Cagrilintide
Evidence: A-/B+ — Established Human EvidenceMetabolic / Weight Management
Evidence Snapshot
What this grade covers
A for molecular identity; B for controlled cagrilintide-monotherapy weight-management evidence; A/B for Phase 3 CagriSema combination efficacy within exact trial populations; D/E for FDA approval, compounded-product equivalence, long-term cardiovascular benefit, safety, or consumer dosing.
Regulatory Context
Investigational; not FDA-approved as a standalone product. A fixed-dose combination with semaglutide (CagriSema) had a New Drug Application filed with the FDA in December 2025, with a decision expected in 2026.
Research Takeaway
Mimics endogenous amylin, a pancreatic satiety hormone, via a brain pathway distinct from GLP-1 agonists.
See all 12 evidence claims →Quick Summary
Cagrilintide is a long-acting amylin analog studied for weight management, both alone and combined with semaglutide (as CagriSema). It mimics the satiety hormone amylin to reduce food intake, and has shown meaningful weight loss in completed Phase 2 and Phase 3 human trials.
Mechanism & Research Overview
Mimics endogenous amylin (a pancreatic satiety hormone) via a brain pathway distinct from GLP-1 agonists; a long half-life (~159-195 hours per industry sources) supports once-weekly dosing. 'CagriSema' is the fixed-dose combination product (cagrilintide + semaglutide) and is not a synonym for cagrilintide itself.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
Mimics endogenous amylin, a pancreatic satiety hormone, via a brain pathway distinct from GLP-1 agonists.
Sources: Once-weekly cagrilintide for weight management in people with overweight or obesity: a phase 2 trial; Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1)
Supported
Cagrilintide is designed with an extended half-life supporting once-weekly dosing; the specific half-life figure could not be independently verified because the cited chemistry-development source was paywalled beyond its title, journal, and DOI.
Sources: Development of Cagrilintide, a Long-Acting Amylin Analogue
Supported
In REDEFINE 1, combination cagrilintide plus semaglutide produced -20.4% weight change versus -3.0% for placebo over 68 weeks.
Sources: Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1)
Supported
In a Phase 2 monotherapy trial, cagrilintide produced 6.0-10.8% weight loss versus 3.0% for placebo over 26 weeks.
Sources: Once-weekly cagrilintide for weight management in people with overweight or obesity: a phase 2 trial
Supported
A New Drug Application for CagriSema (cagrilintide plus semaglutide) was filed with the FDA in December 2025; cagrilintide is not FDA-approved as a standalone product.
Supported
Cagrilintide is a stable, lipidated, long-acting analogue of human amylin engineered for once-weekly exposure. It must remain a distinct identity from native human amylin/islet amyloid polypeptide, pramlintide, salmon calcitonin and human calcitonin, semaglutide, CagriSema as a combination product, other amylin- or calcitonin-family receptor agonists, and marketplace 'cagrilintide' products without confirmed sequence, acylation, counterion, purity, or formulation. FDA GSRS identifies cagrilintide as an amylin-analogue peptide substance; the presence of a UNII record does not imply FDA approval, safety review, effectiveness, or permission to compound.
Sources: FDA GSRS/UNII Cagrilintide Substance Record; Development of Cagrilintide, a Long-Acting Amylin Analogue
Supported
CagriSema combines cagrilintide with semaglutide. Early Phase 1b and Phase 2 combination studies, and the Phase 3a REDEFINE 1 and REDEFINE 2 trials, describe the combination product and demonstrate clinically important CagriSema weight reduction, but these findings cannot be used to establish the magnitude of cagrilintide-monotherapy efficacy. REIMAGINE program studies evaluating CagriSema against its individual components do not permit subtracting semaglutide's contribution from the combined result, and do not establish an FDA-approved fixed-dose product or cardiovascular outcomes.
Sources: Cagrilintide Plus Semaglutide Phase 1b Trial; REDEFINE 2 Cagrilintide-Semaglutide Trial; Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1)
Supported
REDEFINE 2, a Phase 3a trial in adults with obesity and type 2 diabetes, reported significantly greater weight reduction with cagrilintide-semaglutide (CagriSema) than placebo in that population. REDEFINE 3 is a dedicated, not-yet-complete cardiovascular-outcomes trial for the combination; cardiovascular-event-reduction benefit is not yet established for cagrilintide or CagriSema pending its results.
Sources: REDEFINE 2 Cagrilintide-Semaglutide Trial; REDEFINE 3 Cardiovascular Outcomes Trial Registry; REDEFINE 1 Trial Registry
Supported
As of the research cutoff, no FDA-approved cagrilintide or CagriSema product exists. FDA warning letters in 2024 and the March 2026 Prime Sciences letter identify U.S.-marketed cagrilintide products as unapproved new drugs and describe additional public-health risks specific to injectable unapproved products. An FDA UNII/GSRS identity record does not constitute or imply approval.
Sources: FDA Prime Sciences Warning Letter for Unapproved Cagrilintide and Mazdutide Products
Supported
Beyond gastrointestinal and injection-site effects already described, important unresolved cagrilintide/CagriSema safety uncertainties include dehydration and secondary renal injury from persistent gastrointestinal symptoms; gallbladder and pancreatobiliary events; delayed gastric emptying and its effect on absorption of concomitant oral medicines; hypoglycemia when used with insulin or insulin secretagogues; resting-heart-rate and cardiovascular effects; unknown long-term calcitonin/amylin-family receptor consequences; psychiatric and eating-disorder considerations; pregnancy, lactation, reproductive, pediatric, hepatic, and renal gaps; anti-drug antibodies, aggregation, degradation, impurities, sterility, and endotoxin risk; and the uncertain identity and potency of products sold outside controlled trials.
Sources: Once-weekly cagrilintide for weight management in people with overweight or obesity: a phase 2 trial; Efficacy and safety of co-administered cagrilintide and semaglutide for weight management in people with type 2 diabetes
Supported
As of August 10, 2026, cagrilintide remains investigational in the United States and is being advanced in a dedicated Phase 3 RENEW program; FDA has also taken enforcement action against unapproved marketed cagrilintide products.
Sources: Innovation and therapeutic focus - Annual Report 2025; FDA Prime Sciences Warning Letter for Unapproved Cagrilintide and Mazdutide Products
Supported
Grey-market or compounded cagrilintide products are unapproved and are not demonstrated to be equivalent to the clinical-trial material with respect to identity, purity, sterility, stability, or pharmacokinetics.
Sources: FDA Prime Sciences Warning Letter for Unapproved Cagrilintide and Mazdutide Products
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
Gastrointestinal effects such as nausea, constipation, and diarrhea are common and dose-related across Phase 2/3 trials, reported in 39.9-79.6% of participants depending on group/trial.Safety Consideration
Cagrilintide is not FDA-approved as a standalone product, so the real-world manufacturing quality of any non-prescription product is unverified.Safety Consideration
Long-term safety beyond the trial duration is not yet established; the longest completed trial reviewed was 68 weeks (REDEFINE 1).Safety Consideration
Dehydration and secondary renal injury from persistent GI symptoms, gallbladder and pancreatobiliary events, delayed gastric emptying affecting oral-drug absorption, hypoglycemia with insulin or insulin secretagogues, resting-heart-rate/cardiovascular effects, unknown long-term amylin/calcitonin-family receptor consequences, psychiatric and eating-disorder considerations, pregnancy/lactation/reproductive/pediatric/hepatic/renal gaps, immunogenicity (anti-drug antibodies, aggregation, degradation, impurities, sterility, endotoxin), and uncertain identity/potency of nontrial marketplace products are unresolved for cagrilintide and CagriSema.
Research Areas Being Studied
Primarily weight management and, in combination, type 2 diabetes.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
- Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1) (2025):
- Efficacy and safety of co-administered cagrilintide and semaglutide for weight management in people with type 2 diabetes (2023):
- Cagrilintide Plus Semaglutide Phase 1b Trial (2021):
- Once-weekly cagrilintide for weight management in people with overweight or obesity: a phase 2 trial (2021):
- REDEFINE 2 Cagrilintide-Semaglutide Trial ():
Study Tables by Evidence Type
Human Studies & Clinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1) | 2025 | 3,417 adults with overweight/obesity | -20.4% weight change vs. -3.0% placebo (p<0.001); GI adverse events 79.6% vs. 39.9% placebo.
| ||
| Efficacy and safety of co-administered cagrilintide and semaglutide for weight management in people with type 2 diabetes | 2023 | 92 adults with type 2 diabetes | Combination (CagriSema) HbA1c -2.2pp, weight -15.6% vs. cagrilintide alone -0.9pp/-8.1%.
| ||
| Cagrilintide Plus Semaglutide Phase 1b Trial | 2021 | An early controlled Phase 1b study reported greater weight reduction with co-administered cagrilintide and semaglutide than with comparator arms in selected adults, including people with type 2 diabetes. Findings describe the combination and must not be attributed to cagrilintide monotherapy. | |||
| Once-weekly cagrilintide for weight management in people with overweight or obesity: a phase 2 trial | 2021 | 706 adults with overweight/obesity | 6.0-10.8% weight loss vs. 3.0% placebo; GI adverse events 41-63% vs. 32% placebo.
| ||
| REDEFINE 2 Cagrilintide-Semaglutide Trial | REDEFINE 2, a Phase 3a trial in adults with obesity and type 2 diabetes, reported significantly greater weight reduction with cagrilintide-semaglutide (CagriSema) than placebo in that population. The result applies to the exact combination product, escalation scheme, population, and duration studied -- not to cagrilintide monotherapy. |
Animal / Cell / Preclinical Data
No Animal / Cell / Preclinical Data Listed Yet
This section will be updated as sources are added.
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management | 2025 | N/A — regulatory filing announcement | Confirms a New Drug Application for CagriSema (cagrilintide + semaglutide) was submitted to the FDA in December 2025; decision expected in 2026. Cagrilintide is not FDA-approved as a standalone product. | ||
| FDA GSRS/UNII Cagrilintide Substance Record | FDA's Global Substance Registration System identifies cagrilintide (UNII AO43BIF1U8) as an amylin-analogue peptide substance. A UNII record establishes chemical/substance identity only and does not indicate FDA approval, safety review, or effectiveness determination. | ||||
| FDA Prime Sciences Warning Letter for Unapproved Cagrilintide and Mazdutide Products | FDA warning letter dated March 31, 2026 to Prime Sciences identifies U.S.-marketed cagrilintide and mazdutide products as unapproved new drugs and emphasizes the added public-health risks of injectable products that have not undergone FDA review for quality, safety, or effectiveness. | ||||
| REDEFINE 1 Trial Registry | Official ClinicalTrials.gov registry record for REDEFINE 1, describing cagrilintide-semaglutide (CagriSema) as an investigational combination not yet approved for prescribing. | ||||
| REDEFINE 3 Cardiovascular Outcomes Trial Registry | Official ClinicalTrials.gov registry record for REDEFINE 3, the dedicated cardiovascular-outcomes trial for cagrilintide-semaglutide. Cardiovascular-event-reduction benefit is not yet established pending this trial's results. |
Review Articles / Secondary Sources
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Innovation and therapeutic focus - Annual Report 2025 | 2025 | Novo Nordisk states that cagrilintide monotherapy is being advanced in the RENEW phase 3 program and cites REDEFINE 1 monotherapy data. This supports late-stage investigational status as of the research date, not approval. | |||
| Development of Cagrilintide, a Long-Acting Amylin Analogue | Current | Medicinal chemistry development review | Covers cagrilintide's chemical development. Full text was paywalled (403) beyond title/journal/DOI verification — do not cite specific findings from this source beyond that it exists and covers chemical development. |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Cagrilintide is investigational and not FDA-approved as a standalone product. Content here reflects published trial data only and is not a recommendation to use cagrilintide or any unapproved product.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Published. Last updated 2026-07-30.
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