## Protocol Section
### Identification Module
**NCT ID:** NCT06174779

**Brief Title:** A Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus

**Official Title:** A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus

#### Organization Study ID Info
**ID:** HM-EXC-301
#### Organization
**Class:** INDUSTRY
**Full Name:** Hanmi Pharmaceutical Company Limited
### Status Module
#### Completion Date
**Date:** 2026-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-18

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-08

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-19

**Type:** ESTIMATED

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2023-12-18
**Type:** ACTUAL
**Study First Submit Date:** 2023-12-08
**Study First Submit QC Date:** 2023-12-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hanmi Pharmaceutical Company Limited

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in adult obesity patients without diabetes mellitus

### Conditions Module

**Conditions:**

- Obesity

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 420

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Weekly administration by subcutaneous injection

**Intervention Names:**

- Drug: HM11260C

**Label:** HM11260C

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Weekly administration by subcutaneous injection

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HM11260C

**Description:** Test drug

**Name:** HM11260C

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo drug

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** The percent change of body weight from baseline

**Time Frame:** baseline, 40 weeks

**Measure:** The proportion of subjects achieving body weight loss ≥ 5% from baseline

**Time Frame:** baseline, 40 weeks

#### Secondary Outcomes

**Measure:** The percent change of body weight from baseline

**Time Frame:** baseline, 24 weeks, 64 weeks

**Measure:** The proportion of subjects achieving body weight loss ≥ 5% from baseline

**Time Frame:** baseline, 24 weeks, 64 weeks

**Measure:** The proportion of subjects achieving body weight loss ≥ 10% from baseline

**Time Frame:** baseline, 24 weeks, 40 weeks, 64 weeks

**Measure:** Change of body weight from baseline

**Time Frame:** baseline, 24 weeks, 40 weeks, 64 weeks

**Measure:** Change of BMI from baseline

**Time Frame:** baseline, 24 weeks, 40 weeks, 64 weeks

**Measure:** Change of waist circumference from baseline

**Time Frame:** baseline, 24 weeks, 40 weeks, 64 weeks

**Measure:** Change of glucose metabolism parameters from baseline

**Time Frame:** baseline, 24 weeks, 40 weeks, 64 weeks

**Measure:** The percentage change of lipid profile parameters from baseline

**Time Frame:** baseline, 24 weeks, 40 weeks, 64 weeks

**Measure:** Change of blood pressure from baseline

**Time Frame:** baseline, 24 weeks, 40 weeks, 64 weeks

**Measure:** Change of IWQoL-Lite-CT(Physical function domain) from baseline

**Time Frame:** baseline, 24 weeks, 40 weeks, 64 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patients with following criteria :

   * BMI ≥ 30 kg/m2 or
   * 27 kg/m2 ≤ BMI \< 30 kg/m2 with more than one risk factors or comorbidities(hypertension, dyslipidemia, sleep apnea, cardiocerebrovascular disease)
2. A person who have failed at least once to weight control using diet and exercise therapy before screening visit.

Exclusion Criteria:

1. A person whose weight change exceeds 5kg within 3 months prior to screening visit.
2. Diabetes mellitus (Type 1, type 2, etc.) or HbA1c ≥ 6.5 %.
3. Administration of hypoglycemic agents.
4. Administration of medicines inducing weight gain.
5. Prader-Willi Syndrome or MC4R deficiency.
6. Cushing's Syndrome.
7. Administration of medicines for weight management.
8. A person who has a history of surgery(including device-based therapy) related to obesity or who has a plan during the clinical trial period.
9. Administration of Steroids for the systemic use.
10. Clinically significant gastric emptying abnormalities.
11. History(including family history) of medullary thyroid carcinoma or multiple endocrine adenomatosis.
12. History of acute or chronic pancreatitis.
13. A person who has the following clinical laboratory test results :

    * TSH \< 0.4 mIU/L or TSH \> 6 mIU/L
    * Calcitonin \> 100 ng/L
    * Amylase or Lipase \> 3 x UNL
14. Severe liver disease (AST or AST \> 3 x UNL or Total bilirubin \> 1.5 x UNL).
15. Severe renal disease ( eGFR \< 30mL/min/1.73m 2 ).
16. QTc \> 450 ms.
17. Answered 'yes' to question 4 or 5 of the suicidal ideation domain in C-SSRS or history of suicide attempt.
18. PHQ-9 ≥ 15 or history of depression, anxiety, and other severe Mental illness.
19. History of alcohol addiction or drug abuse.
20. History of malignant tumors.
21. History of severe heart disease or severe neurovascular disease.
22. Hypersensitivity to investigational products or multi-drug allergy.
23. Positive to pregnancy test, nursing mother, intention on pregnancy.
24. Considered by investigator as not appropriate to participate in the clinical study with other reason.

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** skyko7@hanmi.co.kr

**Name:** Na Young Kim

**Phone:** 82-2-410-9165

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obesity

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009765

- Term: Obesity

- ID: D000003920

- Term: Diabetes Mellitus

### Misc Info Module

- Version Holder: 2024-05-24
