A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity
NCT04969939 · Completed
Last updated 2026-05-28This clinical trial is testing how safe the combination of the experimental drug NNC0165-1875 and semaglutide is in adults who have obesity.
What this study is testing ClinicalTrials.gov NCT04969939 ↗
Description as written by the study sponsor.
The study is looking at a new medicine to help people lose weight. In this study participants will either get semaglutide and NNC0165-1875 or semaglutide and a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants will get 2 injections per week, on the same day. Participants will have to take the study medicine by use of a pre-filled pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show participants how. The study will last for about 26 weeks. Participants will have 17 visits at the clinic with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed until 2 hours prior to the visit) for 8 hours before the visit.Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period. Women who are able to become pregnant can participate if they agree to use contraception during the study.
Treatments tested
- Semaglutide 2.4 mg and NNC0165-1875 2.0 mg Drug
NNC0165-1875 will be co-escalated once-weekly subcutaneously with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
- Semaglutide 2.4 mg and placebo 2.0 mg Drug
NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
- Semaglutide 2.4 mg and NNC0165-1875 1.0 mg Drug
NNC0165-1875 will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
- Semaglutide 2.4 mg and placebo 1.0 mg Drug
NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
| Main thing measured | Part 1: Number of Treatment-emergent Adverse Events (TEAEs) |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Conditions studied | Obesity |
| GLP-1 drugs | semaglutide |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04969939 ↗