A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese

What Was Tested

The trial (phase 1) is built around Semaglutide.

The aim of this study is to find out how NNC0174-0833 taken with semaglutide works in people who are overweight or obese.

Both study medicines have been investigated on their own.

The study also looks at how the study medicines behave in participant's body and how they are removed from the participant's body.

It had two arms (groups): NNC0174-0833+Semaglutide (experimental) and Placebo (NNC0174-0833)+Semaglutide (active comparator).

Participants will receive placebo (NNC0174-0833) along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 96 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Male or female of non-childbearing potential, aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: any disorder at screening which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2018-07-25 with completion listed for 2020-06-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of treatment emergent adverse events (TEAEs) (time frame: From first administration of NNC0174-0833 (Day 1) to completion of the post-treatment follow-up (Day 176)).

It also tracked 4 secondary outcomes, for example AUC0-168h,AM833,SS: the area under the NNC0174-0833 plasma concentration-time curve from 0 to 168 hours at steady state, Cmax,AM833,SS: the maximum concentration of NNC0174-0833 in plasma at steady state, AUC0-168h,sema,SS: the area under the semaglutide plasma concentration-time curve from 0 to 168 hours at steady state and Cmax,sema,SS: the maximum concentration of semaglutide in plasma at steady state.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 96 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.