## Protocol Section
### Identification Module
**NCT ID:** NCT02146079

**Brief Title:** A Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects

**Official Title:** A Single-centre, Parallel-group, Randomised, Double-blind, Placebocontrolled, Multiple-dose Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects

#### Organization Study ID Info
**ID:** NN9535-3634
#### Organization
**Class:** INDUSTRY
**Full Name:** Novo Nordisk A/S
#### Secondary ID Infos
**Domain:** WHO
**ID:** U1111-1147-6660
**Type:** OTHER
**Domain:** JAPIC
**ID:** JapicCTI-142550
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2014-10-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-04-18

**Type:** ACTUAL

**Last Update Submit Date:** 2018-04-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-10-20

**Type:** ACTUAL

#### Start Date
**Date:** 2014-05-21

**Type:** ACTUAL

**Status Verified Date:** 2018-04

#### Study First Post Date
**Date:** 2014-05-23
**Type:** ESTIMATED
**Study First Submit Date:** 2014-05-21
**Study First Submit QC Date:** 2014-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novo Nordisk A/S

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), and the safety and tolerability of semaglutide in healthy male Japanese and Caucasian subjects.

### Conditions Module

**Conditions:**

- Diabetes

- Diabetes Mellitus, Type 2

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 44

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Dose-escalation trial

**Intervention Names:**

- Drug: semaglutide

**Label:** Semaglutide 0.5 mg

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: placebo

**Label:** Semaglutide placebo 0.5 mg

**Type:** PLACEBO_COMPARATOR

#### Arm Group 3

**Description:** Dose-escalation trial

**Intervention Names:**

- Drug: semaglutide

**Label:** Semaglutide 1.0 mg

**Type:** EXPERIMENTAL

#### Arm Group 4

**Intervention Names:**

- Drug: placebo

**Label:** Semaglutide placebo 1.0 mg

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Semaglutide 0.5 mg

- Semaglutide 1.0 mg

**Description:** Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule

**Name:** semaglutide

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Semaglutide placebo 0.5 mg

- Semaglutide placebo 1.0 mg

**Description:** Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule.

**Name:** placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Area under the plasma semaglutide concentration-time curve

**Time Frame:** During a dosing interval (0-168 hours) at steady state

#### Secondary Outcomes

**Measure:** Maximum observed plasma semaglutide concentration at steady state

**Time Frame:** 0-168 hours after the last dose of semaglutide (0.5 and 1.0 mg)

**Measure:** Change in body weight from baseline to the end of treatment

**Time Frame:** Day 1 of Visit 2 (2-21 days after Visit 1), Day 92

**Measure:** Number of treatment emergent adverse events (TEAEs) from baseline to follow-up

**Time Frame:** From Day 1 of Visit 2 (2-21 days after Visit 1) to Day 120-127 (Visit 23)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy male Japanese and Caucasian subjects
* Age between 20 and 55 years (both inclusive) at the time of signing informed consent
* Body weight of equal to or above 54.0 kg
* Body mass index (BMI) between 20.0 and 25.0 kg/m\^2 (both inclusive)
* Glycosylated haemoglobin A1c (HbA1c) below or equal to 6.0%
* For Japanese subjects only: both parents Japanese
* For Caucasian subjects only: both parents Caucasian

Exclusion Criteria:

* Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiological, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN2)
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Calcitonin above or equal to 50 ng/L
* History of alcohol abuse within 1 year from screening, or a positive result in the alcohol breath test, or consumption of more than 21 units of alcohol weekly: 1 unit of alcohol equals approximately 250 mL of beer or lager, or approximately120 mL (one glass) of wine or Japanese sake, or approximately 20 mL of spirits
* Smoking of more than 5 cigarettes (including nicotine substitute products) or the equivalent, per day or unwilling to refrain from smoking whenever required for the trial procedure
* Use of prescription drugs within 3 weeks or 5 times the half-life, whichever is longer, prior to Visit 2 (randomisation), non-prescription drugs within 1 week prior to Visit 2 (randomisation). The use of vitamins, minerals and nutritional supplements, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 20 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tokyo

**Country:** Japan

**Facility:** Novo Nordisk Investigational Site

**Zip:** 130-0004

#### Overall Officials

**Official 1:**

**Affiliation:** Novo Nordisk A/S

**Name:** Global Clinical Registry (GCR, 1452)

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Ikushima I, Jensen L, Flint A, Nishida T, Zacho J, Irie S. A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects. Adv Ther. 2018 Apr;35(4):531-544. doi: 10.1007/s12325-018-0677-1. Epub 2018 Mar 13.

**PMID:** 29536338

#### See Also Links

**Label:** Clinical Trials at Novo Nordisk

**URL:** http://novonordisk-trials.com

## Derived Section

### Condition Browse Module - Ancestors

- 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

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 2

- 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: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Intervention Browse Module - Ancestors

- ID: D000097789

- Term: Glucagon-Like Peptide-1 Receptor Agonists

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M353561

- Name: Semaglutide

- Relevance: HIGH

- As Found: Physical therapy

- ID: M9043

- Name: Glucagon

- Relevance: LOW

- As Found: Unknown

- ID: M3401

- Name: Glucagon-Like Peptide-1 Receptor Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M26997

- Name: Glucagon-Like Peptide 1

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000591245

- Term: Semaglutide

### Misc Info Module

- Version Holder: 2024-05-24
