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A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight

Plain-language guide to NCT06388187: phase 3 randomized trial of Cagrilintide and Semaglutide, 300 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06388187
Phase
phase 3
Status
completed
Start
2024-06-24
Completion (planned or actual)
2026-04-22
Participants
300 (actual)
Design
randomized, quadruple-blind, treatment
Conditions studied
Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test Cagrilintide and Semaglutide.

This study will look at how well CagriSema helps people with excess body weight lose weight.

CagriSema cannot yet be prescribed by doctors.

It had four arms (groups): one (experimental), one (placebo comparator), one (active comparator) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 300 actual participants took part.

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. Age above or equal to 18 years at the time of signing informed consent. Body Mass index (BMI) greater than or equal to (≥) 30.0 kilogram per meter square (kg/m\^2) or. BMI ≥27.0 kg/m2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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

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 2024-06-24 with completion listed for 2026-04-22.

It ran at 25 sites in United States (7), United Kingdom (6), Germany (5), France (4) and Canada (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Relative change in body weight (time frame: From baseline (week 0) to end of treatment (week 68)).

It also tracked 13 secondary outcomes, for example Change in waist circumference, Change in systolic blood pressure, Ratio to baseline in lipids: Total cholesterol, Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol, Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol and Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 300 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 Semaglutide compound page, all human trials.

Our Notes on the Compounds

Cagrilintide: An investigational long-acting amylin analog; CagriSema combines it with semaglutide.

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

CagriSema (Cagrilintide + Semaglutide): A once-weekly fixed combination of cagrilintide (amylin analog) and semaglutide (GLP-1) tested in the phase 3 REDEFINE program.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.