Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events

What Was Tested

This registered phase 1 trial tested Cagrilintide and CagriSema (Cagrilintide + Semaglutide).

Participants will get either Cagrilintide (the treatment being tested) or Placebo (a treatment that has no active medicine in it).

Which treatment participant will get is decided by chance.

It had two arms (groups): Cagrilintide (experimental) and Placebo (placebo comparator).

Participants will receive Cagrilintide for 26 weeks.

Participants will receive placebo matched to Cagrilintide for 26 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 114 planned participants were the target.

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: Male or female (sex at birth). Age 18 years or above at the time of signing the informed consent. History of documented treatment with GLP-1-RA medications with gastrointestinal (GI) adverse effects as the main reason for treatment discontinuation. Not suitable for re-initiation of GLP-1-RA treatment based on medical history and investigator judgement. Body mass index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m\^2).

How the Study Was Run

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

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

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

As a double-blind Cagrilintide 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 2026-05-29 with completion listed for 2027-11-19.

It ran at 13 sites in United States (13).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and CagriSema (Cagrilintide + Semaglutide) in 114 people.

It is still recruiting; 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.