CagriSema phase 3 registration enrolls 274 adults with type 2 diabetes on basal insulin

This is a ClinicalTrials.gov registration record, not a published results paper. It describes a phase 3 study in humans with a listed enrollment of 274 participants and a status of completed. The record states that the study "will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight."

The registration describes CagriSema as a combination of cagrilintide and semaglutide and states that it is "a new investigational medicine" and that "Doctors may not yet prescribe CagriSema." Participants take the study medicine together with their current diabetes treatment, described as once-daily insulin with or without metformin.

Assignment is randomized: the record states that participants receive either CagriSema or a placebo described as a "dummy" medicine, and that "which treatment they get is decided by chance." Four arms are listed: two CagriSema target-dose arms and two matched placebo arms.

The record states that for each participant the study lasts about one year. No outcome data, effect sizes, or adverse-event counts appear in this registration text, so nothing can be reported here about what the study found.

The registration describes schedules rather than milligram amounts. For the first arm, participants receive once-weekly subcutaneous injections of CagriSema at escalating doses every week in an 8-week dose escalation period until the target dose (dose 1) is achieved and maintained up to 32 weeks. For the second arm, the escalation period is 16 weeks, with the target dose (dose 2) maintained up to 24 weeks.

Placebo arms receive once-weekly subcutaneous injections of placebo matched to CagriSema dose 1 or dose 2 for 40 weeks. The record does not state the milligram content of cagrilintide or semaglutide in either target dose.

This is a registration-only record: no results, no statistical comparisons, and no safety tabulations are included in the source text, even though the status is listed as completed. Any statement about efficacy would go beyond what this document contains.

The target doses are identified only as "dose 1" and "dose 2" without numeric amounts, so the regimens cannot be quantified from this record. The population is narrow — people with type 2 diabetes already treated with once-daily basal insulin, with or without metformin — and findings from such a group would not necessarily describe other populations. Sponsor, funding, and site details are not included in the provided text.

Cagrilintide, the amylin analogue component of CagriSema, is not an FDA-approved drug for any use, according to this site's regulatory review. The registration itself states that CagriSema is an investigational medicine that doctors may not yet prescribe.