Cagrilintide: the complete research guide.

Cagrilintide is a once-weekly synthetic amylin analog, and the partner peptide in CagriSema, Novo Nordisk's next-generation obesity drug. Phase 2 monotherapy reported 9.7% mean body-weight reduction. With semaglutide, the pair reached 20.4% at 68 weeks in REDEFINE-1. It isn't FDA-approved as of May 2026.

What cagrilintide actually is

Cagrilintide is a 37-amino-acid synthetic analog of human amylin, the pancreatic hormone co-secreted with insulin in response to a meal. Novo Nordisk introduced a fatty-acid acyl chain into the structure. That chain binds albumin in circulation, which extends the molecule's half-life and converts it from a short-acting peptide into a once-weekly dosing candidate.

Native amylin presents two pharmacological challenges. It clears from circulation within minutes, and it tends to aggregate into amyloid fibers. That's the same aggregation associated with type 2 diabetes pathology. Cagrilintide's structural engineering addresses both. Getting there took roughly two decades of medicinal chemistry.

The development program runs two ways. Standalone cagrilintide is one track. The other and more prominent track is CagriSema, a fixed-dose pairing with semaglutide. The combination has bigger Phase III numbers, so that's where the regulatory attention has gone, and where most of our attention goes here.

How it works

Amylin receptor binding

Cagrilintide binds the same central and peripheral receptors engaged by native amylin. Preclinical and clinical studies have reported slowed gastric emptying, reduced caloric intake, and attenuated post-prandial hepatic glucose output consistent with amylin receptor activation.

It complements GLP-1

The rationale for co-administration with semaglutide rests on the fact that amylin and GLP-1 engage satiety through overlapping but distinct brain circuits. A 2024 review by Melson and colleagues at the University of Leicester characterized the complementary pathway architecture. Engaging both produced additive rather than redundant satiety signaling in trial populations.

Acylation and extended half-life

The fatty-acid modification in cagrilintide serves the same pharmacokinetic function as in semaglutide and tirzepatide. Reversible albumin binding extends the molecule's circulation time, enabling once-weekly dosing. Acylation has become the established engineering approach for converting fast-clearing peptides into long-acting therapeutics.

Dosing in clinical trials

Trial doses range from 0.3 mg to 4.5 mg weekly as monotherapy. In CagriSema, the dose is locked at 2.4 mg paired with 2.4 mg of semaglutide.

• Phase 2 monotherapy (Lau 2021): weekly subcutaneous doses of 0.3, 0.6, 1.2, 2.4, and 4.5 mg, starting at 0.3 mg and titrating up every four weeks. Compared against liraglutide 3.0 mg daily.
• REDEFINE-1 Phase III (Garvey 2025): cagrilintide 2.4 mg weekly, alone or with semaglutide 2.4 mg. 16-week titration, 68-week treatment.
• REDEFINE-2 (Davies 2025): same dosing in adults with type 2 diabetes and BMI 27 or higher.

The phased titration was protocol-specified in both the Phase 2 and REDEFINE-1 trials. Investigators noted that step-wise escalation was required to keep gastrointestinal adverse events within manageable bounds. It's the same titration rationale documented across semaglutide and tirzepatide trial designs.

Body-weight-reduction time course in trials

Published trial data reported a characteristic trajectory for cagrilintide across study arms. It matches the pattern seen in other long-acting incretin and amylin agents.

• Weeks 1–4 (titration phase): mean body-weight reduction of approximately 1–3% reported. Gastrointestinal adverse events peaked during this interval in trial data.
• Weeks 4–12: progressive body-weight reduction of approximately 4–7% as participants approached maintenance dose. GI event rates plateaued per trial reporting.
• Weeks 12–26: continued loss reaching approximately 9.7% at 26 weeks in Phase 2 monotherapy (4.5 mg arm, Lau et al., 2021).
• Weeks 26–68: attenuating rate of change. REDEFINE-1 reported cagrilintide monotherapy reaching ~11% and CagriSema reaching 20.4% at 68 weeks (Garvey et al., 2025).

Cagrilintide standalone — catalog roadmap

37 aa Acylated amylin Once-weekly

Cagrilintide standalone is on our catalog roadmap as Novo Nordisk advances through FDA review. For research on the multi-mechanism obesity class today, our closest stocked alternatives are retatrutide (the triple agonist from Eli Lilly's TRIUMPH program) and tirzepatide (the FDA-approved dual agonist). Both ship with batch-matched CoAs from ISO 17025 third-party labs.

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Administration in clinical trials

Route and sites

In all published trials, cagrilintide was administered as a once-weekly subcutaneous injection. The REDEFINE-1 protocol specified rotation across standard subcutaneous sites: abdomen, thigh, upper arm. The third-party tested compound requires reconstitution. Novo Nordisk's anticipated commercial product should ship pre-formulated in an auto-injector.

Dose titration protocol

REDEFINE-1 used a 16-week titration schedule, escalating roughly every four weeks to reach the 2.4 mg maintenance dose. The Phase 2 trial by Lau and colleagues in 2021 also started at 0.3 mg with staged up-titration.

Investigators put the need for titration down to gastrointestinal tolerability. Adverse event rates ran markedly higher in earlier studies where titration was compressed.

CagriSema co-administration in REDEFINE-1

In REDEFINE-1, study participants in the CagriSema arm received cagrilintide 2.4 mg and semaglutide 2.4 mg as two separate subcutaneous injections administered on the same weekly schedule. Novo Nordisk has disclosed development of a co-formulated single-injection device, though this has not been reported in published trial data as of May 2026.

Research evidence summary

The evidence base here is unusual. Most peptides we cover have rodent papers and a handful of small human studies. Cagrilintide has two completed Phase III trials in NEJM, a Phase 2 trial in The Lancet, and a meta-analysis. We'd call that genuine pharmaceutical-grade evidence.

Phase 2 monotherapy — the Lau trial (2021)

The Phase 2 trial ran 26 weeks in 706 adults with obesity. Doses were 0.3, 0.6, 1.2, 2.4 and 4.5 mg weekly, plus liraglutide 3.0 mg as an active comparator and a placebo arm.

The headline: the highest cagrilintide dose hit 9.7% mean body-weight reduction, against 9.0% with liraglutide and 3.0% with placebo. The response was dose-dependent across all cagrilintide arms.

REDEFINE-1 — CagriSema in obesity without diabetes

REDEFINE-1 was a 68-week Phase III trial in 3,417 adults. Four arms: CagriSema, semaglutide alone, cagrilintide alone, and placebo. The CagriSema arm reported 20.4% mean body-weight reduction versus 3.0% for placebo. A significantly greater proportion of CagriSema study participants reached body-weight-reduction thresholds of 5%, 20%, 25%, and 30% compared with placebo.

REDEFINE-2 — CagriSema in type 2 diabetes

REDEFINE-2 investigated the same combination in 1,206 adults with type 2 diabetes. Mean weight change was −13.7% versus −3.4% with placebo. The glycemic endpoint was the primary headline: 73.5% of CagriSema study participants reached HbA1c at or below 6.5% versus 15.9% on placebo.

Meta-analysis

A 2024 systematic review by Dutta and colleagues aggregated the cagrilintide and CagriSema trials. Two findings stood out to us. The combination beat semaglutide alone by roughly 9 additional percentage points of body-weight reduction. And cagrilintide monotherapy showed significantly less vomiting than GLP-1 monotherapy, which suggests the high GI rate in CagriSema mostly comes from the semaglutide side.

CagriSema: dual-mechanism rationale

CagriSema is a fixed-dose pharmaceutical combination, not a self-assembled research protocol. The combination's pharmacological rationale is extensively documented in the trial literature, and we think it shows how the dual-mechanism incretin/amylin class operates.

Two satiety circuits. GLP-1 acts on hindbrain and hypothalamic satiety pathways. Amylin acts on overlapping but functionally distinct circuits within the same regions. Studies have reported additive rather than redundant satiety signaling when both pathways are engaged simultaneously.

Different tolerability profiles. The Dutta meta-analysis found cagrilintide monotherapy was associated with significantly less vomiting than GLP-1 monotherapy. This finding suggests cagrilintide monotherapy may represent a relevant research comparator for study cohorts in whom GLP-1 tolerability is a limiting factor.

Adjacent comparisons. The other multi-mechanism obesity drugs follow the same playbook: retatrutide, mazdutide and survodutide. We compare them all in our 2026 class comparison.

Side effects in trials

Commonly reported

• GI symptoms — nausea, vomiting, diarrhea, constipation, abdominal pain. 79.6% of CagriSema study participants in REDEFINE-1 reported some gastrointestinal symptom versus 39.9% on placebo. Trial reporting described most events as transient and mild-to-moderate.
• Injection-site reactions — redness, pain, or itching at the injection site, reported across trial arms.
• Reduced appetite and early satiety — consistent with the compound's amylin receptor mechanism; reported as an anticipated pharmacodynamic effect in trial documentation.

Less commonly reported

• Hypoglycemia — reported particularly in REDEFINE-2 study participants on background insulin or sulfonylureas. Rare in non-diabetic trial populations.
• Fatigue and dizziness — associated in trial reporting with the rate of body-weight reduction.
• Cholelithiasis — a class-level effect documented across rapid-body-weight-reduction pharmacotherapies.

Rare but serious

• Pancreatitis — theoretical class concern.
• Severe gallbladder disease — documented across the rapid-body-weight-reduction class.
• Allergic reactions — rare but reported across long-acting peptide products.

Legal status and FDA approval

As of May 2026:

• FDA (US): not approved as standalone or as CagriSema. Phase III is complete. Novo Nordisk filing is anticipated.
• EMA (EU): not approved.
• Pramlintide context: the short-acting amylin analog pramlintide (brand name Symlin) got FDA approval in 2005 as an insulin adjunct for diabetes. It's a different molecule, requires three to four shots a day, and isn't approved for the obesity indication.

Cagrilintide can be sold legally in the US as a research compound labeled for laboratory use only. Selling or marketing it for human therapeutic use is not legal before approval. You should also know that Novo Nordisk holds active patents on the molecule and its manufacturing chain.

Sports and WADA status

Cagrilintide hasn't been listed by name on the WADA Prohibited List. Two categories could apply on review:

• S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics) — as a peptide hormone analog, cagrilintide falls within S2's scope.
• S4 (Hormone and Metabolic Modulators) — the satiety and gastric-emptying effects also fit S4.

Check the current WADA Prohibited List directly for the authoritative categorization. Treat any unapproved investigational compound as high-risk for an inadvertent anti-doping violation if you're tested, whatever its formal status.

Closest stocked alternatives

Retatrutide 10 mg Tirzepatide 10 mg ≥99% pure

Standalone cagrilintide is on the catalog roadmap pending FDA review. For multi-mechanism obesity research today, the closest compounds in our catalog are retatrutide (Phase III triple agonist) and tirzepatide (FDA-approved dual agonist). Same pharmacological neighborhood. CoA available with each lot.

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Frequently asked questions

What is cagrilintide?

Cagrilintide is a long-acting synthetic analog of amylin, the pancreatic hormone co-secreted with insulin in response to meals. Novo Nordisk engineered it for once-weekly subcutaneous dosing using fatty-acid acylation.

The two main development tracks are standalone monotherapy and the CagriSema fixed-dose combination with semaglutide. Neither has FDA approval as of May 2026, though two Phase III trials are published and a regulatory filing is anticipated.

How is cagrilintide different from CagriSema and from semaglutide?

These are three distinct entities. Cagrilintide is a single molecule, a long-acting amylin analog. Semaglutide is a separate molecule, a long-acting GLP-1 analog approved as Wegovy and Ozempic. CagriSema is the fixed-dose combination of both.

REDEFINE-1 reported the combination at 20.4% mean body-weight reduction, semaglutide alone at roughly 15%, and cagrilintide alone at roughly 11%. The combination beat either monotherapy arm on all pre-specified body-weight endpoints.

Is cagrilintide FDA-approved?

No. Neither standalone cagrilintide nor the CagriSema combination has received FDA approval as of May 2026. Phase III trial evidence has been published in NEJM. The molecule remains pre-approval and is sold in the US only as a research reference compound labeled for laboratory use only.

What does the monotherapy trial data show?

The Phase 2 trial by Lau and colleagues in 2021 tested doses from 0.3 to 4.5 mg weekly, against liraglutide 3.0 mg and placebo, over 26 weeks.

The 4.5 mg arm reported approximately 9.7% mean body-weight reduction. That's comparable to liraglutide's 9.0%, but with significantly less vomiting. In REDEFINE-1 at 68 weeks, the cagrilintide monotherapy arm reported approximately 11%.

How much does cagrilintide cost for research procurement?

No legitimate pharmacy price exists, because no standalone product has been approved. third-party tested vials from various suppliers in 2026 have listed at roughly $72–$200 per 5–10 mg vial, depending on purity tier and supplier.

Given the synthesis complexity of a 37-amino-acid acylated peptide, anything much below $60 per 5 mg vial should send you to independent identity and purity verification. Novo Nordisk's pharmaceutical-grade pricing on approval is expected in the Wegovy range, above $1,300 a month without insurance.

Where can research institutions source it?

Standalone cagrilintide is on the catalog roadmap pending Novo Nordisk's FDA review. For research on the multi-mechanism obesity class, the closest available alternatives are retatrutide, the GIP/GLP-1/glucagon triple agonist, and tirzepatide, the FDA-approved dual agonist.

When you evaluate any supplier, verify three specifications. HPLC purity at 98% or better. Mass-spectrometric confirmation of the acylated 37-residue molecule. And a CoA from an ISO/IEC 17025-accredited third-party laboratory.

How is cagrilintide different from pramlintide (Symlin)?

Both are amylin analogs, but they differ substantially in pharmacokinetics and clinical use. Pramlintide, FDA-approved as Symlin in 2005, is short-acting and needs an injection with each meal, typically three or four a day. It's approved as a diabetes adjunct to insulin.

Cagrilintide is a long-acting, fatty-acid-acylated formulation designed for once-weekly dosing, developed mainly for obesity rather than glycemic control. The acylation engineering, and the half-life extension it buys, is the key structural and clinical distinction.