cagrilintide

novo's long-acting amylin analog. 11.8% standalone weight loss in the phase-3 REDEFINE-1 trial (10.8% earlier in phase 2). the filed product is the cagrisema combo, not the monotherapy.

tier B · weight loss · 10.8% Lau 2021 phase 2

verdict

a long-acting amylin analog from novo. the standalone hit 11.8% weight loss in the phase-3 REDEFINE-1 trial (10.8% in phase 2 before that). the program novo actually filed with the FDA is the cagrisema combo, not cagrilintide alone.

if you're asking whether cagrilintide works on its own — as a monotherapy, the phase 2 dose-finding trial (Lau 2021, Lancet, 706 participants across 10 countries) showed dose-dependent weight loss from 6.0% to 10.8% over 26 weeks, and the top dose beat liraglutide 3.0 mg in the same trial (10.8% vs 9.0%, P=0.03). a standalone phase 3 program (RENEW) is underway. that is a real, single-mechanism signal. it is not approved, and the deeper combo numbers belong to cagrisema, not to cagrilintide by itself.

if you're asking why people talk about cagrilintide and cagrisema together — cagrisema is the fixed-dose combination of semaglutide plus cagrilintide. that combination is the program novo filed with the FDA (NDA December 2025, under review). the deeper combo weight-loss figures come from that two-drug product. attributing the combo result to cagrilintide alone overstates what the monotherapy has shown. on its own, the phase 2 ceiling was 10.8%.

if you're asking about gray-market cagrilintide — as a standalone, cagrilintide is investigational and not FDA-approved. lawful US pharmacy access to the monotherapy does not exist before approval. vendor 'cagrilintide' is gray-market research supply with no identity, purity, or dose-response data backing the dose used in gray-market practice. the amylin mechanism is real and the phase 2 data is real, but the gray-market vial is not the trial product.

based on published evidence and disclosed clinical practice. not medical advice. dose and protocol conversations belong with a clinician.

why B-tier

B-tier because the standalone is investigational and its strongest published number (11.8% in the phase-3 REDEFINE-1 trial) trails the FDA-grade obesity drugs. the mechanism is real and the data is real, including a within-trial win over liraglutide in phase 2. but the program that reached an FDA filing is the cagrisema combination, not the monotherapy, and the dedicated RENEW monotherapy phase-3 is still running. S is reserved for approved or dominant-evidence compounds; A is reserved for compounds in wide clinical use. cagrilintide alone is neither yet.

the core tension

the second mechanism behind the cagrisema story, standing on its own. as a monotherapy cagrilintide hit 11.8% weight loss in the phase-3 REDEFINE-1 trial (10.8% earlier in phase 2) and beat daily liraglutide head-to-head, a real signal for a single-mechanism amylin analog. but the program that reached an FDA filing is the combination with semaglutide, not the standalone, and the dedicated RENEW monotherapy phase-3 is still running. B-tier because the monotherapy is unapproved and its strongest numbers belong to the combo, not to cagrilintide alone.

what it is

a 37-amino-acid long-acting amylin analog from Novo Nordisk. amylin is a pancreatic hormone co-secreted with insulin that signals meal-related satiety through the area postrema. native amylin lasts minutes; cagrilintide is acylated to extend the half-life to roughly a week, enabling once-weekly subcutaneous dosing. the standalone is investigational. the product novo filed with the FDA is the fixed-dose combination with semaglutide, marketed in trials as cagrisema.

what it does

binds amylin and calcitonin receptors in the area postrema and reinforces meal satiety, distinct from the GLP-1 pathway. as a monotherapy in the phase 2 dose-finding trial (Lau 2021, Lancet), cagrilintide produced dose-dependent weight loss from 6.0% at the lowest dose to 10.8% at 4.5 mg over 26 weeks. the 4.5 mg arm beat liraglutide 3.0 mg (10.8% vs 9.0%, P=0.03) in the same study. a standalone phase 3 program (RENEW) is now testing the monotherapy.

origin

Novo Nordisk's amylin program, the long-acting successor to pramlintide (the short-acting amylin analog Symlin). the phase 2 dose-finding trial published in the Lancet in 2021 (Lau et al., 706 participants across 10 countries). cagrilintide then became the amylin half of the cagrisema combination, which ran through the REDEFINE phase 3 program and reached an NDA filing in December 2025. a standalone phase 3 program (RENEW) is evaluating cagrilintide on its own.

why researchers are interested

a second appetite mechanism that isn't another GLP-1. amylin signaling reinforces satiety through a pathway GLP-1 drugs don't touch, which is why pairing the two (in cagrisema) outperformed either alone. for readers tracking the next layer of obesity pharmacology, cagrilintide is the standalone version of that second mechanism, with a phase 2 number (10.8%) that already edged out daily liraglutide.

does it work

the standalone signal is real, with limits. in the phase-3 REDEFINE-1 trial cagrilintide 2.4 mg monotherapy cut weight 11.8% at 68 weeks (vs 2.3% placebo), and the earlier phase 2 dose-finding trial showed up to 10.8% at 26 weeks and beat liraglutide 3.0 mg in the same study. that is a genuine single-mechanism result for an amylin analog. the caveats: the standalone is not approved (the dedicated RENEW monotherapy phase-3 is still running), and the deeper weight-loss numbers people cite come from the cagrisema combination, not from cagrilintide alone. as a standalone it is investigational, with no FDA-reviewed label and no lawful US pharmacy access before approval. promising as a second mechanism, not yet proven as a solo drug, and not the same thing as the filed combo.

claims vs the data

• 10.8% mean weight loss as a standalone (phase 2) — supported — Lau et al., Lancet 2021 dose-finding trial (n=706, 10 countries). Dose-dependent weight loss from 6.0% to 10.8% over 26 weeks; 4.5 mg arm reached 10.8%.
• beat liraglutide as a standalone — supported — In the same phase 2 trial, cagrilintide 4.5 mg (10.8%) was superior to liraglutide 3.0 mg (9.0%), P=0.03. A within-trial comparison, not a separate head-to-head.
• produces cagrisema-level weight loss on its own — contradicted — The deeper combo figures belong to cagrisema (semaglutide + cagrilintide), not the monotherapy. Standalone cagrilintide's strongest published number is 10.8% at 26 weeks.
• a novel second mechanism beyond GLP-1 — supported — Amylin and calcitonin receptor agonism in the area postrema is a satiety pathway distinct from GLP-1, which is why combining the two outperformed either alone in REDEFINE 1.
• FDA-approved or filed as a standalone — contradicted — The December 2025 NDA is for the cagrisema combination, not standalone cagrilintide. The monotherapy is in phase 3 (RENEW) with no approval decision.
• well-tolerated — partially true — Phase 2 side effects were primarily gastrointestinal and generally mild-to-moderate, but the full standalone safety profile awaits completion of the phase 3 program.

key facts

• molecular formula: C₁₉₄H₃₁₂N₅₄O₅₉S₂
• molecular weight: ~4409 Da
• amino acids: 37
• half-life: ~7 days (once-weekly dosing)
• type: long-acting amylin (and calcitonin) receptor agonist
• CAS: 1415456-99-3
• 10.8% weight loss at 4.5mg, 26wk (phase 2)
• 9.0% liraglutide comparator, same trial
• 706 phase 2 participants (10 countries)
• phase 3 standalone program (RENEW), ongoing

frequently asked questions

What is cagrilintide?

Cagrilintide is a long-acting amylin analog developed by Novo Nordisk. Amylin is a pancreatic hormone that signals meal-related satiety; cagrilintide is engineered for once-weekly subcutaneous dosing. It is best known as the amylin half of the cagrisema combination, but it is also an investigational standalone agent.

What does cagrilintide do?

Cagrilintide activates amylin and calcitonin receptors in the area postrema to reinforce meal-related satiety, a mechanism distinct from GLP-1 drugs. In the phase 2 dose-finding trial (Lau 2021, Lancet), cagrilintide as a standalone produced dose-dependent weight loss up to 10.8% at 26 weeks, and the top dose beat liraglutide 3.0 mg in the same trial.

How is cagrilintide typically administered?

Cagrilintide is administered as a once-weekly subcutaneous injection in clinical trials, with the dose reached by stepwise titration. It is not commercially available as a standalone; any final dosing would be determined by regulatory review of the standalone program.

What are the side effects of cagrilintide?

Reported side effects in trials are primarily gastrointestinal, nausea, vomiting, and decreased appetite, consistent with amylin-pathway pharmacology. In the phase 2 trial these were generally mild-to-moderate. The full standalone safety profile is pending completion of the phase 3 program.

Is cagrilintide FDA approved?

No. As a standalone, cagrilintide is investigational and in phase 3 trials (RENEW). The FDA filing belongs to the cagrisema combination (semaglutide + cagrilintide), filed in December 2025 and under review; the monotherapy itself has no approval decision.

How is cagrilintide different from cagrisema?

Cagrilintide is the standalone amylin analog. Cagrisema is the fixed-dose combination of cagrilintide plus semaglutide. The deeper weight-loss figures often quoted belong to the combination; on its own, cagrilintide's strongest published number is the 10.8% phase 2 result.

How much does cagrilintide cost?

Cagrilintide is not commercially available as a standalone; no retail price exists. Any vendor versions are gray-market research supply, not equivalent to Novo's clinical product and not a pharmacy workaround.

related peptides

• cagrisema — the semaglutide + cagrilintide combo; the program novo actually filed
• semaglutide — the GLP-1 paired with cagrilintide in cagrisema
• liraglutide — the comparator cagrilintide beat in its phase 2 trial
• retatrutide — competing next-gen weight-loss molecule in phase 3

reptides grades the research record and cites the literature behind every call. research reference only; not medical advice.