Gathering the record
Relay is organizing the evidence and source boundaries.
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.
60-Second Overview
Start with what it is, why it matters, what research has shown, and what remains unknown. The science follows after the orientation.
Start here. These four answers explain why the compound matters before the page introduces the deeper science.
Cagrilintide is an investigational, long-acting version of amylin, a hormone involved in fullness after eating. It is not an approved standalone medicine.
Researchers are studying whether amylin-related signaling can support weight management alone and in combination with semaglutide. Those are separate evidence records. A second question is whether combining distinct appetite signals changes both the observed effect and tolerability.
A 26-week mid-stage controlled trial reported amount-related average weight reduction in adults with overweight or obesity without diabetes. Larger confirmatory standalone trials are still underway.
Large confirmatory standalone results, long-term safety, durability, cardiovascular outcomes, and product standards remain incomplete. Sponsor-controlled trial injections do not establish reconstitution or stability rules for independent vials.
The research depth, routes, studies, and primary sources below explain how Relay knows—and where the evidence stops.
Research context
Published research has investigated this compound using the following study designs.
These records explain what researchers did. They are not instructions, recommendations, or a transferable protocol.
A randomized Phase 2 study evaluated sponsor-controlled cagrilintide in adults with overweight or obesity who did not have diabetes.
Reported study administration—not a recommendation.
Research at a glance
Evidence depth, confidence, and route context explain how Relay knows—not what anyone should do.
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 an instruction for an individual.
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: The amounts describe separate randomized research arms, not one individual sequence. The sources do not establish a consumer reconstitution process, generic-vial concentration, or post-reconstitution stability period. Amounts shown describe cited research exposure—not a dosage recommendation.
Detailed evidence
Start with the strongest supported conclusion and its main uncertainty. Claim-level records below show how the evidence changes by question, population, route, formulation, and study design.
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.
Questions people bring to the evidence
Research questions—not promises of benefit.
The dedicated RENEW 1 and RENEW 2 Phase 3 trials are active without posted results. No approved cagrilintide product label, consumer dose, or official product instructions were identified.
At 26 weeks, mean weight reduction ranged from 6.0% to 10.8% across cagrilintide arms versus 3.0% with placebo under the trial-product estimand.
The 2025 annual report described 11.8% average weight reduction with cagrilintide versus 2.3% with placebo at 68 weeks under an efficacy estimand.
Medicinal-chemistry work documents its design, while a 2025 mouse study implicated AMY1R and AMY3R signaling in weight and early food-intake effects.
Gastrointestinal events occurred in 41% to 63% across cagrilintide groups versus 32% with placebo; nausea was reported by 20% to 47% versus 18%.
All upper 90% confidence bounds for placebo-adjusted QTcF change remained below the prespecified 10-millisecond threshold.
Trial arms document protocol-specific doses, escalation, pens, populations, and follow-up. Those details explain the research; they are not recommendations.
Official trial records describe sponsor-controlled investigational injections, not a consumer product or a general method for handling unapproved material.
CagriSema combines cagrilintide with semaglutide. Its Phase 3 outcomes reflect the fixed-dose combination, while cagrilintide monotherapy must be judged from its own arms and trials.
Mechanisms
Cagrilintide is a lipidated, long-acting analogue of the pancreatic satiety hormone amylin with amylin- and calcitonin-receptor activity. Published human monotherapy evidence includes a 706-participant dose-finding weight-management trial and a 105-participant thorough-QT study. A sponsor-reported REDEFINE 1 component arm supplied longer Phase 3 context, while the dedicated RENEW 1 and RENEW 2 monotherapy trials remain active without results. Mouse knockout experiments support AMY1R and AMY3R involvement but should not be presented as demonstrated human receptor-specific outcomes.
A plausible mechanism can explain why a study was attempted. It does not prove that the compound improves a human outcome.
Studies
Study arms are reported for transparency. They describe what researchers did in a defined record and do not transfer across identities, routes, formulations, or populations.
A later trial phase can ask a more mature question, but it does not guarantee a positive result, regulatory approval, or relevance outside the studied population.
Randomized, double-blind, placebo-controlled study with a nested moxifloxacin positive control
Healthy adults
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.
Study administration: Once-weekly subcutaneous cagrilintide escalated to 4.5 mg or placebo
Limitations: This narrow healthy-volunteer study addressed cardiac repolarization at the tested exposure. It does not establish overall cardiovascular safety, long-term safety, or safety in obesity and diabetes populations.
Multicenter, randomized, double-blind, placebo-controlled and active-controlled dose-finding trial
Adults without diabetes with obesity, or overweight plus hypertension or dyslipidemia
At week 26, mean weight reduction under the trial-product estimand ranged from 6.0% to 10.8% across cagrilintide groups versus 3.0% with placebo. The 4.5 mg cagrilintide arm averaged 10.8% versus 9.0% with liraglutide 3.0 mg.
Study administration: Once-weekly subcutaneous cagrilintide across five dose arms, once-daily liraglutide 3.0 mg, or matched placebo
Limitations: This was a 26-week dose-finding study without diabetes. The reported arms and escalation schedule are research methods, not approved dosing guidance, and the highest-dose comparison does not establish universal superiority.
Wild-type and RAMP1/3-knockout mouse experiments
Male mice maintained on a high-fat diet
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.
Study administration: Cagrilintide, salmon calcitonin, or vehicle
Limitations: This was an animal mechanism study. It cannot establish which receptor effects dominate in people or predict an individual human outcome.
Randomized REDEFINE 1 component arm; sponsor-reported sub-analysis
Adults with obesity or overweight plus a weight-related complication, without diabetes
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.
Study administration: Once-weekly subcutaneous cagrilintide 2.4 mg or other randomized REDEFINE 1 interventions
Limitations: These monotherapy-arm numbers are from a sponsor annual report and efficacy estimand. A full peer-reviewed primary publication focused on the standalone cagrilintide comparison was not located by the cutoff.
Randomized, quadruple-masked, placebo-controlled parallel trial
Adults with obesity, or overweight plus a weight-related condition, without type 1 or type 2 diabetes
RENEW 1 was active, not recruiting, with no results posted as of the July 25, 2026 evidence cutoff.
Study administration: Once-weekly subcutaneous cagrilintide or placebo, with lifestyle-intervention counseling
Limitations: A registered design and endpoint list establish what researchers plan to measure, not whether cagrilintide is effective or safe for those outcomes.
Randomized, quadruple-masked, placebo-controlled parallel trial
Adults with overweight or obesity and type 2 diabetes
RENEW 2 was active, not recruiting, with no results posted as of the July 25, 2026 evidence cutoff.
Study administration: Once-weekly subcutaneous cagrilintide or placebo, with lifestyle-intervention counseling
Limitations: The registration does not demonstrate weight, glucose, or safety outcomes. Results are estimated after the current evidence cutoff.
Safety snapshot
Gastrointestinal events and administration-site reactions were the most frequent adverse-event categories in the Phase 2 weight-management trial.
Controlled human evidenceOne Phase 2 trial cannot define rare, long-term, or population-wide safety. Phase 3 monotherapy safety results remain pending.
Open sourceGastrointestinal events and administration-site reactions were the most frequent adverse-event categories in the Phase 2 weight-management trial.
Controlled human evidenceThe stated frequency is source-, product-, population-, route-, dose-, comparator-, and duration-specific; it is not a universal incidence estimate.
Open sourceNo source-qualified compound-specific warning or contraindication is encoded in the current record.
Evidence boundaryInvestigational; standalone Phase 3 RENEW program active, with no FDA-approved cagrilintide product 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.
The current record does not identify a reliable compound-specific pattern of events that caused study discontinuation.
Evidence boundaryThis is an evidence gap, not proof that discontinuations did not occur.
No compound-specific patient-facing urgent-action threshold is established in the current Relay record.
Evidence boundaryRelay does not infer emergency guidance from study discontinuations, mechanism, or incomplete adverse-event reporting.
Community
Built by the community
Every structured report adds useful context about research setup, outcomes, and unwanted effects as the community dataset grows.
Publicly anonymous by default. Your account keeps reports editable and helps reduce duplicate submissions.Sources
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