A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity

NCT05254158 | Completed Phase 1

• 2 other identifiers: NN9838-4615U1111-1247-7538
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to look at how the study medicine behaves in participants body and how it is removed from their body. The study compares three different doses of the study medicine in Chinese healthy men. Participant will either get 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833 which dose participant get is decided by chance. NNC0174-0833 is a new medicine and has not been approved by the Center for Drug Evaluation. We are testing the study medicine to make a medicine that can help people lose weight. Participant will get 1 injection by a study nurse or doctor at the clinic. The injection will be with a needle in a skin fold in the stomach area. The study will last for about 5 months. But participants participation will last about 2 months. Participant will have 8 clinic visits with the study staff. One of these visits will be a 7-day, 6-night stay. At all visits, except the information visit, participant will have blood drawn along with other clinical examinations. Participants will be asked about their health, medical history and habits including mental health.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• AUC0-∞, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after a single dose

  measured in h·nmol/L

  From pre-dose (Day 1) to Visit 7 (Day 36)

Secondary Outcomes (7)

• AUC0-168, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to 168 hours after a single dose

  From pre-dose (Day 1) to Visit 3 (Day 8)

• Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma

  From pre-dose (Day 1) to Visit 7 (Day 36)

• tmax, NNC0174-0833: The time from dose administration to maximum plasma concentration of NNC0174-0833

  From pre-dose (Day 1) to Visit 7 (Day 36)

• t1/2, NNC0174-0833: The terminal half-life of NNC0174-0833

  From pre-dose (Day 1) to Visit 7 (Day 36)

• CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833

  From pre-dose (Day 1) to Visit 7 (Day 36)

Study Arms (3)

NNC0174 0833 1.8 mg

EXPERIMENTAL

Each participant will receive one single dose of NNC0174 0833

Drug: NNC0174 0833

NNC0174 0833 0.9 mg

EXPERIMENTAL

Each participant will receive one single dose of NNC0174 0833

Drug: NNC0174 0833

NNC0174 0833 0.3 mg

EXPERIMENTAL

Each participant will receive one single dose of NNC0174 0833

Drug: NNC0174 0833

Interventions

NNC0174 0833 DRUG

Participants will either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, administered subcutaneously (s.c., under the skin)

NNC0174 0833 0.3 mg; NNC0174 0833 0.9 mg; NNC0174 0833 1.8 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese male subject aged 18-55 years (both inclusive) at the time of signing informed consent.
• Body mass index (BMI) between 20.0 and 39.9 kg/m\^2 (both inclusive) at screening.
• Body weight between 60.0 and 110.0 kg (both inclusive) at screening.

You may not qualify if:

• Male subject who is not sexually abstinent or surgically sterilised (vasectomy) or who or whose partner(s) is not willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').
• Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Transparency (dept. 1452)

  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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: March 3, 2022
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)