A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese

What Was Tested

The trial (phase 1) is built around Semaglutide.

The study is investigating new medicines for weight control in people with high body weight.

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

Participants will get semaglutide and either NNC0165-1562 or "dummy" medicine -which treatment participants get is decided by chance.

It had two arms (groups): NNC0165-1562 + Semaglutide (experimental) and Placebo (NNC0165-1562) + Semaglutide (experimental).

Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks.

Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 37 actual participants took part.

It was open to people of any sex aged from 19 years up to 55 years.

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

Examples of who could join: Male or female, aged 19-55 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. Obesity should be due to excess adipose tissue, as judged by the investigator.

The full record lists 2 inclusion and 2 exclusion criteria.

How the Study Was Run

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

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2018-06-18 with completion listed for 2019-07-27.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of treatment emergent adverse events (TEAEs) (time frame: Week 0-25).

It also tracked 2 secondary outcomes, for example AUC0-168h,1562,SS; the area under the NNC0165-1562 plasma concentration-time curve from time 0 to 168 hours at steady state and AUC0-168h,sema,SS; the area under the semaglutide plasma concentration time curve from 0 to 168 hours at steady state.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 37 people.

Its size is small, so on its own it can only give an early look.

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.