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A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
Plain-language guide to NCT07564414: phase 3 randomized trial of Cagrilintide and Semaglutide, 2500 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07564414
- Phase
- phase 3
- Status
- recruiting participants
- Start
- 2026-05-21
- Completion (planned or actual)
- 2028-02-23
- Participants
- 2500 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Obesity; Type 2 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Cagrilintide and Semaglutide.
This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight.
Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance.
It had three arms (groups): one (experimental), one (active comparator) and Semaglutide (active comparator).
Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks.
The registry classes the interventions as drug.
Who Took Part
2500 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 assigned at birth, inclusive of all gender identities). Age 18 years or above at the time of signing the informed consent. BMI≥ 35.0 kg/m\^2.
The full record lists 4 inclusion and 2 exclusion criteria.
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.
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 2026-05-21 with completion listed for 2028-02-23.
It ran at 303 sites in United States (99), Canada (21), Argentina (15), Poland (15), South Africa (15) and Bulgaria (14).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Relative change in body weight (time frame: From randomisation (week 0) to end of treatment (week 72)).
It also tracked 25 secondary outcomes, for example Relative change in body weight, Change in Body Mass Index (BMI), Change in waist circumference, Mean change in body weight, Number of participants who achieve a BMI less than (<) 30 kg/m^2 and Number of participants who achieve BMI <27 kg/m^2.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 2500 people.
With 2500 participants it is a large trial for this field.
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.