A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity

What Was Tested

This registered phase 2 trial tested Semaglutide.

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.

It had four arms (groups): one (experimental), one (placebo comparator), one (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 120 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes mellitus; treatment with glucose-lowering agent(s) within 90 days before screening.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-07-15 with completion listed for 2022-12-06.

It ran at 25 sites in United States (25).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Part 1: Number of Treatment-emergent Adverse Events (TEAEs). Part 2b: Percentage Change in Body Weight (time frame: Part 2: Randomisation (week 32), end of treatment (week 48)).

It also tracked 13 secondary outcomes, for example Part 2b: Change in Body Weight (kg), Part 2b: Change in Glycosylated Haemoglobin (HbA1c), Part 2b: Change in Fasting Plasma Glucose (FPG), Part 2b: Change in Fasting Insulin, Part 2b: Change in Waist Circumference and Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 120 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.