CagriSema weight-loss registration lists four weekly injection arms plus a two-year extension
A ClinicalTrials.gov registration describes a randomised comparison of CagriSema, cagrilintide, semaglutide and placebo in people with excess body weight, followed by a drug-free extension phase.
2026 · Trial registration · n=3400 · Human · Published October 2, 2026
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What the registration describes
This is a registration record for a human trial in participants with excess body weight; the excerpt does not state how many participants are enrolled, so no sample size is reported here. The record describes two parts: "First part is the main study and second part is the extension study." During the main study, participants receive one of four study medicines, and the record states that "Which treatment participants get is decided by chance."
According to the registration, the main part compares CagriSema with a "dummy" medicine and with two other medicines, cagrilintide and semaglutide. All assigned treatments are given as one injection once a week, described as injected with a thin needle, typically in the stomach, thighs or upper arms.
What it plans to measure
The registration states that the main study will look at how well CagriSema helps participants with excess body weight lose weight compared with placebo and with the two single agents. No results are included in this excerpt.
For the extension part, the record states that not all participants will continue, that study staff will tell each participant whether they continue, and that the extension will look at what happens to body weight and diseases related to excess body weight after participants stop taking the study medicine. The main study is listed as lasting about 1½ years and the extension another 2 years.
Reported dosing
The registration describes schedules rather than milligram amounts. Participants randomised to the CagriSema arm are listed as receiving cagrilintide and semaglutide once-weekly after a dose escalation period of 16 weeks, during a maintenance period of 52 weeks in the main phase, with 97 weeks in the extension phase.
Participants in the cagrilintide arm are listed as receiving cagrilintide subcutaneously plus placebo matching semaglutide once-weekly after a 16-week dose escalation period during a 52-week maintenance period, and participants in the semaglutide arm the mirror-image assignment. Participants in the placebo arm are listed as receiving placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeks.
Limitations
This is a registration record, not a results publication: no outcome data, statistics or safety findings appear in the excerpt. The excerpt does not state enrollment, the number of sites, participant age or body-mass-index criteria, or funding and author affiliations.
The excerpt also gives no milligram doses for cagrilintide or semaglutide, and no definition of the weight-loss endpoints or the analysis approach. Because participants receive no study medicine during the extension, any observations in that phase describe what follows treatment discontinuation rather than ongoing treatment effects.
Regulatory context
Cagrilintide is an investigational amylin analogue and is not an FDA-approved drug for any use. That status comes from this site's regulatory review, not from the registration described above.
Study-reported dosing
| Regimen as reported | Population | Route | Source |
|---|---|---|---|
| cagrilintide and semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks in the main phase; 97 weeks in the extension phaseThe excerpt states no milligram amounts for either component. | Participants randomised to the CagriSema experimental arm | Subcutaneous | A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (2026) Trial registrationHumann=3400 |
| cagrilintide s.c. and placebo matching to semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeksDouble-dummy design; no milligram amounts are stated. | Participants randomised to the cagrilintide active-comparator arm | Subcutaneous | A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (2026) Trial registrationHumann=3400 |
| semaglutide s.c. and placebo matched to cagrilintide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeksNo milligram amounts are stated. | Participants randomised to the semaglutide active-comparator arm | Subcutaneous | A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (2026) Trial registrationHumann=3400 |
| placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeksThis arm is listed as included in the extension phase for 97 weeks. | Participants randomised to the placebo comparator arm | Subcutaneous | A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (2026) Trial registrationHumann=3400 |
Claims and where they come from
Each statement below is followed by the passage of the source record it was checked against.
The registration describes a two-part design with a main study and an extension study.
“This study has 2 parts: First part is the main study and second part is the extension study.”
Treatment assignment is randomised among four options, including a placebo comparator.
“Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance.”
All study medicine is given as one weekly subcutaneous injection.
“They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms.”
The CagriSema arm is listed as a 16-week dose escalation followed by a 52-week maintenance period.
“Participants will receive cagrilintide and semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks in the main phase.”
No study medicine is given during the extension phase.
“If participants continue in the extension study, they will not receive any study medicine during the extension.”
Stated durations are about 1½ years for the main study and 2 years for the extension.
“The main study will last for about 1½ years and the extension study will last for another 2 years.”
Common questions
Was there a control group?
Yes. The registration lists a placebo comparator arm in which participants receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeks, alongside cagrilintide and semaglutide active-comparator arms.
Does the registration report any weight-loss results?
No. The excerpt describes what the study will look at, stating that the main study will compare CagriSema with a "dummy" medicine and with cagrilintide and semaglutide, but it contains no outcome data.
How many people are enrolled?
The excerpt provided does not state an enrollment figure, so no sample size is reported here.
What happens in the extension phase?
The registration states that not all participants continue, that study staff will tell participants whether they continue, and that no study medicine is given during the extension, which looks at body weight and related diseases after participants stop taking the study medicine.
Source
- 1.A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (2026)Trial registrationhumann=3400NCT NCT05567796