A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese

What Was Tested

In this phase 1 trial, researchers set out to test Semaglutide.

The study is looking at possible new medicines for weight control in people with high body weight.

The study looks at how the new medicines work in the body.

The study consists of two parts.

It had two arms (groups): NNC0165-1875 (experimental) and Placebo (placebo comparator).

Participants will receive NNC0165-1875 alone in cohorts 1-5 (part 1) and NNC0165-1875 along with semaglutide in cohorts 6-11 (part 2).

Participants will receive placebo alone in cohorts 1-5 (part 1) and placebo along with semaglutide in cohorts 6-11 (part 2).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 88 actual participants took part.

It was open to men only.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Males, aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. Body weight greater than or equal to 70 kg.

The full record lists 3 inclusion and 0 exclusion criteria.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

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

It started in 2018-10-15 with completion listed for 2019-08-13.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of treatment emergent adverse events (TEAEs) (time frame: Day 1-36).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 88 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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