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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Overweight and Obesity

Treatments: Drug: NNC0174 0833

Study type: Interventional

Funder types: Industry

Identifiers

NCT05254158

U1111-1247-7538 (Other Identifier)

NN9838-4615

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups

NNC0174 0833 1.8 mg

Experimental group

Description:

Each participant will receive one single dose of NNC0174 0833

Treatment:

Drug: NNC0174 0833

NNC0174 0833 0.9 mg

Experimental group

Description:

Each participant will receive one single dose of NNC0174 0833

Treatment:

Drug: NNC0174 0833

NNC0174 0833 0.3 mg

Experimental group

Description:

Each participant will receive one single dose of NNC0174 0833

Treatment:

Drug: NNC0174 0833