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

Phase 1

Completed

• Conditions: Overweight and Obesity
• Interventions: Drug: NNC0174 0833

• Registration Number: NCT05254158
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-24
• Study Start: 2022-03-03
• Primary Completion: 2022-09-07
• Study Completion: 2022-09-07
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NNC0174 0833 0.9 mg	NNC0174 0833	Each participant will receive one single dose of NNC0174 0833
NNC0174 0833 0.3 mg	NNC0174 0833	Each participant will receive one single dose of NNC0174 0833
NNC0174 0833 1.8 mg	NNC0174 0833	Each participant will receive one single dose of NNC0174 0833

Primary Outcome Measures

Name	Time	Method
AUC0-∞, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after a single dose	From pre-dose (Day 1) to Visit 7 (Day 36)	measured in h·nmol/L

Secondary Outcome Measures

Name	Time	Method
Change in body weight	From pre-dose (Day 1) to Visit 7 (Day 36)	measured in percentage
CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833	From pre-dose (Day 1) to Visit 7 (Day 36)	measured in L/h
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)	measured in h·nmol/L
t1/2, NNC0174-0833: The terminal half-life of NNC0174-0833	From pre-dose (Day 1) to Visit 7 (Day 36)	measured in hours
Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma	From pre-dose (Day 1) to Visit 7 (Day 36)	measured in nmol/L
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)	measured in hours
Vz/FNNC0174-0833: The apparent volume of distribution of NNC0174-0833 in the terminal phase	From pre-dose (Day 1) to Visit 7 (Day 36)	measured in L

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇳 Shanghai, Shanghai, China