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Cagrilintide

Cagrilintide (AM833 / NNC0174)

An investigational long-acting amylin analogue from Novo Nordisk. It is the amylin component of CagriSema and is now in a dedicated Phase 3 monotherapy program.

Reviewed August 15, 2026·11 min read·10 citations·Not approvedAmylin analogue
On this page

At a glance

Cagrilintide is a long-acting amylin analogue from Novo Nordisk. It is not a GLP-1 drug. It matters because amylin has become one of the main "beyond GLP-1" obesity mechanisms, both as a standalone pathway and as the amylin half of CagriSema.

Animal studiesStrongExtensive preclinical

Cagrilintide was selected through a published medicinal chemistry program and is supported by preclinical amylin-receptor biology.

Human evidenceModerate800+ direct subjects

Standalone cagrilintide has Phase 2 dose-finding data and a Phase 3 REDEFINE 1 monotherapy arm (11.8% weight loss vs. 2.3% placebo at 68 weeks, trial-product estimand). A dedicated Phase 3 monotherapy programme is running, but no pivotal standalone results have been reported.

Safety dataModeratePhase 1-3 exposure

Most adverse events are gastrointestinal or injection-site related. No approved-product post-marketing dataset exists.

How are these scores calculated?

New research, delivered clearly

When new studies publish or clinical trials report results, we'll break them down in plain language.

Quick facts

Class
Long-acting amylin analogue
Developer
Novo Nordisk
Amino acids
37 (modified amylin analogue)
Molecular weight
~4,409 Da
FDA status
Not approved
Program
Phase 3 monotherapy (NCT07220642 / NCT07220759)

Amino acid sequence

Long-acting acylated human amylin analogue

What is cagrilintide?

Cagrilintide is an investigational analogue of amylin, a hormone co-secreted with insulin by pancreatic beta cells. Natural amylin helps regulate satiety and post-meal glucagon, but it is hard to turn into a convenient drug because native amylin can aggregate and has a short useful exposure window.[2]

Novo Nordisk engineered cagrilintide to be more stable and long-acting. In practical terms, the program asks whether amylin can become for obesity what GLP-1 became over the last decade: a druggable gut-pancreas-brain signal that changes food intake in a clinically meaningful way.

Cagrilintide is also the amylin component of CagriSema. That combination evidence is important, but this profile focuses on cagrilintide itself: what the standalone data show, what the combination data imply, and what remains unknown.

How it works

Cagrilintide activates amylin-family receptors involved in satiety signaling. The clinical goal is not to mimic GLP-1; it is to add a different appetite-regulation pathway.

Mechanism details

Amylin is part of the calcitonin peptide family. Functional amylin receptors are formed from calcitonin receptors plus receptor activity-modifying proteins. Cagrilintide is designed to activate this receptor family while avoiding the aggregation problems that limit native amylin as a drug candidate.[2]

In obesity pharmacology, the key effects are:

  • Increased satiety and reduced food intake.
  • Slower gastric emptying and altered post-meal signaling.
  • Suppression of inappropriate glucagon secretion.
  • Complementarity with GLP-1 receptor agonism, as seen in CagriSema.

What the research says

Cagrilintide is no longer just a supporting actor for semaglutide. Two dedicated Phase 3 monotherapy trials are running, and Novo has guided to starting a further high-dose Phase 3 in late 2026 — amylin on its own is now a serious clinical development path. What does not yet exist is a single standalone Phase 3 result.

Peptide Garden evidence assessment, August 2026

Research timeline

  1. 2021Human study

    Medicinal chemistry and Phase 2 dose-finding published

    Novo's development paper described the long-acting amylin analogue design; a Lancet Phase 2 trial showed dose-dependent weight loss.

  2. 2023Human study

    CagriSema Phase 2 diabetes data

    Cagrilintide was tested alone and with semaglutide in type 2 diabetes, supporting the additive amylin + GLP-1 rationale.

  3. 2025Human study

    REDEFINE 1 monotherapy signal

    Cagrilintide 2.4 mg monotherapy showed 11.8% weight loss versus 2.3% placebo at 68 weeks under the trial-product estimand.

  4. 2026Human study

    Dedicated Phase 3 monotherapy underway

    Two Phase 3 cagrilintide monotherapy trials started in November 2025 — NCT07220642 in overweight/obesity (300 participants) and NCT07220759 in overweight/obesity with type 2 diabetes (330 participants) — and both are now closed to recruitment. Novo's August 2026 investor materials add a high-dose Phase 3 initiation guided for Q4 2026, plus a registered Phase 3 comparing two injectable formulations. No standalone Phase 3 results have been reported.

Key clinical trials

2021·Multicenter, randomized, double-blind, placebo- and active-controlled·n=706High quality

Phase 2 dose-finding — once-weekly cagrilintide

Overweight or obesity without diabetes

Cagrilintide produced dose-dependent weight loss from 6.0% to 10.8% at 26 weeks versus 3.0% with placebo.

2023·Multicenter, randomized, double-blind, active-controlled·n=92Moderate quality

Phase 2 type 2 diabetes — cagrilintide with and without semaglutide

Type 2 diabetes with overweight or obesity

Cagrilintide monotherapy produced weight loss but weaker glycemic effects than the CagriSema combination, clarifying its role as the amylin component.

2025·Phase 3a monotherapy arm within CagriSema obesity trial·n=302Moderate quality

REDEFINE 1 monotherapy arm

Obesity or overweight without diabetes

Novo reported 11.8% mean body-weight reduction with cagrilintide 2.4 mg versus 2.3% with placebo at 68 weeks under the trial-product estimand.

What the evidence shows

Does cagrilintide cause weight loss by itself?

Yes, but pivotal standalone confirmation is still pending. Phase 2 showed dose-dependent weight loss up to 10.8% at 26 weeks, and the REDEFINE 1 monotherapy arm reported 11.8% at 68 weeks.

Well-supported

Is cagrilintide a GLP-1 drug?

No. Cagrilintide is an amylin analogue. Its relevance is that amylin can complement GLP-1 therapy rather than duplicate it.

Not yet demonstrated

Is amylin one of the main beyond-GLP-1 mechanisms?

Partially supported. Cagrilintide has standalone human data, combination Phase 3 evidence through CagriSema, and a dedicated Phase 3 monotherapy program. That makes amylin one of the most credible next mechanisms, though not the only one.

Some supporting evidence

Is standalone cagrilintide FDA-approved?

No. There is no approved cagrilintide monotherapy product. It remains investigational.

Not yet demonstrated

Safety & side effects

The published Phase 2 trial reported gastrointestinal adverse events as the most frequent category, especially nausea, constipation, and diarrhea. Injection-site reactions also appeared. This is directionally consistent with amylin biology and with the broader incretin/amylin development landscape.[1]

Safety gaps to keep clear:

  • No approved-product label.
  • No post-marketing surveillance.
  • Limited long-term standalone exposure.
  • Uncertain comparative tolerability versus semaglutide, tirzepatide, or CagriSema.

Cagrilintide is promising because it is different from GLP-1, not because it is side-effect free. The dedicated Phase 3 monotherapy trials are the key dataset to watch for standalone tolerability.

Cagrilintide is not FDA-approved as a standalone medicine. It is part of CagriSema, which is under FDA review — Novo told investors in August 2026 that it expects a US decision in the fourth quarter of 2026, its own guidance rather than a published FDA action date. Even if CagriSema is approved, that would not make cagrilintide an approved monotherapy: the two are separate regulatory questions, and the standalone Phase 3 trials have not reported.[5][9]

A note on the programme name. Novo's 2025 annual report refers to the dedicated cagrilintide monotherapy programme as RENEW. That name does not appear in the ClinicalTrials.gov records for these trials, so this page identifies them by registry number instead — NCT07220642 in overweight and obesity, and NCT07220759 in overweight and obesity with type 2 diabetes.[6][7]

For athletes, cagrilintide should be treated as prohibited under WADA S0 because it is an unapproved pharmacological substance.[10]

Comparisons

Profile Mechanism Main evidence status
Cagrilintide Amylin analogue Phase 2 + REDEFINE monotherapy arm + dedicated Phase 3
CagriSema Cagrilintide + semaglutide Phase 3 published; NDA filed
Amycretin Single-molecule GLP-1 + amylin Strong early oral/injectable data; Phase 3 starting
Semaglutide GLP-1 receptor agonist FDA-approved benchmark

Related content

Peptide

CagriSema Profile

The cagrilintide + semaglutide fixed-dose combination now under FDA review.

Peptide

Amycretin Profile

A single-molecule GLP-1/amylin agonist that reflects the same amylin trend from another direction.

Peptide

Semaglutide Profile

The GLP-1 comparator and CagriSema partner molecule.

Peptide

Tirzepatide Profile

The approved dual incretin benchmark for comparing next-generation metabolic peptides.

References

  1. [1]
    Lau DCW, Erichsen L, Francisco AM, et al.. “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.” Lancet. 2021. 398(10317):2160-2172 DOI PubMedRCT

    Direct cagrilintide monotherapy dose-finding trial. 706 participants randomized to cagrilintide doses, liraglutide, or placebo.

  2. [2]
    Kruse T, Hansen JL, Dahl K, et al.. “Development of Cagrilintide, a Long-Acting Amylin Analogue.” J Med Chem. 2021. 64(15):11183-11194 DOI PubMedAnimal study

    Novo Nordisk medicinal chemistry paper describing the design and selection of cagrilintide as a stable, lipidated long-acting amylin analogue.

  3. [3]
    Frias JP, Deenadayalan S, Erichsen L, et al.. “Efficacy and safety of co-administered once-weekly cagrilintide 2.4 mg with once-weekly semaglutide 2.4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial.” Lancet. 2023. 402:720-730 DOI PubMedRCT

    Small but important T2D trial comparing cagrilintide, semaglutide, and their co-administration.

  4. [4]
    Garvey WT, Blüher M, Osorto Contreras CK, et al.. “Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity.” N Engl J Med. 2025. 393(7):635-647 DOI PubMedRCT

    REDEFINE 1 includes cagrilintide 2.4 mg monotherapy arm alongside CagriSema, semaglutide, and placebo.

  5. [5]
    Novo Nordisk. “Novo Nordisk Annual Report 2025 — Innovation and therapeutic focus.” 2026. LinkReview

    Summarizes REDEFINE 1 cagrilintide monotherapy results and states that cagrilintide has entered the RENEW Phase 3 program.

  6. [6]
    ClinicalTrials.gov. “NCT07220642: Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide.” 2026. LinkRegistered trial (no results)

    Registry record for the dedicated Phase 3 cagrilintide monotherapy obesity trial. 300 participants, started November 5, 2025, active and no longer recruiting. The registry title does not use the 'RENEW' programme name that appears in Novo's annual report. A trial registration, not a result.

  7. [7]
    ClinicalTrials.gov. “NCT07220759: Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide.” 2026. LinkRegistered trial (no results)

    Registry record for the companion Phase 3 cagrilintide monotherapy trial in people who also have type 2 diabetes. 330 participants, started November 5, 2025, active and no longer recruiting. A trial registration, not a result.

  8. [8]
    Novo Nordisk. “Q1 2026 Investor Presentation.” 2026. LinkReview

    Corporate update describing the dedicated Phase 3 monotherapy programme and summarized cagrilintide tolerability metrics.

  9. [9]
    Novo Nordisk. “Investor presentation, Second quarter of 2026.” 2026. LinkReview

    Corporate investor presentation dated August 5, 2026. Lists a high-dose cagrilintide Phase 3 initiation under upcoming clinical milestones for Q4 2026 and places cagrilintide (NN9833) in the Phase 3 column. Also the source for Novo's expectation of a US decision on CagriSema in Q4 2026 — company guidance, not an FDA-disclosed action date.

  10. [10]
    World Anti-Doping Agency. “The 2026 Prohibited List.” 2026. LinkReview

    Used for S0 non-approved-substance regulatory context.

Medical disclaimer

Peptide Garden is an educational resource, not a medical provider. This page is informational and does not constitute medical advice. Cagrilintide is investigational and should not be used outside regulated clinical trials or approved medical pathways.