Long-acting amylin analogue
Cagrilintide is an investigational once-weekly amylin analogue being studied for weight management. A controlled Phase 2 trial showed meaningful average weight reduction, and dedicated Phase 3 RENEW trials are underway. It is not FDA approved, and results from CagriSema do not automatically describe cagrilintide alone.
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Depth and confidence summarize the research record—not effectiveness, safety, or a recommendation.
A randomized Phase 2 monotherapy trial and narrow pharmacology studies are available, while dedicated Phase 3 outcomes remain pending.
Research depth describes how large and mature the overall record is. It does not tell you whether the results were positive.
The Phase 2 weight signal is controlled, but the longer Phase 3 monotherapy signal is sponsor-reported and dedicated RENEW trials have no results yet.
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: Cagrilintide is investigational. Trial arms explain the research design and are not approved amounts, escalation instructions, or proof of long-term standalone benefit. 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.
What the evidence says
A 706-participant randomized Phase 2 monotherapy trial reported dose-related average weight reduction through 26 weeks; a 302-participant Phase 3 component arm later produced a sponsor-reported 68-week signal.
This is the strongest supported conclusion in the current human evidence—not a summary of every claim made about the compound.
Whether dedicated RENEW Phase 3 trials confirm long-term standalone efficacy and safety, including rare adverse events, cardiometabolic outcomes, durability, and results in type 2 diabetes.
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.
RENEW 1 was active, not recruiting, with no results posted as of the July 25, 2026 evidence cutoff.
RENEW 2 was active, not recruiting, with no results posted as of the July 25, 2026 evidence cutoff.
The sponsor reported an average 11.8% body-weight reduction with cagrilintide versus 2.3% with placebo under the efficacy estimand, with more than 30% versus less than 5% reaching at least 15% weight reduction.
Weight and early food-intake effects were attenuated when RAMP1 and RAMP3 were absent, supporting a role for AMY1R and AMY3R signaling in this mouse model.
The upper bounds of the 90% confidence intervals for placebo-adjusted QTcF change remained below the prespecified 10-millisecond threshold at all measured time points.
Administration and handling
Published and registered studies describe once-weekly subcutaneous administration using protocol-specific doses, escalation schedules, and investigational pens. These details explain how trials were run; they are not approved consumer dosing instructions or individualized recommendations.
No FDA-approved standalone cagrilintide product, public consumer storage label, or regulator-approved reconstitution procedure was identified. Sponsor-controlled trial handling does not establish identity, sterility, concentration, storage, or stability for unapproved material.
Primary-source ledger
2026-06-30 · NCT07220642
2026-04-21 · NCT07220759
2026-02-04
2025-07-03 · PMID 40609154 · DOI 10.1016/j.ebiom.2025.105836
2025-06-22 · PMID 40544432 · NCT05394519 · DOI 10.1056/NEJMoa2502082
2024-09-16 · PMID 39279639 · NCT05804162 · DOI 10.1111/dom.15951
2021-11-16 · PMID 34798060 · NCT03856047 · DOI 10.1016/S0140-6736(21)01751-7
2021-07-21 · PMID 34288673 · DOI 10.1021/acs.jmedchem.1c00565