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A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity

Plain-language guide to NCT07557953: phase 1 randomized trial of Cagrilintide and CagriSema (Cagrilintide + Semaglutide), 120 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07557953
Phase
phase 1
Status
recruiting participants
Start
2026-04-30
Completion (planned or actual)
2027-04-13
Participants
120 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Overweight; Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

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

The study is testing cagrilintide, a study medicine, to understand how it affects food intake and appetite in people with overweight or obesity.

Participants will receive either cagrilintide or placebo, and which treatment participants get is decided by chance.

Cagrilintide is the treatment being tested, while placebo looks like the study medicine but does not contain any active medicine.

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

Participant will receive Cagrilintide subcutaneously once weekly for up to 17 weeks.

Participant will receive placebo matched to Cagrilintide subcutaneously once weekly for up to 17 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 120 planned participants were the target.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Male or female (sex at birth). Age 18-64 years (both inclusive) at the time of signing the informed consent. Body mass index (BMI) is greater than or equal to (≥) 27.0 kg/m\^2 at screening. Over-weight should be due to excess adipose tissue, as judged by the investigator.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study intervention(s) or related products; female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method; presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Cagrilintide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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, care provider, investigator and outcomes assessor.

It started in 2026-04-30 with completion listed for 2027-04-13.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box (time frame: From baseline (Day 2) to end of treatment (Day 127)).

It also tracked 9 secondary outcomes, for example Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box, Change in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box, Absolute change in energy intake of high fat + sweet, high fat + non-sweet, low fat + sweet, low fat + non sweet in the evening snack box, Change in mean postprandial appetite score (AS) based on Visual Analogue Scale (VAS), Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption and Change in mean postprandial VAS ratings of: visual appearance, taste and overall pleasantness.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and CagriSema (Cagrilintide + Semaglutide) in 120 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.

Our Notes on the Compounds

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

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.