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Metabolic

Cagrilintide

Also known as CagriSema (combination with semaglutide)

InvestigationalAHuman trial evidenceWhat this means

Cagrilintide is an investigational long-acting, lipidated analogue of the pancreatic hormone amylin that acts at amylin and calcitonin receptors and is given by once-weekly subcutaneous injection in clinical trials. It has been studied alone in a phase 2 weight-management trial and, most extensively, in combination with semaglutide (CagriSema) in phase 3 trials, with gastrointestinal events the most commonly reported adverse events. It is not approved by the FDA, and this entry summarizes published and registered trials for research reference only.

US status
Investigational
Evidence
Grade A
Half-life
159 to 195 hours (phase 1b, co-administered with semaglutide 2.4 mg) 2
Class
Long-acting amylin analogue; dual amylin and calcitonin receptor agonist (investigational)
Studied in: Appetite & body weight · Metabolic & insulin research · Class: Amylin analogues
More
Log a sampleCagriSema (cagrilintide + semaglutide)Cagrilintide + TirzepatideCagrilintide + Retatrutide
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Unbranded reference vial illustrating Cagrilintide; not an actual product
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Key takeaways

  • Cagrilintide is an investigational once-weekly amylin analogue that binds amylin receptors (AMY1R, AMY2R, AMY3R) and the calcitonin receptor; it is not FDA-approved 8,13.
  • In a 26-week phase 2 trial of cagrilintide alone (706 adults with overweight or obesity), mean weight reduction was 6.0% to 10.8% across five dose levels versus 3.0% with placebo 1.
  • In a 32-week phase 2 trial in type 2 diabetes, the cagrilintide-only arm reached an HbA1c change of -0.9 percentage points and a body-weight change of -8.1% 3.
  • In REDEFINE 1 (3,417 adults without diabetes), the cagrilintide-semaglutide combination produced a mean weight change of -20.4% at 68 weeks versus -3.0% with placebo; the trial also randomized 302 participants to cagrilintide alone 4.
  • Gastrointestinal events were the most frequent adverse events; in the phase 2 monotherapy trial they affected 41% to 63% of cagrilintide groups versus 32% with placebo 1.

Development stage

Where Cagrilintide sits between laboratory work and regulatory approval.

  1. Preclinical
  2. Phase 1
  3. Phase 2
  4. Phase 3 (current)
  5. Approved

Stage comes from the regulatory record and ClinicalTrials.gov studies naming the compound (for compounds approved nowhere, only completed trials or trials with posted results count) (checked 2026-10-24). A registered trial is not a result.

Mechanism of action

Natural amylin is a pancreatic hormone co-secreted with insulin that induces satiety; cagrilintide is a stable, lipidated, long-acting amylin analogue 1,7.

Receptor pharmacology

Cryo-electron microscopy structures show cagrilintide bound to Gs-coupled amylin receptors (AMY1R, AMY2R, AMY3R) and the calcitonin receptor, with an amylin-like binding mode but distinct conformational dynamics compared with other peptides 8.

Animal pharmacology

In diet-induced obese mice, cagrilintide reduced body weight and early food intake, and its potency was impaired in mice lacking RAMP1 and RAMP3, indicating dependence on AMY1R and AMY3R; neuronal activation was observed in the dorsal vagal complex and lateral parabrachial nucleus 9.

Human pharmacokinetics

In a phase 1b trial, cagrilintide exposure was proportional to dose, did not affect semaglutide exposure, and had a half-life of 159 to 195 hours 2.

Molecular structure

PubChem CID 171397054 ↗
2D chemical structure of Cagrilintide

2D depiction generated from the PubChem record. Depictions are schematic and do not show salt form, counter-ions or conformation.

Formula
C194H312N54O59S2
Molecular weight
4409 g/mol
CAS
1415456-99-3
InChIKey
LDERDVMBIYGIOI-IZVMHKDJSA-N

Research overview

Human research

A 26-week phase 2 trial of once-weekly cagrilintide alone in 706 adults with overweight or obesity reported mean weight reductions of 6.0% to 10.8% across dose levels versus 3.0% with placebo and 9.0% with liraglutide 3.0 mg 1. Phase 3 trials of the cagrilintide-semaglutide combination reported a mean weight change of -20.4% at 68 weeks in adults without diabetes (REDEFINE 1) and -13.7% in adults with type 2 diabetes (REDEFINE 2), versus -3.0% and -3.4% with placebo 4,5. REIMAGINE 2, in type 2 diabetes, included a cagrilintide-only arm (152 participants) alongside the combination and semaglutide arms 6. A secondary analysis of REDEFINE 1 reported systolic blood-pressure change of -10.9 versus -2.8 mm Hg with the combination versus placebo at 68 weeks 10.

Animal research

In high-fat-diet-fed mice, cagrilintide decreased body weight and early food intake in wild-type animals, and these effects were reduced in RAMP1/3 knockout mice 9.

In-vitro research

Structural studies show cagrilintide engaging AMY1R, AMY2R, AMY3R and the calcitonin receptor with an amylin-like binding mode 8; medicinal chemistry work describes structure-activity optimization against amylin's amyloid-forming tendency 7.

Key studies

  1. Lau et al., Lancet (phase 2, monotherapy) (2021)
    Randomized, double-blind, placebo- and active-controlled dose-finding phase 2, 26 weeks, 706 participants (NCT03856047)
    Model: Humans (adults with overweight or obesity without diabetes)

    Mean weight reduction was 6.0% to 10.8% across cagrilintide doses versus 3.0% with placebo; the highest dose exceeded liraglutide 3.0 mg (10.8% vs 9.0%); gastrointestinal adverse events occurred in 41% to 63% versus 32% with placebo 1.

  2. Enebo et al., Lancet (phase 1b, with semaglutide) (2021)
    Randomized, placebo-controlled, multiple-ascending-dose phase 1b, 20 weeks of treatment, 96 participants (NCT03600480)
    Model: Humans (otherwise healthy adults with BMI 27.0 to 39.9)

    Most adverse events were mild to moderate and 37% were gastrointestinal; cagrilintide half-life was 159 to 195 hours, and weight reduction at week 20 was greater with cagrilintide 1.2 mg and 2.4 mg plus semaglutide than with placebo plus semaglutide 2.

  3. Frias et al., Lancet (phase 2, type 2 diabetes) (2023)
    Randomized, double-blind, active-controlled phase 2, 32 weeks, 92 participants (NCT04982575)
    Model: Humans (adults with type 2 diabetes and BMI 27 or higher on metformin)

    HbA1c change was -2.2 (combination), -1.8 (semaglutide) and -0.9 (cagrilintide alone) percentage points; body-weight change was -15.6%, -5.1% and -8.1%; adverse events were reported by 68%, 71% and 80%, with no level 2 or 3 hypoglycaemia 3.

  4. Garvey et al., N Engl J Med (REDEFINE 1) (2025)
    Randomized, double-blind, placebo- and active-controlled phase 3a, 68 weeks, 3,417 participants randomized 21:3:3:7 to combination, semaglutide, cagrilintide or placebo (NCT05567796)
    Model: Humans (adults without diabetes with obesity, or overweight with a complication)

    Mean weight change was -20.4% with cagrilintide-semaglutide versus -3.0% with placebo; gastrointestinal adverse events affected 79.6% versus 39.9% 4. The abstract does not report the cagrilintide-only arm result.

  5. Davies et al., N Engl J Med (REDEFINE 2) (2025)
    Randomized, double-blind, placebo-controlled phase 3a, 68 weeks, 1,206 participants (NCT05394519)
    Model: Humans (adults with BMI 27 or higher, HbA1c 7% to 10% and type 2 diabetes)

    Mean weight change was -13.7% with cagrilintide-semaglutide versus -3.4% with placebo; gastrointestinal adverse events were reported by 72.5% versus 34.4% 5.

  6. Buse et al., Lancet Diabetes Endocrinol (REIMAGINE 2) (2026)
    Randomized, double-blind, placebo- and active-controlled phase 3, 68 weeks, 2,713 participants including 152 on cagrilintide alone (NCT06065540)
    Model: Humans (adults with type 2 diabetes on metformin with or without an SGLT2 inhibitor, BMI 25 or higher)

    HbA1c change was -1.91 with the 2.4 mg combination versus -1.75 percentage points with semaglutide 2.4 mg; adverse events were reported by 82.2% of the cagrilintide-only group versus 70.5% with placebo 6.

Doses used in published trials

What investigators administered in the cited studies, recorded as a fact about those studies. Not a protocol and not a recommendation.

Full dosing reference, study durations and vial arithmetic →
  • In the phase 2 dose-finding trial (NCT03856047), adults with overweight or obesity self-injected subcutaneous cagrilintide 0.3, 0.6, 1.2, 2.4 or 4.5 mg once weekly, once-daily liraglutide 3.0 mg, or volume-matched placebo for 26 weeks, including a dose-escalation period of up to 6 weeks, followed by 6 weeks without treatment 1.
  • In the phase 1b trial (NCT03600480), participants received once-weekly subcutaneous cagrilintide 0.16, 0.30, 0.60, 1.2, 2.4 or 4.5 mg or placebo together with once-weekly semaglutide 2.4 mg; doses were co-escalated at 4-week intervals over 16 weeks, then held at target for 4 weeks 2.
  • In the phase 2 type 2 diabetes trial (NCT04982575), participants were randomized 1:1:1 to once-weekly subcutaneous cagrilintide-semaglutide, semaglutide or cagrilintide, all escalated to 2.4 mg, for 32 weeks 3.
  • In REDEFINE 1 (NCT05567796), participants received once-weekly cagrilintide 2.4 mg plus semaglutide 2.4 mg, semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone, or placebo for 68 weeks; the registry describes a 16-week dose-escalation period followed by maintenance 4,12.
  • In REDEFINE 2 (NCT05394519), adults with type 2 diabetes received once-weekly cagrilintide-semaglutide (2.4 mg each) or placebo for 68 weeks 5.
  • In REIMAGINE 2 (NCT06065540), participants received once-weekly subcutaneous cagrilintide 2.4 mg plus semaglutide 2.4 mg, semaglutide 2.4 mg, cagrilintide 2.4 mg, cagrilintide 1.0 mg plus semaglutide 1.0 mg, semaglutide 1.0 mg, or placebo for 68 weeks 6.

Cagrilintide draw calculator

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Published adverse-event data

Reported in the cited trials or product labels. Frequencies apply to the stated population and do not transfer to other settings.

  • Gastrointestinal adverse events (cagrilintide alone)
    41% to 63% across cagrilintide doses vs 32% placebo
    Phase 2 monotherapy trial, 26 weeks 1 · Mainly nausea, constipation and diarrhoea
  • Nausea (cagrilintide alone)
    20% to 47% across cagrilintide doses vs 18% placebo
    Phase 2 monotherapy trial, 26 weeks 1 · Not graded in the abstract
  • Permanent treatment discontinuation
    73 participants (10%), similar across groups; most commonly due to adverse events (30, 4%)
    Phase 2 monotherapy trial 1 · Not graded
  • Any adverse event (cagrilintide alone)
    125 of 152 (82.2%) vs 105 of 149 (70.5%) placebo
    REIMAGINE 2, type 2 diabetes, 68 weeks 6 · Gastrointestinal disorders most common in active groups
  • Any adverse event (cagrilintide alone)
    24 of 30 (80%)
    Phase 2 type 2 diabetes trial, 32 weeks 3 · Mild or moderate gastrointestinal events most common; no fatal events
  • Gastrointestinal adverse events (combination)
    79.6% vs 39.9% placebo
    REDEFINE 1, adults without diabetes, 68 weeks 4 · Mainly transient and mild to moderate
  • Gastrointestinal adverse events (combination)
    72.5% vs 34.4% placebo
    REDEFINE 2, adults with type 2 diabetes, 68 weeks 5 · Mostly transient and mild or moderate

Emerging safety signals

  • A 2026 meta-analysis of three randomized trials reported a higher risk of serious adverse events with cagrilintide monotherapy than with semaglutide (risk ratio 1.83, 95% CI 1.03 to 3.24); this is a pooled estimate from few trials (meta-analysis evidence) 11. 11 (2026)
  • The same meta-analysis reported more administration-site conditions and nausea with the cagrilintide-semaglutide combination than with semaglutide, and modestly higher LDL-C (meta-analysis evidence) 11. 11 (2026)
  • In the phase 2 type 2 diabetes trial, no level 2 or 3 hypoglycaemia and no fatal adverse events were reported over 32 weeks (randomized phase 2 evidence) 3. 3 (2023)

What is not known: Cagrilintide has no regulatory label 13. The REDEFINE 1 abstract does not report weight or safety results for its cagrilintide-only arm, and the registry record had no posted results when reviewed 4,12. Long-term outcomes beyond 68 weeks, cardiovascular outcomes and effects in populations outside the trial criteria were not established in the sources reviewed 4,5. Most phase 3 data concern the combination with semaglutide, so the separate contribution of cagrilintide is mainly inferred from smaller monotherapy arms 3,6.

Clinicians and researchers on video

YouTube videos about Cagrilintide from clinicians and researchers. Their views, in their own words; not reviewed or endorsed by Amiravo. Compare what they say with the evidence above.

  • S5 Ep. 3 | The Dr. Kris Podcast | Cagrilintide For Weight Loss: Is It Right For You?
    The Resurge Clinic · 12K views

These creators are not affiliated with Amiravo and do not endorse Amiravo or any product linked on this site. Nothing here is medical advice. Video views counted on YouTube as of Oct 24, 2026.

Regulatory status

Status
Not approved by the FDA; an openFDA Drugs@FDA query for cagrilintide returned no application record 13. Cagrilintide is described in trial reports as a long-acting amylin analogue under investigation for weight management 1, and the REDEFINE 1 phase 3 trial (NCT05567796) is listed on ClinicalTrials.gov as active, not recruiting, with an extension phase 12.
United States (FDA)
Not approved; an openFDA Drugs@FDA query for cagrilintide returned no application record 13. Phase 3 trials are registered on ClinicalTrials.gov 12.
Sport (WADA)
Cagrilintide is not named on the WADA 2026 Prohibited List 15. Class S0 prohibits at all times any pharmacological substance not addressed elsewhere on the List and with no current approval by any governmental regulatory health authority for human therapeutic use, such as drugs under clinical development 15.

Status varies by country and changes over time. How we describe regulatory status.

Quality and testing notes

Cagrilintide is a 37-residue amylin analogue carrying an N-terminal C20 fatty diacid attached through a gamma-glutamyl linker and an intramolecular disulfide bond, with a PubChem molecular formula of C194H312N54O59S2 [14]. A certificate of analysis for reference material would typically show HPLC purity with chromatogram, intact mass by mass spectrometry against that formula, confirmation of the disulfide (for example by non-reduced versus reduced mapping), net peptide content, counter-ion and residual solvent content, and related-substance profiling for deamidation and oxidation. Because amylin analogues are prone to aggregation, data on aggregate or fibril content add value [7].

How purity testing works · Reading a certificate of analysis

Check a Cagrilintide certificate of analysis against its expected mass (4,409 Da)

Storage and handling

No approved-product storage instructions exist because cagrilintide has no FDA label. Handling of research material should follow the supplier's documentation and certificate of analysis, including temperature, light protection and freeze-thaw limits.

Frequently asked questions

Is cagrilintide FDA-approved?
No. An openFDA query returned no application record, and it remains under investigation in registered trials 12,13.
What is CagriSema?
CagriSema is the name used for the combination of cagrilintide and semaglutide studied in the REDEFINE and REIMAGINE trials 4,6.
Has cagrilintide been studied on its own?
Yes. A 26-week phase 2 trial tested five doses of cagrilintide alone, and later trials included cagrilintide-only arms 1,3,6.
What weight change was reported with cagrilintide alone?
In the phase 2 monotherapy trial, mean reduction was 6.0% to 10.8% across doses versus 3.0% with placebo at 26 weeks 1; in the 32-week type 2 diabetes trial, the cagrilintide arm changed by -8.1% 3.
How long does cagrilintide stay in the body?
Its half-life was 159 to 195 hours in a phase 1b trial 2.
Which receptors does it act on?
Amylin receptors AMY1R, AMY2R and AMY3R and the calcitonin receptor 8.
What adverse events were most common?
Gastrointestinal events such as nausea, constipation and diarrhoea, plus administration-site reactions 1.

Latest indexed research

Search all studies on Cagrilintide (PubMed, Europe PMC, ClinicalTrials.gov)

Listed by publication type from the index record. Inclusion is not an endorsement; open the source to read the findings.

Revision history

Meaningful changes to this entry, with dates and sources. Last reviewed Oct 23, 2026. Typo and layout fixes are not listed.

References

  1. 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
  2. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg for weight management: a randomised, controlled, phase 1b trial Lancet. 2021
  3. 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
  4. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1) N Engl J Med. 2025
  5. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (REDEFINE 2) N Engl J Med. 2025
  6. Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study Lancet Diabetes Endocrinol. 2026
  7. Development of Cagrilintide, a Long-Acting Amylin Analogue J Med Chem. 2021
  8. Structural and dynamic features of cagrilintide binding to calcitonin and amylin receptors Nat Commun. 2025
  9. Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3 EBioMedicine. 2025
  10. CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1 Hypertension. 2026
  11. Efficacy and Safety of Cagrilintide and Cagrisema Versus Semaglutide as Anti-Obesity Medications: A Systematic Review, Meta-Analysis and Meta-Regression Diabetes Obes Metab. 2026
  12. A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (REDEFINE 1, NCT05567796) ClinicalTrials.gov. 2026
  13. Drugs@FDA application data queried through openFDA for cagrilintide (no matching application record returned on 23 October 2026) openFDA / Drugs@FDA. 2026
  14. PubChem compound record for cagrilintide (CID 171397054; CAS 1415456-99-3) PubChem. 2026
  15. International Standard: Prohibited List 2026 World Anti-Doping Agency. 2026
  16. Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity (registry results: participant flow group descriptions) ClinicalTrials.gov. 2023

Last reviewed October 23, 2026 by the Amiravo editorial team.

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Unbranded reference vial illustrating Cagrilintide; not an actual product

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Specifications

Molecular formula
C194H312N54O59S2
Molecular weight
4,409 g/mol
CAS number
1415456-99-3
PubChem CID
171397054
Sequence
(C20 diacid-gamma-Glu)-KCNTATCATQRLAEFLRHSSNNFGPILPPTNVGSNTP-NH2 (lipidated N-terminus; disulfide between the two Cys residues; PubChem sequence string XKCNTATCATQRLAEFLRHSSNNFGPILPPTNVGSNTP)
Format
Lyophilized vial
Vial sizes seen
5 mg · 10 mg
Type
Single compound

Identifiers from PubChem. Verify against the supplier’s documentation for your lot.

Research stats

How much has been published, not how good it is.

PubMed records
122
Indexed as human research
77
Animal-only research
6
Randomized controlled trials
15
Registered trials
44
Trials with posted results
1
FDA adverse-event reports (FAERS)
4
NIH-funded projects naming it
4
2006: 02007: 02008: 02009: 02010: 02011: 02012: 02013: 02014: 02015: 02016: 02017: 02018: 02019: 02020: 02021: 82022: 62023: 72024: 192025: 382026: 5620062026
PubMed records per year (current year is partial).

Counts from title/abstract searches of PubMed, ClinicalTrials.gov, openFDA and NIH RePORTER, checked 2026-10-24. Names shared with other substances can inflate counts. FAERS reports are spontaneous and do not establish cause. Funding shows interest, not evidence. Method

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