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

Overweight and Obesity Clinical Trial

Official title:

Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0174-0833 in Chinese Male Subjects Being Normal Weight, Overweight or With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05254158
• Other study ID #: NN9838-4615
• Secondary ID: U1111-1247-7538
• Status: Completed
• Phase: Phase 1
• Start date: March 3, 2022
• Est. completion date: September 7, 2022

Study information

• Verified date: November 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 7, 2022
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Key inclusion criteria

• 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.

Key exclusion criteria

• 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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Drug:
• NNC0174 0833
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)

Locations

Country	Name	City	State
China	Novo Nordisk Investigational Site	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-8, 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	AUC0-168, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to 168 hours after a single dose	measured in h·nmol/L	From pre-dose (Day 1) to Visit 3 (Day 8)
Secondary	Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma	measured in nmol/L	From pre-dose (Day 1) to Visit 7 (Day 36)
Secondary	tmax, NNC0174-0833: The time from dose administration to maximum plasma concentration of NNC0174-0833	measured in hours	From pre-dose (Day 1) to Visit 7 (Day 36)
Secondary	t1/2, NNC0174-0833: The terminal half-life of NNC0174-0833	measured in hours	From pre-dose (Day 1) to Visit 7 (Day 36)
Secondary	CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833	measured in L/h	From pre-dose (Day 1) to Visit 7 (Day 36)
Secondary	Vz/FNNC0174-0833: The apparent volume of distribution of NNC0174-0833 in the terminal phase	measured in L	From pre-dose (Day 1) to Visit 7 (Day 36)
Secondary	Change in body weight	measured in percentage	From pre-dose (Day 1) to Visit 7 (Day 36)