Peptide Checkup

Compound record · Metabolic (incretin-based)

Cagrilintide

Also NNC0174-0833 · AM833 · Cagri · CagriSema (with semaglutide)

Long-acting amylin analogue

Metabolic (incretin-based)Evidence · ModerateLate-stage clinical trials

Investigational weekly amylin analogue, studied alone and with semaglutide (CagriSema)

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Record reviewed 1 September 2026 · 5 references

In the AERVYN range

1 pen carries Cagrilintide

Status
Investigational — CagriSema under FDA review; not authorised anywhere
Class
Long-acting amylin analogue
Route
Weekly subcutaneous injection (trials only)
Trial weight loss
≈ 11% alone (26 weeks); ≈ 20% with semaglutide (68 weeks)
Prescription
Not available by prescription; clinical trials only

01 Overview

What Cagrilintide is

Summary

Cagrilintide is an investigational once-weekly, long-acting analogue of amylin, the satiety hormone co-secreted with insulin. Alone it produced up to 10.8% weight loss at 26 weeks in phase 2; combined with semaglutide 2.4 mg as CagriSema it produced 20.4% weight loss at 68 weeks in the phase 3 REDEFINE 1 trial. CagriSema was submitted to the FDA in December 2025, but neither cagrilintide nor the combination is authorised anywhere.

Mechanism

Activates amylin and calcitonin receptors: slows gastric emptying, suppresses post-meal glucagon and acts on hindbrain (area postrema) and hypothalamic satiety circuits to reduce food intake. A lipidated structure extends the half-life to about a week. The pathway is distinct from, and additive to, GLP-1 receptor activation.

Routes studiedSubcutaneous injection
Anti-dopingNot prohibited

02 Evidence by goal

What has been shown, for which goal

Grades follow one scale across the site. Moderate overall means: at least one well-conducted randomised trial or consistent controlled human studies.

  1. Weight management

    Moderate

    Alone: 6.0–10.8% weight loss at 26 weeks across 0.3–4.5 mg weekly versus 3.0% with placebo (phase 2, n = 706), and approximately 12% at 68 weeks in the 2.4 mg monotherapy arm of REDEFINE 1. Combined with semaglutide 2.4 mg (CagriSema): 20.4% versus 3.0% with placebo at 68 weeks (n = 3,417).

  2. Fat loss / body composition

    Preliminary

    Trials report large reductions in waist circumference alongside weight loss; detailed fat-versus-lean-mass data for cagrilintide alone are limited to small sub-studies and have not been fully published.

  3. Longevity

    Insufficient

    No cardiovascular-outcome data exist for cagrilintide or CagriSema; a dedicated outcomes trial (REDEFINE 3) is ongoing.

03 Regulatory status

Where it is authorised, and for what

Status is recorded per jurisdiction from regulator sources and reviewed by hand. It is never inferred from another region's decision.

United Kingdom

Investigational

Not authorised; in phase 3 trials (REDEFINE programme).

No MHRA marketing authorisation for cagrilintide or CagriSema, and no UK filing publicly confirmed as of last review. Products sold online as 'cagrilintide' are unregulated and cannot lawfully be supplied as a medicine.

StatusInvestigational
Status last reviewed1 September 2026
SourceOur maintained database — never inferred

04 Dosing research

What the evidence says about exposure

Published human studies and the doses, routes and durations they used — reported as research information, not a recommendation.

Research information — not a recommendation. These are the exposures used in published human studies, reported so you can see what has been tested. They are not dosing instructions and do not apply to any individual.

Study 01

Phase 2 — once-weekly cagrilintide monotherapy in adults with overweight or obesity

Lau DCW et al., Lancet 2021;398:2160–2172 · Source

Phase 22021
Design
Randomised, double-blind, placebo- and active-controlled (liraglutide 3.0 mg), dose-finding
Population
Adults without diabetes with BMI ≥ 30, or ≥ 27 with hypertension or dyslipidaemia
Participants
n = 706
Duration
26 weeks
Route
Subcutaneous injection
Doses studied
0.3, 0.6, 1.2, 2.4 or 4.5 mg once weekly after dose escalation; liraglutide 3.0 mg daily as active comparator
Outcome at this exposure
Mean weight loss 6.0% (0.3 mg) to 10.8% (4.5 mg) vs 3.0% with placebo and 9.0% with liraglutide 3.0 mg; all cagrilintide doses were superior to placebo.
Adverse events observed
Gastrointestinal events (mainly nausea, constipation and diarrhoea) and injection-site reactions were the most frequent adverse events, mostly mild-to-moderate and transient; overall adverse-event rates were similar to liraglutide.

Study 02

REDEFINE 1 — CagriSema, cagrilintide alone and semaglutide alone in adults with overweight or obesity

Garvey WT et al., N Engl J Med 2025;393:635–647 · Source

Phase 32025
Design
Randomised, double-blind, placebo- and active-controlled
Population
Adults without diabetes with BMI ≥ 30, or ≥ 27 with ≥ 1 obesity-related complication
Participants
n = 3,417
Duration
68 weeks
Route
Subcutaneous injection
Doses studied
Cagrilintide 2.4 mg + semaglutide 2.4 mg once weekly (CagriSema), cagrilintide 2.4 mg alone, semaglutide 2.4 mg alone, or placebo, after a 16-week escalation
Outcome at this exposure
Mean weight change −20.4% with CagriSema vs −3.0% with placebo (treatment-policy estimand; −22.7% vs −2.3% if all participants had stayed on treatment); approximately −15% with semaglutide alone and −12% with cagrilintide alone; 91.9% on CagriSema lost ≥ 5% vs 31.5%.
Adverse events observed
Gastrointestinal events in 79.6% with CagriSema vs 39.9% with placebo (nausea, vomiting, diarrhoea, constipation, abdominal pain), mainly transient and mild-to-moderate.

REDEFINE 2 (adults with type 2 diabetes) reported approximately 14% weight loss with CagriSema versus about 3% with placebo at 68 weeks, and the open-label REDEFINE 4 trial (2026) did not show non-inferiority of CagriSema to tirzepatide 15 mg at 84 weeks. All data relate to the 2.4 mg weekly dose reached by gradual escalation.

05 Safety

Adverse effects and contraindications

Common effects seen in trials or reports, serious effects that warrant urgent review, and conditions under which use is not appropriate or needs assessment.

Common adverse effects

  • Nausea
  • Constipation
  • Diarrhoea
  • Vomiting
  • Reduced appetite and early satiety
  • Dyspepsia and abdominal pain
  • Injection-site reactions
  • Fatigue
  • Headache

Serious adverse effects

  • Severe hypoglycaemia when combined with insulin (amylin class warning)
  • Gallbladder disease with rapid weight loss
  • Acute pancreatitis (reported in incretin-combination trials; causality unclear)
  • Dehydration and acute kidney injury from persistent vomiting or diarrhoea
  • Unknown long-term safety — no data beyond about 84 weeks
  • Severe allergic reactions (theoretical; peptide immunogenicity)

Contraindications

  • Gastroparesis (slow stomach emptying)Do not use

    Amylin analogues slow gastric emptying; the authorised short-acting amylin analogue pramlintide is contraindicated in gastroparesis and trials excluded it.

  • Gastrointestinal diseaseCaution

    Not studied in severe gastrointestinal disease; slowed gastric emptying may worsen symptoms.

  • DiabetesCaution

    Pramlintide carries a boxed warning for severe insulin-induced hypoglycaemia; cagrilintide has only been studied in type 2 diabetes within REDEFINE 2 alongside semaglutide, and not in type 1 diabetes.

  • Previous pancreatitisCaution

    Trials excluded previous pancreatitis; the CagriSema combination carries semaglutide's pancreatitis warning.

  • Gallbladder diseaseCaution

    Gallstone disease is more common with rapid, large weight loss such as that seen with CagriSema.

  • Kidney diseaseCaution

    Dehydration from vomiting or diarrhoea can cause acute kidney injury; no data in significant kidney disease.

  • Personal or family history of medullary thyroid cancer or MEN2Caution

    Not a known concern for amylin analogues themselves, but the CagriSema combination includes semaglutide, which carries the thyroid C-cell warning.

  • Mental health conditionCaution

    Authorised weight-management medicines carry monitoring advice for depression and suicidal thoughts; no cagrilintide-specific data.

  • Current or previous eating disorderCaution

    Appetite-suppressing compounds require specialist assessment where there is a current or previous eating disorder.

Do not use = should not be used · Caution = needs assessment

06 Interactions

Medicine classes that need review

Grouped by how seriously the combination should be taken. Class labels match the medicines questionnaire in the assessment.

  • Major
  • Moderate
  • Minor

Major

Combination should be reviewed by a prescriber before use.

  • Insulin

    Lantus, NovoRapid, Humalog, Tresiba

    Amylin analogues combined with insulin can cause severe hypoglycaemia (boxed warning for pramlintide); no cagrilintide data in insulin users.

Moderate

Monitoring or dose review is usually advised.

  • Sulfonylurea

    Gliclazide, glimepiride, glipizide

    Hypoglycaemia risk would rise, particularly in the CagriSema combination; no dedicated interaction data.

  • GLP-1 / incretin medicine

    Ozempic, Wegovy, Mounjaro, Saxenda

    Only studied as the fixed CagriSema combination with semaglutide 2.4 mg in trials; combining with any other incretin medicine is untested.

  • Anticoagulant (blood thinner)

    Warfarin, apixaban, rivaroxaban

    Delayed gastric emptying can alter absorption of oral medicines; closer INR monitoring would be prudent with warfarin.

  • Narrow-therapeutic-index medicine

    Lithium, digoxin, ciclosporin

    Medicines that depend on rapid absorption or have a narrow therapeutic window may need closer monitoring.

Minor

Generally compatible; awareness is sufficient.

  • Thyroid hormone

    Levothyroxine, liothyronine

    Levothyroxine absorption may change with slowed gastric emptying.

  • Oral contraceptive

    Combined pill, progestogen-only pill

    No interaction data; vomiting can reduce pill effectiveness.

  • Other glucose-lowering medicine

    Metformin, SGLT2 inhibitors, DPP-4 inhibitors

    Studied alongside metformin in REDEFINE 2; glucose monitoring advised.

07 Pregnancy & breastfeeding

Status in pregnancy

Insufficient data

No human data; trials exclude pregnant and breastfeeding women and require effective contraception. The semaglutide component of CagriSema is not recommended in pregnancy and has a two-month wash-out advice.

08 Monitoring

What is usually monitored

Parameters that trials and product information track. A clinician decides what applies to an individual.

  1. 01Gastrointestinal tolerability and hydration during escalation
  2. 02Blood glucose if on insulin or other glucose-lowering medicines
  3. 03Kidney function during vomiting or diarrhoea
  4. 04Weight, muscle mass and protein intake during rapid weight loss
  5. 05Mood and mental health
  6. 06Injection-site reactions

09 Combinations

What is known about combining it

Notes on pairing with other compounds in the directory: whether the combination has been studied in people, and where mechanisms overlap.

  • Semaglutide

    Studied together in humans

    Overlap · Complementary appetite pathways (amylin + GLP-1); both slow gastric emptying.

    The fixed combination CagriSema (2.4 mg + 2.4 mg) has phase 3 data (REDEFINE 1 and 2) and is under FDA review, but it remains investigational and is not authorised anywhere.

  • Tirzepatide

    No human studies

    Overlap · Both reduce appetite and slow gastric emptying.

    No human data on cagrilintide with tirzepatide; only the semaglutide combination has been studied.

  • Liraglutide

    No human studies

    Overlap · Both reduce appetite and slow gastric emptying.

    Liraglutide 3.0 mg was the active comparator, not a partner, in the phase 2 trial; no combination data.

  • Retatrutide

    No human studies

    Overlap · Both suppress appetite and slow gastric emptying.

    Never studied together; both are investigational.

  • Survodutide

    No human studies

    Overlap · Both suppress appetite and slow gastric emptying.

    Never studied together; both are investigational.

  • CJC-1295

    No human studies

    No human studies of amylin analogues combined with growth-hormone secretagogues.

  • Ipamorelin

    No human studies

    No human studies of amylin analogues combined with growth-hormone secretagogues.

  • BPC-157

    No human studies

    No human data on this combination; BPC-157 itself lacks human efficacy data.

Discuss any proposed combination with a qualified healthcare professional.

10 Source considerations

Supply, quality and legitimacy

How the compound reaches people in practice, and what that means for product quality.

  1. 01No authorised product exists anywhere — vials sold as 'cagrilintide' or 'CagriSema' online are unregulated, with no assurance of identity, purity, sterility or dose.
  2. 02The only lawful route of access is enrolment in a registered clinical trial; if the FDA approves CagriSema it will be a prescription-only fixed combination, not a stand-alone cagrilintide product.
  3. 03Regulators including the FDA and MHRA have warned about unapproved weight-loss injections sold online and through social media.
  4. 04Athletes: cagrilintide is not named on the WADA Prohibited List, but WADA's S0 category covers substances without regulatory approval for human use; competitors should seek anti-doping advice.

11 Questions for your clinician

Take these to your appointment

Specific to this compound. The personal assessment adds questions drawn from your own history and medicines.

  1. 01Is there a clinical trial of cagrilintide or CagriSema I could be eligible for?
  2. 02Given that semaglutide and tirzepatide are authorised, what would an amylin analogue add for my goal?
  3. 03How would hypoglycaemia risk be managed if I take insulin or a sulfonylurea?
  4. 04How would nausea and gastric-emptying effects be monitored with a compound that has no label?
  5. 05What is known about weight regain after stopping?

The personal assessment tailors this list to your responses.

12 Alternatives

Compounds with stronger evidence or firmer regulatory footing

Listed for overlapping goals. Whether any is appropriate depends on your history — the assessment maps that for you.

13 References

Sources behind this record

Regulator documents and peer-reviewed publications used to derive every grade and statement above.

  1. 01Lau DCW et al. Cagrilintide phase 2. Lancet 2021
  2. 02Garvey WT et al. REDEFINE 1 — CagriSema. NEJM 2025
  3. 03Enebo LB et al. Cagrilintide + semaglutide phase 1b. Lancet 2021
  4. 04Novo Nordisk — CagriSema NDA submission (press release, December 2025)
  5. 05ClinicalTrials.gov — cagrilintide studies

The Peptide Checkup provides educational information and a structured summary of published research and regulatory status. It is not medical advice, does not diagnose or treat any condition, and does not replace a consultation with a qualified healthcare professional.

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