A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity

NCT06049329 | Completed Phase 1

• 2 other identifiers: NN9487-5022U1111-1284-5901
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as an oral tablet to Japanese participants.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAE)

  Number of events

  From pre-dose on Day 1 until completion of the end of study visit Day 31

Secondary Outcomes (3)

• AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose

  From pre-dose on Day 10 until Day 11 (24 hours post-dose)

• Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose

  From pre-dose on Day 10 until completion of the end of study visit Day 31

• tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose

  From pre-dose on Day 10 until completion of the end of study visit Day 31

Study Arms (2)

NNC0487-0111

EXPERIMENTAL

Once-daily oral administration - 1 of 3 different doses

Drug: NNC0487-0111

Placebo

PLACEBO COMPARATOR

Once-daily oral administration - 1 of 3 different doses

Drug: Placebo (NNC0487-0111)

Interventions

NNC0487-0111 DRUG

Participants will get one tablet to swallow at the same time of the day.

NNC0487-0111

Placebo (NNC0487-0111) DRUG

Participants will get one tablet to swallow at the same time of the day.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male with both parents of Japanese descent
• Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive). Body weight equal to or greater than 65.0 kg
• Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

You may not qualify if:

• Any disorder that in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
• Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Hakata Clinic

Fukuoka, 812-0025, Japan

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 22, 2023
• Study Start: September 14, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)