A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or Obese

What Was Tested

In this phase 1 trial, researchers set out to test Cagrilintide and GIP (Gastric Inhibitory Polypeptide).

This trial is being done to look at the safety and effect of combining cagrilintide and NNC0480-0389 in people living with overweight and obesity compared to taking cagrilintide alone.

In one period participants will get two medicines: cagrilintide and NNC0480-0389.

In the other period, participants will get cagrilintide together with a placebo version of NNC0480-0389.The placebo looks like the real treatment but does not have any active medicine in it.

It had four arms (groups): Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide (experimental), Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide (experimental), Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide (experimental) and Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to women only aged from 18 years up to 64 years.

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

Examples of who could join: Female at birth. Age 18-64 years (both inclusive) at the time of signing the informed consent. Body mass index (BMI) between 27.0 kilograms per square meter (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. Considered eligible with suitable veins for cannulation or repeated venepuncture, as judged by the investigator.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study intervention(s) or related products; any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol; treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening, including incretin-based treatment(s).

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

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

In the crossover set-up each of the participants took both Cagrilintide and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Cagrilintide.

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

It started in 2026-02-09 with completion listed for 2027-01-26.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Treatment Emergent Adverse Events (TEAEs) nausea, vomiting and diarrhoea.

It also tracked 1 secondary outcome, for example Total number of Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and GIP (Gastric Inhibitory Polypeptide) in 100 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 GIP (Gastric Inhibitory Polypeptide) compound page, all human trials.