Fixed-dose amylin analogue / GLP-1 receptor agonist combination
CagriSema is an investigational once-weekly combination of cagrilintide and semaglutide. Large Phase 3 trials found substantial average weight reduction, and several diabetes trials found improved blood-sugar control. A U.S. application is under review, but CagriSema is not FDA approved.
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Depth and confidence summarize the research record—not effectiveness, safety, or a recommendation.
Multiple peer-reviewed Phase 3 trials cover weight and glycaemic outcomes across several defined populations.
Research depth describes how large and mature the overall record is. It does not tell you whether the results were positive.
Large randomized trials are consistent, while regulatory review, long-term outcomes, rare events, and durability remain unresolved.
Confidence describes how reliable and consistent the conclusions are. It can be high for one outcome and low for another.
The strongest evidence type shows what the best-supported conclusions are actually based on.
Human findings are more directly relevant than animal or laboratory results, but they still apply only to the populations and outcomes studied.
Route-specific record
These are exposures used in cited research for a specific route and population—not a suggested amount.
Half-life describes how long it takes the measured amount in the body to fall by half. It is not a dosing recommendation.
Evidence can change by administration method. Findings from one route should not automatically be applied to another.
Evidence boundary: CagriSema remains investigational. Component amounts are paired protocol arms, not separate mixing instructions, an approved schedule, or evidence that separately sourced products are equivalent. Amounts shown describe cited research exposure—not a dosage recommendation.
Practical starting point
Common goals and questions—not recommendations or promises of benefit.
The overview, studies, and source ledger below explain what supports each label—and where the evidence stops.
The short version
CagriSema is an investigational once-weekly combination of cagrilintide and semaglutide. Large Phase 3 trials found substantial average weight reduction, and several diabetes trials found improved blood-sugar control. A U.S. application is under review, but CagriSema is not FDA approved.
Includes peer-reviewed REDEFINE and REIMAGINE Phase 3 publications, the REDEFINE 1 blood-pressure analysis, and official development status through July 25, 2026.
What the evidence says
Two pivotal peer-reviewed weight-management trials randomized 3,417 adults without diabetes and 1,206 adults with type 2 diabetes, supported by three additional peer-reviewed Phase 3 diabetes trials.
This is the strongest supported conclusion in the current human evidence—not a summary of every claim made about the compound.
The FDA decision and final label, long-term cardiovascular and renal outcomes, rare adverse events, durability after discontinuation, and how outcomes compare across broader populations.
Keeping the main uncertainty visible prevents an early or promising finding from looking more settled than it is.
The evidence story
Importance shows how much an item changes the evidence story. Quality shows how much confidence the design deserves. A strong negative study can score highly on both.
Importance and quality answer different questions. A rigorous study can be highly important even when it challenges a popular claim.
Under the efficacy estimand, HbA1c changed by -1.8 and -1.5 percentage points across the two CagriSema groups versus -0.1 with placebo. Body weight changed by -13.8% and -11.8% versus -1.4%.
For the primary efficacy estimand, HbA1c changed by -1.91 percentage points with CagriSema 2.4 mg/2.4 mg versus -1.75 with semaglutide 2.4 mg. The study also reported greater average weight reduction with the combination in the active comparison.
HbA1c changed by -2.33 and -2.10 percentage points across the two CagriSema groups versus -0.66 with placebo. Body-weight reductions were approximately 10% to 12%, and no severe hypoglycemia was reported.
Blood pressure changed by -10.9/-5.4 mm Hg with CagriSema versus -2.8/-1.7 mm Hg with placebo at week 68.
Under the treatment-policy estimand, mean body-weight change was -20.4% with CagriSema versus -3.0% with placebo at week 68. Gastrointestinal adverse events were reported by 79.6% versus 39.9% and were mainly transient and mild to moderate.
Administration and handling
Published Phase 3 studies describe once-weekly subcutaneous administration using protocol-specific doses and escalation. These details explain the trials; they are not approved dosing instructions, a consumer schedule, or an individualized recommendation.
No FDA-approved CagriSema label, public consumer storage standard, or regulator-approved reconstitution procedure was identified. Trial-product handling does not establish identity, sterility, compatibility, concentration, storage, or stability for unapproved material or separately sourced components.
Primary-source ledger
2026-06-07 · PMID 42251860 · NCT06323174 · DOI 10.1016/S2213-8587(26)00126-9
2026-06-07 · PMID 42251859 · NCT06065540 · DOI 10.1016/S2213-8587(26)00125-7
2026-06-07 · PMID 42251856 · NCT06323161 · DOI 10.1016/S0140-6736(26)01022-6
2026-06-07 · NCT06065540
2026-02-04
2025-12-02 · PMID 41328546 · NCT05567796 · DOI 10.1161/HYPERTENSIONAHA.125.26055
2025-06-22 · PMID 40544433 · NCT05567796 · DOI 10.1056/NEJMoa2502081
2025-06-22 · PMID 40544432 · NCT05394519 · DOI 10.1056/NEJMoa2502082