CagriSema vs low-energy diet in 80 participants, phase 1 metabolism trial registration with no results
A ClinicalTrials.gov registration describes a two-part phase 1 trial in 80 people comparing subcutaneous CagriSema with a calorie-reduced diet, then giving CagriSema to all participants. No outcomes are posted.
2026 · Trial registration · n=80 · Human · Published October 8, 2026
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What the registration says
This is a trial registration in humans, with a listed enrollment of 80 participants, not a report of results. The registration states that the investigators will be "looking into how CagriSema influences metabolism (the process by which food is used to supply energy for the body) compared to a diet." CagriSema is described in the registration as a combination of cagrilintide and semaglutide.
The registration describes CagriSema as a new investigational medicine that cannot yet be prescribed by doctors but has previously been tested in humans. The listed phase is phase 1 and the listed status is active, not recruiting.
How the trial is designed
The study is split into two parts. In the first part, participants will either receive CagriSema or a weight loss diet described as calorie reduced, and the registration states that which treatment participants get in the first part is decided by chance. In the second part, all participants will receive CagriSema.
The arm descriptions state that CagriSema is given subcutaneously in a dose escalation regimen in Period A for up to 20 weeks, continuing until a maximum dose is reached in Period B for up to 52 weeks. Participants assigned to the Low Energy Diet arm receive a dietary intervention in Period A for up to 20 weeks, delivered as per a diet intervention manual, followed by subcutaneous CagriSema in Period B. The registration states the study will last about 1.5 years.
Reported dosing
The registration does not report any milligram amounts, injection frequency, or target maximum dose for cagrilintide or semaglutide. It states only that both are administered subcutaneously in a dose escalation regimen until a maximum dose is reached, over the stated Period A and Period B durations.
Limitations
This is a registration record, so no results, outcome measures, or safety findings are available here. Nothing can be said about whether metabolism differed between the CagriSema arm and the diet arm, because the record contains no data.
Other structural caveats: the listed enrollment is 80 and the listed phase is 1, so the trial is small and early; the comparison in the first part is an active dietary intervention rather than placebo; and in the second part all participants receive CagriSema, so there is no concurrent untreated comparison group after Period A. The registration text acknowledges only that, like all medicines, the study medicine may have side effects, without listing them.
Regulatory context
Cagrilintide, including the CagriSema coformulation with semaglutide, is not an FDA-approved drug for any use. The registration itself states that CagriSema cannot yet be prescribed by doctors.
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 CagriSema as an investigational medicine that is not yet prescribable but has been tested in humans before.
“CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors but has previously been tested in humans.”
In the first part of the trial, participants receive either CagriSema or a calorie-reduced weight loss diet.
“In the first part of the study, participants will either get CagriSema or a weight loss diet (calorie reduced).”
Assignment in the first part is randomized.
“Which treatment participants get in the first part of the study is decided by chance.”
CagriSema is given subcutaneously using a dose escalation regimen across two periods, without stated milligram amounts.
“Participants will receive subcutaneous (s.c.) dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen in Period A for up to 20 weeks”
The registration states an approximate total study duration of 1.5 years and notes that side effects are possible.
“Like all medicines, the study medicine may have side effects. The study will last for about 1.5 years.”
Common questions
Does the registration state how much cagrilintide or semaglutide participants receive?
No. It states only that CagriSema is administered subcutaneously in a dose escalation regimen in Period A for up to 20 weeks and continuing until a maximum dose is reached in Period B for up to 52 weeks. No milligram amounts are given.
Is there a comparison group?
In the first part of the study, participants are assigned by chance to either CagriSema or a calorie-reduced weight loss diet. In the second part, all participants receive CagriSema, so there is no longer a non-drug comparison group.
Are any results available?
No. This is a registration record with a listed status of active, not recruiting. It contains no outcome data on metabolism, weight, or adverse events.
How large and how long is the trial?
The listed enrollment is 80 participants, and the registration states the study will last for about 1.5 years.
Source
- 1.A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet (2026)Trial registrationhumann=80NCT NCT07184086