Peptide guide
Cagrilintide: What the Evidence Actually Shows
Also called AM833, NNC0174-0833, Long-acting amylin analogue
Cagrilintide is an amylin analogue, and it is having a moment for a reason that has almost nothing to do with cagrilintide by itself. The figures attached to its name in search results — 20.4% weight loss at 68 weeks, 13.7% in type 2 diabetes — come from CagriSema, a fixed combination of cagrilintide with semaglutide, and the semaglutide half of that combination has its own 14.9% on record. What cagrilintide alone has published is a 26-week phase 2 dose-finding trial where the top dose reached 10.8%, plus comparator arms inside combination trials — 302 of 3,417 participants in one, 152 of 2,713 in another — whose reported endpoints are about the combination. The first phase 3 trial with cagrilintide alone as its subject was listed on ClinicalTrials.gov in August 2026 as active and not recruiting, with an estimated completion in June 2027. Here is what separates the two.
Phase 2
706assigned to cagrilintide
26weeks
Noneany indication
Compound
What it is
Cagrilintide is a long-acting analogue of amylin, a pancreatic hormone that induces satiety, developed for once-weekly subcutaneous injection in weight management. Its own dose-response relationship for effect on body weight, safety and tolerability was still the open question when its phase 2 trial began. It is also the amylin half of cagrilintide-semaglutide, a fixed combination with the GLP-1 receptor agonist semaglutide that has been tested at 2.4 mg of each and at 1.0 mg of each. Novo Nordisk funded every trial cited on this page.1,2,4
Mechanism
How it works
Amylin and GLP-1 are described as having complementary effects on glycaemic control and body weight, which is the stated rationale for combining an amylin receptor agonist with a GLP-1 receptor agonist in one weekly injection. Tested alone over 26 weeks, cagrilintide produced dose-dependent weight reduction ranging from 6.0% at 0.3 mg to 10.8% at 4.5 mg against 3.0% on placebo, and the 4.5 mg dose beat once-daily liraglutide 3.0 mg, which reached 9.0%. Tested as half of the combination in type 2 diabetes, the pairing lowered glycated haemoglobin by 1.91 percentage points at week 68 against 1.75 for semaglutide 2.4 mg alone — a difference of 0.16 percentage points.1,4
Evidence
What the trials found
Evidence strength: Early human. Small, open-label, or phase 1/2 trials. Promising, unproven.
The published trial with cagrilintide alone as its subject is a phase 2 dose-finding study at 57 sites in ten countries, which randomly assigned 706 participants to once-weekly cagrilintide at 0.3, 0.6, 1.2, 2.4 or 4.5 mg, 99 to once-daily liraglutide 3.0 mg and 101 to placebo, over a 26-week treatment period. The larger trials described below all test the combination. REDEFINE 1 randomized 3,417 adults with overweight or obesity and without diabetes in a 21:3:3:7 ratio to cagrilintide-semaglutide, semaglutide alone, cagrilintide alone, or placebo for 68 weeks, and reported −20.4% for the combination against −3.0% for placebo. REDEFINE 2 randomized 1,206 adults with type 2 diabetes 3:1 to the combination or placebo for 68 weeks: −13.7% against −3.4%. REIMAGINE 2 randomized 2,713 people with type 2 diabetes across six arms including cagrilintide 2.4 mg alone (152 participants), and its reported primary endpoint is the combination against semaglutide 2.4 mg on glycated haemoglobin. REIMAGINE 1 (189 participants) and REIMAGINE 3 (274 participants) tested the combination against placebo over 40 weeks in earlier-stage and insulin-treated type 2 diabetes respectively.1,2,3,4,5,6
10.8%
Weight loss, 4.5 mg alone — 26 wk
Phase 2 dose-finding trial, the highest dose tested, against 3.0% on placebo.
20.4%
Weight loss, combination — 68 wk
REDEFINE 1's cagrilintide-semaglutide arm — the combination, not cagrilintide alone.
Cagrilintide-alone weight result at 68 weeks
REDEFINE 1 assigned 302 of 3,417 participants to cagrilintide alone; its published abstract reports the combination-versus-placebo endpoints.
300
Enrolled in the first monotherapy phase 3
RENEW 1 (NCT07220642), estimated; active and not recruiting, estimated completion June 2027.
Weight change: what belongs to which product (%)
Trial size, participants randomized
How to read the evidence meter
How to read the evidence meter
Four steps, weakest to strongest. Most peptides sold for a goal light up one. We show the step the published human evidence actually reaches — not the step the seller implies.
- AnecdotalUser reports and forum consensus. No controlled data.
- Animal onlyRodent or cell studies. Nothing published in humans.
- Early humanSmall, open-label, or phase 1/2 trials. Promising, unproven.
- Randomized trialsRandomized controlled trials in humans, at scale.
Timeline
Development pipeline
- Complete
Preclinical
- Complete
Phase 1
- Complete
Phase 2
26-week dose-finding trial, 0.3 to 4.5 mg once weekly
- 4 — Current step
Phase 3 (as monotherapy)
RENEW 1 and a companion diabetes trial registered late 2025; estimated completion June 2027
- 5 — Not reached
FDA review & approval
No drugsFDA match, any indication
Summary
What the evidence does — and doesn't — support
Tested mostly as half of something else
- Dose-dependent weight reduction over 26 weeks in a randomized, placebo-controlled phase 2 trial
- A larger 26-week weight reduction at 4.5 mg than once-daily liraglutide 3.0 mg achieved in the same trial
- A role as the amylin component of a combination that reached 20.4% at 68 weeks in phase 3
- Adverse-event rates in a cagrilintide-alone phase 3 arm broadly in line with semaglutide's in the same trial
- The 20.4% figure as cagrilintide's own — that is the cagrilintide-semaglutide combination
- A quantified contribution of cagrilintide to the combination's effect
- Any weight result for cagrilintide alone beyond 26 weeks of published follow-up
- A dose carried forward from the best monotherapy result — phase 3 fixed 2.4 mg, not the 4.5 mg that performed best at 26 weeks
- A consumer supply chain — there is no FDA-approved cagrilintide product
Reality check
The catch
Dosing
Dosing evidence
The dose ladders belong to their trials and do not transfer. The phase 2 monotherapy trial tested 0.3, 0.6, 1.2, 2.4 and 4.5 mg once weekly with a dose-escalation period of up to six weeks; the highest weight reduction came from the highest dose tested, which means the top of the response curve was not established within that range. The phase 3 combination trials fixed the dose instead of exploring it: REDEFINE 1 and REDEFINE 2 used cagrilintide 2.4 mg with semaglutide 2.4 mg, and the REIMAGINE trials tested that pairing alongside a lower 1.0 mg-plus-1.0 mg pairing. So the 4.5 mg that produced the best monotherapy result at 26 weeks is not the dose the phase 3 programme carried forward. No dose on this page is a recommendation: each is what a named trial assigned to a randomized group.1,2,3,4,5,6
Already have a dose in mind? Our reconstitution calculator converts it to syringe units. It does not suggest one.
Safety
Safety and side effects
Gastrointestinal disorders were the most frequent adverse events in the phase 2 monotherapy trial, alongside administration-site reactions: 41% to 63% of the cagrilintide dose groups reported gastrointestinal events against 32% on placebo, with nausea in 20% to 47% against 18%. Permanent treatment discontinuation occurred in 73 participants, reported as 10%, distributed similarly across treatment groups, 30 of them due to adverse events. In the combination trials the gastrointestinal burden is larger and belongs to the pairing rather than to cagrilintide alone: 79.6% against 39.9% on placebo in REDEFINE 1, and 72.5% against 34.4% in REDEFINE 2, mainly transient and mild to moderate. REIMAGINE 2 reported adverse events in 125 of 152 participants (82.2%) in its cagrilintide 2.4 mg arm, against 105 of 149 (70.5%) on placebo and 491 of 605 (81.2%) on semaglutide 2.4 mg. REIMAGINE 3 recorded no severe hypoglycaemia and one death, in a combination arm, judged unrelated to treatment and due to malignancy.1,2,3,4,6
Sold for laboratory use. Not a legal medicine for people.
The subtraction the published record does not supply
Put the three published figures side by side and the question answers itself. Cagrilintide alone, top dose, 26 weeks: 10.8% 1. Semaglutide alone, 2.4 mg, 68 weeks: 14.9%, from a separate trial on our semaglutide page. The combination, 68 weeks: 20.4% 2. Those are different trials at different durations in different cohorts, so subtracting one from another does not yield cagrilintide's contribution — that is exactly the arithmetic the cagrilintide-alone arm of REDEFINE 1 was built to supply, and the arm's weight result is not in the trial's published abstract 2. Until it is read alongside the combination, "cagrilintide works" and "cagrilintide adds something to semaglutide" are two different claims with different amounts of evidence behind them.
What the registry shows about where this is going
As of August 2026 a ClinicalTrials.gov search for cagrilintide returns 43 studies, and the phase 3 records are overwhelmingly CagriSema studies — REDEFINE, REIMAGINE, and comparisons against tirzepatide and semaglutide. Two phase 3 records list cagrilintide alone as the treatment: RENEW 1 (NCT07220642), 300 participants estimated, primary endpoint relative body-weight change at week 64, active and not recruiting, estimated completion June 2027; and a companion record in people with type 2 diabetes (NCT07220759), 330 estimated, estimated completion June 2027. Both were registered in late 2025 — years after the combination programme started. That ordering is the story: the combination was taken to scale first, and the dedicated monotherapy question is being answered afterwards.
Why "amylin" is not a shortcut
Amylin analogues are being written about as a new mechanism, and cagrilintide is the compound the label gets attached to. The published mechanism claim is narrower than that framing. Amylin is described as a pancreatic hormone that induces satiety and cagrilintide as a long-acting analogue under investigation for weight management 1; the pairing with semaglutide is described as complementary on glycaemic control and body weight 4. A hormone class with a plausible rationale and one published 26-week monotherapy trial is an early-stage answer, whatever the combination's phase 3 numbers look like.
No approved product, and what that means here
A drugsFDA search returns no match for cagrilintide. There is therefore no approved label, no approved dose, no approved manufacturer, and no pharmacy that can dispense it. Nothing on this page tells you where to obtain it, because for an unapproved molecule that would be a description of the grey market rather than a fact about the compound. The same rule governs our retatrutide page, for the same reason.
Questions
Frequently asked questions
Is cagrilintide the same as CagriSema?
No. CagriSema is a fixed combination of cagrilintide with semaglutide, tested at 2.4 mg of each and at 1.0 mg of each. The widely quoted figures — −20.4% at 68 weeks in REDEFINE 1, −13.7% in REDEFINE 2 — are combination results. Cagrilintide on its own has one published dose-finding phase 2 trial, at 26 weeks.
How much weight does cagrilintide alone cause?
In the 26-week phase 2 dose-finding trial, mean weight reductions ranged from 6.0% at 0.3 mg to 10.8% at 4.5 mg once weekly, against 3.0% on placebo; the 4.5 mg dose also beat once-daily liraglutide 3.0 mg, which reached 9.0%. Larger trials have included cagrilintide-alone arms — 302 participants in REDEFINE 1, 152 in REIMAGINE 2 — but the endpoints reported in their published abstracts concern the combination.
Is cagrilintide FDA-approved?
A drugsFDA search returns no match for cagrilintide, for any indication, as of August 2026. There is no approved label, no approved manufacturer and no approved dose. The first phase 3 trial with cagrilintide alone as its subject, RENEW 1, was listed on ClinicalTrials.gov in August 2026 as active and not recruiting with an estimated completion of June 2027.
What dose of cagrilintide was studied?
The phase 2 trial assigned 0.3, 0.6, 1.2, 2.4 or 4.5 mg once weekly after an escalation period of up to six weeks. The phase 3 combination trials fixed cagrilintide at 2.4 mg or at 1.0 mg alongside a matching semaglutide dose. Those are trial assignments, not recommendations — and note that the best monotherapy result came from 4.5 mg, which is not the dose the phase 3 programme carried forward.
What are cagrilintide's side effects?
In the monotherapy phase 2, gastrointestinal disorders and administration-site reactions were the most frequent adverse events, with gastrointestinal events in 41% to 63% of cagrilintide dose groups against 32% on placebo and nausea in 20% to 47% against 18%. About 10% of participants discontinued permanently, distributed similarly across groups. In the combination trials the gastrointestinal rates are higher — 79.6% in REDEFINE 1 and 72.5% in REDEFINE 2 — but those belong to the pairing with semaglutide, not to cagrilintide alone.
Glossary
Key terms
- Amylin analogue
- A drug built to mimic amylin, a pancreatic hormone described in the trial literature as inducing satiety. A different target from GLP-1.
- Fixed-dose combination
- Two active drugs in one injection at set amounts. Its results belong to the pair, not to either component on its own.
- Dose-finding trial
- An early trial testing several doses to map the response curve. When the best result is at the highest dose tested, the top of the curve is still unknown.
- Comparator arm
- A trial group receiving something other than the drug under test — here, cagrilintide alone inside trials designed to answer a question about the combination.
- Active-controlled
- A trial that includes a working drug as a control, such as the liraglutide 3.0 mg arm in cagrilintide's phase 2, alongside or instead of placebo.
Sources
References
- Lau DCW, Erichsen L, Francisco AM, et al. (2021). Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. The Lancet. https://pubmed.ncbi.nlm.nih.gov/34798060/
- Garvey WT, Blüher M, Osorto Contreras CK, et al. (2025). Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine. https://pubmed.ncbi.nlm.nih.gov/40544433/
- Davies MJ, Bajaj HS, Broholm C, et al. (2025). Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. New England Journal of Medicine. https://pubmed.ncbi.nlm.nih.gov/40544432/
- Buse JB, Bajaj HS, Dalskov SM, et al. (2026). Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study. The Lancet Diabetes & Endocrinology. https://pubmed.ncbi.nlm.nih.gov/42251859/
- Aroda VR, Buzzetti R, Dalskov SM, et al. (2026). Efficacy and safety of once-weekly cagrilintide-semaglutide (CagriSema) in adults with type 2 diabetes inadequately controlled on diet and exercise (REIMAGINE 1): a randomised, double-blind, placebo-controlled, phase 3a study. The Lancet Diabetes & Endocrinology. https://pubmed.ncbi.nlm.nih.gov/42251860/
- Rosenstock J, Billings LK, Gajria R, et al. (2026). Cagrilintide-semaglutide (CagriSema) as an add-on to basal insulin in adults with type 2 diabetes (REIMAGINE 3): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. The Lancet. https://pubmed.ncbi.nlm.nih.gov/42251856/
Medical disclaimer: This content is for general educational purposes only and is not medical advice, diagnosis, or treatment. Always consult a licensed healthcare professional before starting, stopping, or changing any treatment.