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A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity
Plain-language guide to NCT07597018: phase 1 randomized trial of Cagrilintide and Semaglutide, 234 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07597018
- Phase
- phase 1
- Status
- recruiting participants
- Start
- 2026-05-18
- Completion (planned or actual)
- 2027-05-28
- Participants
- 234 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Obesity; Overweight
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Cagrilintide and Semaglutide.
This clinical study is testing two versions of the study medicine cagrilintide.
The purpose of the study is to compare these two versions to understand their effects in participants with overweight or obesity.
Participants will receive either cagrilintide version D or cagrilintide version B, and which treatment participants receive is decided by chance.
It had four arms (groups): Cagrilintide B and Placebo Semaglutide I (experimental), Cagrilintide D-Injection site 1 (experimental), Cagrilintide D-Injection site 2 (experimental) and Cagrilintide D-Injection site 3 (experimental).
Participants will receive Cagrilintide B and Placebo semaglutide I subcutaneously once weekly for up to 17 weeks.
Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.
Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 234 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: Aged 18-64 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 27.0 and 34.9 kilograms per square metre (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: previous participation in study(s) with an amylin analogue. participation is defined as randomisation; any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
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.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Cagrilintide study: the participants and staff both knew the treatment.
It started in 2026-05-18 with completion listed for 2027-05-28.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 13 secondary outcomes, for example Number of treatment-emergent adverse events (TEAEs) and Number of treatment-emergent serious adverse events (TESAEs).
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Cagrilintide and Semaglutide in 234 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 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
- Cagrilintide in the library
- Semaglutide in the library
- CagriSema (Cagrilintide + Semaglutide) in the library
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.