022-08-12

**Type:** ACTUAL

**Results First Submit Date:** 2021-12-15

**Results First Submit QC Date:** 2022-08-11

#### Start Date
**Date:** 2013-06

**Status Verified Date:** 2022-08

#### Study First Post Date
**Date:** 2013-07-26
**Type:** ESTIMATED
**Study First Submit Date:** 2013-07-24
**Study First Submit QC Date:** 2013-07-25
**Why Stopped:** Main Study was completed. LT-OLE was discontinued as sufficient safety data has been generated.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** OPKO Health, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023).

### Conditions Module

**Conditions:**

- Adult Growth Hormone Deficiency

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 202

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: MOD-4023

**Label:** MOD-4023

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MOD-4023

**Description:** Individualized once weekly dose of MOD-4023

**Name:** MOD-4023

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Once weekly administration of placebo

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26

**Time Frame:** Baseline to 26 weeks

#### Secondary Outcomes

**Measure:** Change in Total Fat Mass, Expressed in Kilograms, Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26

**Time Frame:** Baseline to 26 weeks

**Measure:** Change in Lean Body Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26

**Time Frame:** Baseline to 26 weeks

**Measure:** Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to 52 Weeks

**Time Frame:** Baseline to 52 weeks

**Measure:** Change in Trunk Fat Mass, Expressed as % Change From Baseline, Measured With Dual-energy X-ray Absorptiometry, From Baseline to 26 and 52 Weeks

**Time Frame:** 26 weeks to 52 weeks

**Measure:** Trunk Fat Mass as Percentage of Total Fat Mass From Baseline to Week 26

**Time Frame:** Baseline to 26 weeks

**Measure:** Change in Biochemical Marker IGF-1

**Time Frame:** Baseline to 26 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Men and women between the age of 23 to 70 years old at screening, inclusive
* GHD subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007).
* No r-hGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational r-hGH or GH secretagogue product.
* The IGF-I level at screening ≤-1 SDS of the age and sex normal ranges according to the central laboratory measurements
* Subjects who are on a stable diet and exercise regime and do not have plans to modify their diet or exercise for at least 12 months
* Subject had a DXA screening and the results are interpretable according to the study plan.

Exclusion Criteria:

* Women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation)
* Evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous MRI to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth).
* History of any cancer. Exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. Patients with GHD attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record.
* Signs of intracranial hypertension at screening
* Heart insufficiency, NYHA class \> 2 (Appendix B)
* History of overt diabetes mellitus (including currently treated, well-controlled DM) defined according to the American Diabetes Association (ADA) Criteriaa. A history of gestational diabetes, resolved after childbirth, is not exclusionary.
* History of Acromegaly

**Maximum Age:** 70 Years

**Minimum Age:** 23 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kiryat Gat

**Country:** Israel

**Facility:** Opko Biologics

**Zip:** 8211804

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004392

- Term: Dwarfism

- ID: D000001848

- Term: Bone Diseases, Developmental

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000001849

- Term: Bone Diseases, Endocrine

- ID: D000007018

- Term: Hypopituitarism

- ID: D000010900

- Term: Pituitary Diseases

- ID: D000007027

- Term: Hypothalamic Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7566

- Name: Dwarfism

- Relevance: LOW

- As Found: Unknown

- ID: M13791

- Name: Pituitary Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7567

- Name: Dwarfism, Pituitary

- Relevance: HIGH

- As Found: Growth Hormone Deficiency

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: HIGH

- As Found: Hormone Deficiency

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5127

- Name: Bone Diseases, Developmental

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5128

- Name: Bone Diseases, Endocrine

- Relevance: LOW

- As Found: Unknown

- ID: M10068

- Name: Hypopituitarism

- Relevance: LOW

- As Found: Unknown

- ID: M10077

- Name: Hypothalamic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2633

- Name: Growth Hormone Deficiency

- Relevance: HIGH

- As Found: Growth Hormone Deficiency

- ID: T3125

- Name: Isolated Growth Hormone Deficiency

- Relevance: HIGH

- As Found: Growth Hormone Deficiency

- ID: T2955

- Name: Hypopituitarism

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004393

- Term: Dwarfism, Pituitary

- ID: D000004700

- Term: Endocrine System Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

#### Removed Countries

- Country: United States

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study

#### Event Groups

**Group ID:** EG000

**Title:** MOD-4023 Period 1

**Deaths Num At Risk:** 133

**Description:** MOD-4023: Individualized once weekly dose of MOD-4023 (Period 1)

**ID:** EG000

**Other Num Affected:** 36

**Other Num at Risk:** 133

**Serious Number Affected:** 4

**Serious Number At Risk:** 133

**Title:** MOD-4023 Period 1

**Group ID:** EG001

**Title:** Placebo Period 1

**Deaths Num At Risk:** 65

**Description:** Placebo: Once weekly administration of placebo (Period 1. Only till week 26). Open label once weekly dose of MOD-4023 thereafter

**ID:** EG001

**Other Num Affected:** 27

**Other Num at Risk:** 65

**Serious Number Affected:** 5

**Serious Number At Risk:** 65

**Title:** Placebo Period 1

**Group ID:** EG002

**Title:** MOD-4023 Period 2 (Treatment Assignments at Period 1)

**Deaths Num At Risk:** 133

**Description:** MOD-4023: Individualized once weekly dose of MOD-4023 (Period 2)

**ID:** EG002

**Other Num Affected:** 28

**Other Num at Risk:** 133

**Serious Number Affected:** 5

**Serious Number At Risk:** 133

**Title:** MOD-4023 Period 2 (Treatment Assignments at Period 1)

**Group ID:** EG003

**Title:** Placebo Period 2 (Treatment Assignments at Period 1)

**Deaths Num At Risk:** 65

**Description:** Placebo assigned and treated in Period 1. Open-label MOD-4023 treatment in Periods 2 and 3

**ID:** EG003

**Other Num Affected:** 16

**Other Num at Risk:** 65

**Serious Number Affected:** 3

**Serious Number At Risk:** 65

**Title:** Placebo Period 2 (Treatment Assignments at Period 1)

**Group ID:** EG004

**Title:** MOD-4023 Period 3 (Treatment Assignments at Period 1)

**Deaths Num At Risk:** 111

**Description:** MOD-4023: Individualized once weekly dose of MOD-4023 (Period 3).

Period 3 was a long-term open label extension

**ID:** EG004

**Other Num Affected:** 46

**Other Num at Risk:** 111

**Serious Number Affected:** 10

**Serious Number At Risk:** 111

**Title:** MOD-4023 Period 3 (Treatment Assignments at Period 1)

**Group ID:** EG005

**Title:** Placebo Period 3 (Treatment Assignments at Period 1)

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 50

**Description:** Placebo assigned and treated in Period 1. Open-label MOD-4023 treatment in Periods 2 and 3

**ID:** EG005

**Other Num Affected:** 30

**Other Num at Risk:** 50

**Serious Number Affected:** 8

**Serious Number At Risk:** 50

**Title:** Placebo Period 3 (Treatment Assignments at Period 1)

**Frequency Threshold:** 5

#### Other Events

**Term:** Injection site pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Sinusitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Paraesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Acute Myocardial Infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Atrial Fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Abdominal Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Duodenal Ulcer Haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Gastric Disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Diverticulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Urinary Tract Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Pain In Extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Synovitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Inguinal hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Cholecystitis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Gastroenteritis viral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Respiratory tract infection viral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Upper limb fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Appendicitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Colonic abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Pyelonephritis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Angina pectoris

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Adrenal insufficiency

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Pituitary-dependent Cushing's syndrom

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Joint injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Pneumothorax traumatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Rib fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Lumbar spinal stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Haemangioma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Squamous cell carcinoma of lung

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Hemianopia heteronymous

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Spinal claudication

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Enterocolitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num At Risk:** 111

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Device loosening

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Product Issues

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Term:** Pneumonia aspiration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 133

**Group ID:** EG001

**Num At Risk:** 65

**Group ID:** EG002

**Num At Risk:** 133

**Group ID:** EG003

**Num At Risk:** 65

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 111

**Group ID:** EG005

**Num At Risk:** 50

**Time Frame:** These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 133

**Group ID:** BG001

**Value:** 65

**Group ID:** BG002

**Value:** 198

**Units:** Participants

### Group

**ID:** BG000

**Title:** MOD-4023

**Description:** MOD-4023: Individualized once weekly dose of MOD-4023

### Group

**ID:** BG001

**Title:** Placebo

**Description:** Placebo: Once weekly administration of placebo

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.6

**Value:** 43.9

#### Measurement

**Group ID:** BG001

**Spread:** 12.9

**Value:** 43.1

#### Measurement

**Group ID:** BG002

**Spread:** 12.6

**Value:** 43.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 57

#### Measurement

**Group ID:** BG001

**Value:** 25

#### Measurement

**Group ID:** BG002

**Value:** 82

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 76

#### Measurement

**Group ID:** BG001

**Value:** 40

#### Measurement

**Group ID:** BG002

**Value:** 116

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 110

#### Measurement

**Group ID:** BG001

**Value:** 53

#### Measurement

**Group ID:** BG002

**Value:** 163

**Class Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 3

**Class Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 23

**Class Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

**Class Title:** Other

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 7

**Class Title:** Not Reported

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 31

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 46

**Class Title:** United States

#### Measurement

**Group ID:** BG000

**Value:** 88

#### Measurement

**Group ID:** BG001

**Value:** 43

#### Measurement

**Group ID:** BG002

**Value:** 131

**Class Title:** Europe

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 21

**Class Title:** East Asia

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 15.0

**Value:** 75.2

#### Measurement

**Group ID:** BG001

**Spread:** 17.9

**Value:** 77.8

#### Measurement

**Group ID:** BG002

**Spread:** 15.0

**Value:** 75.2

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 3.2

**Value:** 27.0

#### Measurement

**Group ID:** BG001

**Spread:** 3.5

**Value:** 27.7

#### Measurement

**Group ID:** BG002

**Spread:** 3.2

**Value:** 27.0

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Year
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Weight
**Unit of Measure:** Kilogram
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** BMI
**Unit of Measure:** Kilogram/meter^2
**Population Description:** 202 subjects met the study's eligibility criteria and were randomized to either MOD-4023 or placebo. Only 198 subjects actually treated and included in the efficacy analysis.
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Point of Contact
**Email:** contact@opko.com
**Organization:** OPKO Health Inc
**Phone:** 3055754100
**Title:** OPKO Health Inc
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.2
- **Upper Limit:** 
- **Value:** -0.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** 0.1
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.21
- **Upper Limit:** 
- **Value:** -0.18
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.64
- **Upper Limit:** 
- **Value:** 0.00
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.4
- **Upper Limit:** 
- **Value:** 1.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** 0.0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** -0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.1
- **Upper Limit:** 
- **Value:** -0.3
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.5
- **Upper Limit:** 
- **Value:** -2.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 10.0
- **Upper Limit:** 
- **Value:** 0.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 125
- **Group ID:** OG001
- **Value:** 56
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.1
- **Upper Limit:** 
- **Value:** -1.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.8
- **Upper Limit:** 
- **Value:** -1.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 125
- **Group ID:** OG001
- **Value:** 55
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.0
- **Upper Limit:** 
- **Value:** -1.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.7
- **Upper Limit:** 
- **Value:** 0.6
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 42.4
- **Upper Limit:** 
- **Value:** 134.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 29.2
- **Upper Limit:** 
- **Value:** 54.5
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 198 of the 202 randomized subjects received treatment
**Reporting Status:** POSTED
**Time Frame:** Baseline to 26 weeks
**Title:** Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
**Type:** PRIMARY
**Unit of Measure:** kg
##### Group
**Description:** MOD-4023: Individualized once weekly dose of MOD-4023
**ID:** OG000
**Title:** MOD-4023
##### Group
**Description:** Placebo: Once weekly administration of placebo
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 3 subjects discontinued MOD-4023 due to consent withdrawn or lost to follow-up. 2 subjects discontinued placebo due to consent withdrawn or adverse event.
**Reporting Status:** POSTED
**Time Frame:** Baseline to 26 weeks
**Title:** Change in Total Fat Mass, Expressed in Kilograms, Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
**Type:** SECONDARY
**Unit of Measure:** kg
##### Group
**Description:** MOD-4023: Individualized once weekly dose of MOD-4023
**ID:** OG000
**Title:** MOD-4023
##### Group
**Description:** Placebo: Once weekly administration of placebo
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 3 subjects discontinued MOD-4023 due to consent withdrawn or lost to follow-up. 2 subjects discontinued placebo due to consent withdrawn or adverse event.
**Reporting Status:** POSTED
**Time Frame:** Baseline to 26 weeks
**Title:** Change in Lean Body Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
**Type:** SECONDARY
**Unit of Measure:** kg
##### Group
**Description:** MOD-4023: Individualized once weekly dose of MOD-4023
**ID:** OG000
**Title:** MOD-4023
##### Group
**Description:** Placebo: Once weekly administration of placebo
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline to 52 weeks
**Title:** Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to 52 Weeks
**Type:** SECONDARY
**Unit of Measure:** kg
##### Group
**Description:** MOD-4023: Individualized once weekly dose of MOD-4023
**ID:** OG000
**Title:** MOD-4023
##### Group
**Description:** Placebo: Once weekly administration of placebo
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 5
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 3 subjects discontinued MOD-4023 due to consent withdrawn or lost to follow-up. 2 subjects discontinued placebo due to consent withdrawn or adverse event.
**Reporting Status:** POSTED
**Time Frame:** 26 weeks to 52 weeks
**Title:** Change in Trunk Fat Mass, Expressed as % Change From Baseline, Measured With Dual-energy X-ray Absorptiometry, From Baseline to 26 and 52 Weeks
**Type:** SECONDARY
**Unit of Measure:** percentage of change from baseline
##### Group
**Description:** MOD-4023: Individualized once weekly dose of MOD-4023
**ID:** OG000
**Title:** MOD-4023
##### Group
**Description:** Placebo: Once weekly administration of placebo
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 6
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline to 26 weeks
**Title:** Trunk Fat Mass as Percentage of Total Fat Mass From Baseline to Week 26
**Type:** SECONDARY
**Unit of Measure:** percentage of change from baseline
##### Group
**Description:** MOD-4023: Individualized once weekly dose of MOD-4023
**ID:** OG000
**Title:** MOD-4023
##### Group
**Description:** Placebo: Once weekly administration of placebo
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 7
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline to 26 weeks
**Title:** Change in Biochemical Marker IGF-1
**Type:** SECONDARY
**Unit of Measure:** ug/L
##### Group
**Description:** MOD-4023: Individualized once weekly dose of MOD-4023
**ID:** OG000
**Title:** MOD-4023
##### Group
**Description:** Placebo: Once weekly administration of placebo
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** MOD-4023: Individualized once weekly dose of MOD-4023
**ID:** FG000
**Title:** MOD-4023
#### Group
**Description:** Placebo: Once weekly administration of placebo
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** From Baseline to Week 26
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
##### Withdraw
**Type:** Site and study closed by PI
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 135
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 67
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 129
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 58
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 9
#### Period
**Title:** 26 - 52 Weeks
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
**Comment:** One patient withdrew consent after completing Period 1
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 128
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 58
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 125
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 56
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
#### Period
**Title:** 52 Weeks to End of Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 18
###### Reason
**Group ID:** FG001
**Number of Subjects:** 8
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Progressive disease
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Personal reasons
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Sponsor's decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Study termination by sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Lack of contact
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Occurrence of malignancy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Diabetes not controlled
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 111
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 50
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 83
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 35
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 28
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 15
**Has Results:** True