Phase 2
Completed N=24
A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity
Obesity
Source: ClinicalTrials.gov NCT04969939 ↗
Enrolled (actual)
24
Serious AEs
2.5%
Results posted
Jan 2026
Primary outcomePrimary: Part 1: Number of Treatment-emergent Adverse Events (TEAEs) — 56; 71; 37 Events
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Number of Treatment-emergent Adverse Events (TEAEs) |
56; 71; 37 | — |
| PRIMARY Part 2b: Percentage Change in Body Weight |
-5.55; -3.06 | 0.0437 sig |
| SECONDARY Part 2b: Change in Body Weight (kg) |
-4.54; -2.23 | — |
| SECONDARY Part 2b: Change in Glycosylated Haemoglobin (HbA1c) |
-0.17; -0.17 | — |
| SECONDARY Part 2b: Change in Fasting Plasma Glucose (FPG) |
0.08; -0.02 | — |
| SECONDARY Part 2b: Change in Fasting Insulin |
-14.10; -8.10 | — |
| SECONDARY Part 2b: Change in Waist Circumference |
-4.80; -2.69 | — |
| SECONDARY Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline) |
1.00; 1.07 | — |
| SECONDARY Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) |
1.02; 1.08 | — |
| SECONDARY Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) |
1.01; 1.08 | — |
| SECONDARY Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline) |
0.96; 1.04 | — |
| SECONDARY Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline) |
0.96; 1.03 | — |
| SECONDARY Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline) |
0.87; 1.07 | — |
| SECONDARY Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs) |
220; 45; 56 | — |
| SECONDARY Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs) |
2; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- BMI 30.0-45.0 kg/m^2 (both inclusive) at the screening visit.
Exclusion Criteria
- HbA1c greater than or equal to 48 mmol/mol (6.5%) as measured by a central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
- Treatment with glucose-lowering agent(s) within 90 days before screening.
Data sourced from ClinicalTrials.gov (NCT04969939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.