CagriSema obesity registration describes 80-week main phase and 80-week extension, 2:1 randomisation
A ClinicalTrials.gov registration for CagriSema in people living with obesity describes a randomised placebo-controlled main phase followed by an extension in which all participants receive CagriSema. No results are posted.
2026 · Trial registration · n=609 · Human · Published October 3, 2026
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What the registration says
This is a trial registration, not a results report, and it describes a study in humans — specifically, as the record puts it, "people living with obesity". The excerpt provided does not state how many participants are enrolled, and it reports no outcome data of any kind.
The registration states the study "has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'." In the main study, participants receive either CagriSema or a matched placebo, with assignment decided by chance, and the record notes that participants "are two times more likely to get CagriSema than placebo." The stated overall duration is about 3 years and 3 months.
How the arms are set up
The experimental arm is described as CagriSema given subcutaneously once weekly, first in a dose-escalation manner with increases every 4 weeks for up to 16 weeks, then as a maintenance dose once weekly for 64 weeks during the main phase. Participants in that arm then continue into the extension phase on one of three dose levels for 80 weeks, with the dose again decided by chance.
The comparator arm receives placebo matched to CagriSema subcutaneously once weekly for 80 weeks in the main phase. The registration states that participants who received placebo in the main study go on to receive CagriSema in the extension study, with flexible dose escalation for 80 weeks. Both the active product and the matched placebo are described as administered using a DV3384 pen-injector.
Reported dosing
The registration names no milligram amounts. It describes only the schedule and route: once-weekly subcutaneous injection, escalation every 4 weeks for up to 16 weeks, then a maintenance dose for 64 weeks, followed by one of three unspecified dose levels in the extension phase. The intervention is listed as CagriSema (Cagrilintide B and Semaglutide I), a coformulation rather than cagrilintide alone.
Limitations
Registrations describe what a study intends to do, not what it found. No efficacy or safety results appear in this excerpt, so nothing here supports any statement about how much weight participants lost or how well the weight loss was maintained.
The excerpt does not state the enrollment figure, the number of sites, the countries involved, eligibility criteria, or the funding sponsor. Specific dose levels are not disclosed, and the extension phase as described has no placebo arm, since participants from both main-phase groups receive CagriSema during the extension.
Regulatory context
Cagrilintide, including the CagriSema coformulation with semaglutide, is not an FDA-approved drug for any use. This status comes from the site's regulatory review, not from the registration described here.
Study-reported dosing
| Regimen as reported | Population | Route | Source |
|---|---|---|---|
| CagriSema subcutaneously once weekly in a dose escalation manner (dose increases every 4 weeks) for up to 16 weeks followed by CagriSema maintenance dose subcutaneously once weekly for 64 weeksNo milligram amounts are stated in the registration excerpt. | Participants living with obesity randomised to the CagriSema arm in the main phase | Subcutaneous | A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term (2026) Trial registrationHumann=609 |
| 1 of the 3 dose levels of CagriSema for 80 weeksThe specific dose levels are not disclosed; assignment is decided by chance. | Participants randomised to the CagriSema arm who continue into the extension phase | Subcutaneous | A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term (2026) Trial registrationHumann=609 |
| Placebo matched to CagriSema subcutaneously once weekly for 80 weeksThese participants are described as receiving CagriSema with flexible dose escalation for 80 weeks in the extension phase. | Participants randomised to the placebo comparator arm in the main phase | Subcutaneous | A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term (2026) Trial registrationHumann=609 |
Claims and where they come from
Each statement below is followed by the passage of the source record it was checked against.
The main phase randomises participants to CagriSema or matched placebo at a 2:1 ratio.
“Participants are two times more likely to get CagriSema than placebo.”
The CagriSema arm escalates every 4 weeks for up to 16 weeks, then continues a maintenance dose weekly for 64 weeks.
“Participants will receive CagriSema subcutaneously once weekly in a dose escalation manner (dose increases every 4 weeks) for up to 16 weeks followed by CagriSema maintenance dose subcutaneously once weekly for 64 weeks in the main phase of the study.”
Participants assigned to placebo in the main study cross over to active treatment in the extension.
“If participants get placebo in the main study, participants will get CagriSema in the extension study.”
The registration lists a total study duration of roughly 3 years and 3 months.
“The study will last for about 3 years and 3 months.”
The coformulation of cagrilintide and semaglutide is delivered subcutaneously with a specified pen-injector.
“CagriSema (Cagrilintide B and Semaglutide I) will be administered subcutaneously using DV3384 pen-injector.”
Common questions
Does this registration report any weight-loss results?
No. The excerpt describes the design only — two parts, randomised assignment, dosing schedule and duration. It contains no outcome data.
Is there a placebo group?
Yes, in the main phase. The record describes a placebo comparator arm receiving placebo matched to CagriSema subcutaneously once weekly for 80 weeks. In the extension phase, that group is described as receiving CagriSema.
What doses are being tested?
The registration does not give milligram amounts. It describes escalation every 4 weeks for up to 16 weeks, a maintenance dose for 64 weeks, and one of three unspecified dose levels during the 80-week extension.
Is this cagrilintide alone?
No. The intervention is listed as CagriSema (Cagrilintide B and Semaglutide I), a coformulation administered subcutaneously using a DV3384 pen-injector.
Source
- 1.A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term (2026)Trial registrationhumann=609NCT NCT07011667