Investigational long-acting amylin analogue; CagriSema combines it with semaglutide

Cagrilintide

aka AM833 · NN0174-0833

Evidence grade
Grade B: Moderate human evidence
for weight management (alone and as CagriSema with semaglutide)
User score No user reports found needs ≥ 10 reports
US FDA Not approved checked 2026-11-13
WADA 2026 Likely prohibited (S0) by class rule · checked 2026-11-13
EU EMA marketing authorization not found; a cagrilintide/semaglutide paediatric-investigation-plan decision exists and is not marketing approval. · checked 2026-11-13

Goals: Fat loss Compare with another peptide →

In stacks: CagriSema

How it’s taken

Primary route: Subcutaneous injection
Primary routeSubcutaneous injection
  • Refillable multi-dose pen (unapproved use)
  • Trial
  • User-reported
Every route on record (3) with its dose range and source
Routes, devices, status, dose ranges and sources for Cagrilintide
RouteDeviceStatusDose rangeSource
Subcutaneous injection Refillable multi-dose pen (unapproved use) Trial 0.3, 0.6, 1.2, 2.4 or 4.5 mg once weekly for 26 weeks (clinical trial) · route: Subcutaneous injection Source
Subcutaneous injection — User-reported no dose range recorded Reddit thread
Subcutaneous injection Refillable multi-dose pen (unapproved use) User-reported no dose range recorded Reddit thread

“User-reported” means people describe taking it this way online. It is not a recommendation and not evidence that the route works. Handling and safety guide.

User reports

No user reports found. Both Reddit reads came back without countable reports for Cagrilintide.

Summary

Cagrilintide is an investigational long-acting amylin analogue studied for weight management. CagriSema combines cagrilintide with the GLP-1 receptor agonist semaglutide. Cagrilintide alone has human randomized evidence; the larger combination effects belong to CagriSema. Phase 2 trial; REDEFINE 1

Evidence grade: B for weight management. FDA approval was not found as of 2026-11-13. FDA

How it works proposed mechanisms, in plain words

  • Fullness signaling

    Fullness signaling

    It mimics amylin, a hormone that helps the brain recognize fullness.

  • Longer hormone action

    Longer hormone action

    Its modified structure allows the fullness signal to last longer than natural amylin.

Mechanism in more detail

Cagrilintide (AM833; NN0174-0833) is a lipidated amylin analogue with amylin- and calcitonin-receptor activity in pharmacology experiments. Development paper; Receptor study. Amylin signalling promotes satiety and reduces food intake. Cagrilintide extends that hormone pathway's action; semaglutide adds GLP-1 receptor activity. This complementary pharmacology explains why the combination is studied, while trial comparisons establish its clinical effects. Lau et al.; REIMAGINE 2

Keeping muscle on GLP-1 drugs — protein and resistance training during weight loss.

Safety

  • Gastrointestinal symptoms and injection-site reactions in cagrilintide trials.
  • CagriSema caused more gastrointestinal adverse events and adverse-event discontinuations than placebo.
  • Serious events, gallbladder disorders and pancreatitis occurred in CagriSema trials; causality and component attribution require caution.
  • No approved cagrilintide/CagriSema contraindication list found; trial eligibility is not an approved label.
  • Long-term cardiovascular outcome benefit and safety of other improvised combinations are not established.

From labels, regulators and trials. No signal in small studies ≠ safe.

Evidence B weight management (alone and as CagriSema with semaglutide)

Positive randomized human weight-management trials support cagrilintide alone and CagriSema, but regulatory approval was not found, so the rubric does not permit A.

Trial result

Phase 2 dose-finding trial, 26 weeks, 706 adults without diabetes% body weight lost
Phase 2 dose-finding trial, 26 weeks, 706 adults without diabetes — % body weight lost
Arm% body weight lost
Placebo3
0.3 mg weekly6
0.6 mg weekly6.8
1.2 mg weekly9.1
2.4 mg weekly9.7
4.5 mg weekly10.8
Liraglutide 3 mg daily9

Source: Lau et al. Lancet. 2021;398:2160–2172; Table 2; doi:10.1016/S0140-6736(21)01751-7. Open

Primary weight outcome, trial-product estimand; losses shown as positive magnitudes. All seven arms included; 706 is the total randomized population. This is cagrilintide monotherapy, not CagriSema. Charts from separate studies are not head-to-head comparisons.

Human trials · 8

  1. PMID 34798060 / NCT038560472021RCT; placebo-controlled and active-controlled phase 2 706 people

    Adults with overweight/obesity without diabetes; 706 total randomized across all seven groups

    At 26 weeks, clinical-trial cagrilintide targets 0.3/0.6/1.2/2.4/4.5 mg weekly gave 6.0/6.8/9.1/9.7/10.8% weight loss; placebo 3.0%; trial-product estimand. Source

  2. PMID 37364590 / NCT049825752023RCT; double-blind phase 2 92 people

    Adults with type 2 diabetes and BMI at least 27

    At 32 weeks, clinical-trial CagriSema 2.4/2.4 mg weekly: 15.6% weight loss; semaglutide 2.4 mg: 5.1%; cagrilintide 2.4 mg: 8.1%; trial-product estimates. Source

  3. PMID 40544433 / NCT055677962025RCT; double-blind phase 3a, REDEFINE 1 3,417 people

    Overweight/obesity without diabetes; 302 assigned cagrilintide alone

    At 68 weeks, clinical-trial CagriSema 2.4/2.4 mg: 20.4%; semaglutide 2.4 mg: 14.9%; cagrilintide 2.4 mg: 11.5%; placebo: 3.0% weight loss, treatment-policy estimand. Source

  4. PMID 40544432 / NCT053945192025RCT; double-blind phase 3a, REDEFINE 2 1,206 people

    Overweight/obesity with type 2 diabetes

    At 68 weeks, clinical-trial CagriSema 2.4/2.4 mg weekly: 13.7% versus placebo 3.4% weight loss, treatment-policy estimand. Source

  5. NCT061314372026RCT; open-label phase 3, REDEFINE 4; sponsor topline 809 people

    Obesity with at least one comorbidity

    At 84 weeks, clinical-trial CagriSema 2.4/2.4 mg versus tirzepatide 15 mg weekly: 23.0% versus 25.5% efficacy; 20.2% versus 23.6% treatment-regimen weight loss; non-inferiority endpoint failed.

  6. PMID 42009015 / NCT058139252026RCT; double-blind phase 3a, REDEFINE 5 331 people

    Adults in Japan/Taiwan with overweight/obesity, with or without type 2 diabetes

    At 68 weeks, clinical-trial CagriSema 2.4/2.4 mg versus semaglutide 2.4 mg weekly: 18.4% versus 11.9% weight loss, trial-product estimand. Source

  7. NCT063881872026RCT; phase 3, REDEFINE 9; sponsor-reported results 300 people

    Adults with overweight/obesity

    At 68 weeks, clinical-trial CagriSema 1.0/1.0 mg: 20.95%; 1.7/1.7 mg: 20.75%; placebo about 2.0% weight loss, efficacy estimand (Q3 slide 55); treatment-policy estimates not found.

  8. PMID 42251859 / NCT060655402026RCT; double-blind phase 3, REIMAGINE 2 2,713 people

    Type 2 diabetes on metformin with or without SGLT2 inhibitor; BMI at least 25

    At 68 weeks, clinical-trial CagriSema 2.4/2.4 mg versus semaglutide 2.4 mg weekly reduced HbA1c 1.91 versus 1.75 percentage points, efficacy estimand. Source

Bar length = trial size on a log scale.

Doses

Ranges from labels and studies, each with its route and source, then what Reddit users said they took. Not a recommendation.

Dose ladder · clinical trial Trial Route: Subcutaneous injection
Start
0.3 mg
Typical
0.3–4.5 mg
Max
4.5 mg
How often
once weekly

Source: clinical trial · open source. Phase 2 SC targets 0.3, 0.6, 1.2, 2.4 or 4.5 mg: the 0.3 mg arm started at 0.3 mg, all others at 0.6 mg with two-week escalation intervals; highest tested target is not an established safe maximum.

Dose ladder for Cagrilintide: start 0.3 · typical 0.3–4.5 mg · max 4.5 mg, once weekly. Route: Subcutaneous injection. Source: clinical trial.

What Reddit users said they took — user-reported, not advice: no range shown. No Reddit reports for this substance.

All dose ranges on record · 3

  • clinical trialTrialRoute: Subcutaneous injection
    Cagrilintide alone: target range 0.3–4.5 mg subcutaneously once weekly in 26-week phase 2; 2.4 mg weekly in REDEFINE 1. Source
  • clinical trialTrialRoute: Subcutaneous injection
    CagriSema target pairs, cagrilintide/semaglutide: 1.0/1.0–2.4/2.4 mg subcutaneously once weekly in completed REDEFINE trials; includes 1.7/1.7 mg. Source on a non-primary host — not linked
  • clinical trialTrialRoute: Subcutaneous injection
    High-dose CagriSema target pair 2.4/7.2 mg weekly under study; no efficacy result found. Source on a non-primary host — not linked

Editorial ratings EDITORIAL

Editors’ judgement, 0–5. Opinion, not data; separate from grade and user score.

Not rated yet.

Sources

  1. pubmed.ncbi.nlm.nih.gov/34798060/
  2. pubmed.ncbi.nlm.nih.gov/37364590/
  3. pubmed.ncbi.nlm.nih.gov/40544433/
  4. pubmed.ncbi.nlm.nih.gov/40544432/
  5. pubmed.ncbi.nlm.nih.gov/42009015/
  6. pubmed.ncbi.nlm.nih.gov/42251859/
  7. fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-
  8. wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
  9. ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000240529

3 further sources on commercial or non-primary hosts not listed.

Research checked 2026-11-13.