A Study on How NNC0174-1213 Works in People With Overweight or Obesity.

What Was Tested

In this phase 1 trial, researchers set out to test Cagrilintide and CagriSema (Cagrilintide + Semaglutide).

This study is testing a new study medicine to treat people living with overweight or obesity.

Participants will either get the new study medicine NNC0174-1213, a study medicine called "cagrilintide" or a placebo (a "dummy medicine" similar to the new study medicine and study medicine but without active ingredients).

It had six arms (groups): Part A: NNC0174-1213 (SD1-SD5) (experimental), Part A: Cagrilintide (SDA and SDB) (experimental), Part A: Placebo (experimental), Part B: NNC0174-1213 (MD1-MD5) (experimental) and Part B: Cagrilintide (MDA) (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 178 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

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

Examples of who could join: Age 18-55 years (both inclusive) at the time of signing the informed consent. Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. Body weight more than or equal to (\>=) 80.0 kilograms (kg) at screening. Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

The full record lists 5 inclusion and 16 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study intervention(s) or related products; exposure to an investigational medicinal product within 2 months or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening; participants report prior receipt of an amylin and/or calcitonin receptor agonist within the last 6 months.

How the Study Was Run

It was run as a randomized, sequential and double-blind study.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2024-12-03 with completion listed for 2026-07-20.

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

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213 (time frame: From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46)). Part B: Number of treatment emergent adverse events (TEAE) (time frame: From first administration (Day 1) to completion of the end of study visit (Day 67)).

It also tracked 4 secondary outcomes, for example Part A: AUC; area under the NNC0174 1213 plasma concentration-time curve, Part A: Cmax; maximum observed NNC0174 1213 plasma concentration, Part B: AUC; area under the NNC0174 1213 plasma concentration-time curve and Part B: Cmax; maximum observed NNC0174 1213 plasma concentration.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and CagriSema (Cagrilintide + Semaglutide) in 178 people.

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

More context: the Cagrilintide compound page and the CagriSema (Cagrilintide + Semaglutide) compound page, all human trials.