Overview
A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2022-05-14
2022-05-14
Target enrollment:
0
0
Participant gender:
Male
Male
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Novo Nordisk A/S
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.