Cagrilintide

Cagrilintide, developed by Novo Nordisk under the code AM833, is a long-acting analog of amylin, the hormone the pancreas releases alongside insulin to signal fullness.

Human trialsPeptide research profile

Also known as: AM833, Long-acting amylin analogue

(how we review)

Dosing & scaling, explained

Cagrilintide dosing remains investigational. Phase 2 research tested a broad weekly dose range with escalation. This is educational source context, not a protocol or recommendation.

How sourced amounts are organized

  1. Lower phase 2 arms0.3-0.6 mg / week26-week trial

    Lower maintenance arms in the dose-finding study.

  2. Mid phase 2 arms1.2-2.4 mg / weekAfter escalation

    Includes the 2.4 mg dose used in combination research.

  3. Highest phase 2 arm4.5 mg / weekAfter escalation

    Highest cagrilintide-only arm in the cited study; not an approved dose.

Patterns described in source material

  • Once weekly

    The clinical development program uses weekly administration.

  • Escalation

    The dose-finding trial included up to six weeks of dose escalation.

  • Combination-specific

    CagriSema schedules should not be interpreted as cagrilintide-only evidence.

Clinical context
  • 0.3-4.5 mgOnce weeklyPhase 2 dose-finding armsNCT03856047

Multiple doses have direct phase 2 human data, but the compound remains investigational.

Storage, handling and interpretation

Lyophilized material

Keep cold, dry, and protected from light according to the manufacturer certificate or validated lab SOP.

After reconstitution

Use sterile technique, refrigerate as validated, and avoid repeated freeze-thaw cycles.

Traceability

Record lot, concentration, preparation date, and the identity/purity documentation used by the lab.

Reported protocols for Cagrilintide

What published studies and recent community write-ups report about amounts, timing and course length. 6 clinical and 3 community-reported rows, each linked to its source. These are descriptions of what others report, not instructions, and nothing here is medical advice.

ContextDoseFrequencyRouteCourseSource
Clinical6 rows
Phase 2 dose-finding trial in obesity706 adults without diabetes with a BMI of 30 or more, or 27 or more with hypertension or dyslipidemia, at 57 sites in 10 countries0.3, 0.6, 1.2, 2.4 or 4.5 mg maintenance, started at 0.3 mg for the lowest arm and 0.6 mg for all the othersOnce weekly, stepped up every 2 weeksSubcutaneous self-injection with a pen26 weeks, including up to 6 weeks of escalation, then 6 weeks of follow-up without treatmentNone during treatment; the 6-week follow-up was for washoutThe Lancet (PubMed)2021
Weight fell 6.0%, 6.8%, 9.1%, 9.7% and 10.8% across the five doses against 3.0% on placebo, and 4.5 mg beat daily liraglutide 3.0 mg. Everyone also received diet and activity counselling aiming at a 500 kcal daily deficit. One in ten participants stopped treatment permanently, mostly for adverse events.
Phase 3 REDEFINE 1, cagrilintide alone arm302 of 3,417 adults with obesity or overweight plus a complication and without diabetes, in 22 countries2.4 mg maintenanceOnce weeklySubcutaneous68 weeksNoneNew England Journal of Medicine2025
This is the largest and longest look at cagrilintide by itself. Weight fell 11.8% at 68 weeks on the adherence-based analysis, against 16.1% for semaglutide alone, 22.7% for the combination and 2.3% for placebo. Gastrointestinal events affected 54.0% of the cagrilintide group against 39.9% on placebo, the lowest rate of any active arm.
Phase 3 REDEFINE 1, CagriSema combination2,108 adults with obesity or overweight plus a complication, mean starting weight 106.9 kg, without diabetes2.4 mg of cagrilintide with 2.4 mg of semaglutide in one fixed-dose penOnce weeklySubcutaneous68 weeksNone; investigators could reduce the dose on clinical judgmentNew England Journal of Medicine2025
Weight fell 20.4% by intention to treat and 22.7% on the adherence-based analysis, against 3.0% and 2.3% on placebo, and 50.7% of participants with obesity ended below a BMI of 30 from a mean starting BMI of 38. Gastrointestinal events hit 79.6% of this group against 39.9% on placebo, mostly transient and mild to moderate, and the authors note that some people did well on doses below the target.
Phase 3 REDEFINE 2 in type 2 diabetes1,206 adults with type 2 diabetes, a BMI of 27 or more and HbA1c between 7% and 10%, in 12 countries0.25 mg of each drug to start, then 0.5, 1.0 and 1.7 mg, reaching 2.4 mg of each after 16 weeksOnce weekly, stepped up every 4 weeksSubcutaneous, using a dual-chamber single-use pen16 weeks of escalation then 52 weeks of maintenance, with 7 weeks of follow-upNone; people who could not tolerate the target dose stayed on a lower one and were asked to try escalating again at least onceNew England Journal of Medicine2025
This is the published escalation ladder for the combination. Weight fell 13.7% by intention to treat and 15.7% on the adherence analysis against 3.4% and 3.1% on placebo, and 73.5% reached an HbA1c of 6.5% or less compared with 15.9% on placebo. Gastrointestinal events affected 72.5% against 34.4% on placebo.
Blood pressure analysis from REDEFINE 1Participants in REDEFINE 1 with a mean baseline systolic pressure of 127 mm Hg2.4 mg of cagrilintide with 2.4 mg of semaglutideOnce weeklySubcutaneous68 weeksNoneHypertension (PubMed Central)2026
Systolic pressure fell 10.9 mm Hg on the adherence-based analysis, a confirmatory secondary endpoint, and the paper notes that the blood pressure change happened early in the trial rather than tracking the weight curve. These are secondary and post hoc analyses of one trial.
Sponsor announcement of the REDEFINE 1 headline result3,417 randomized adults with obesity or overweight and at least one other condition2.4 mg of cagrilintide alone, 2.4 mg of semaglutide alone, or 2.4 mg of each in combinationOnce weeklySubcutaneous68 weeksNoneNovo Nordisk2024
Novo Nordisk's December 2024 release gives the four-way comparison in one place: 22.7% for the combination, 16.1% for semaglutide alone, 11.8% for cagrilintide alone and 2.3% for placebo on the adherence analysis. It also reports that 40.4% of the combination group lost 25% or more of their body weight, against 6.0% on cagrilintide alone.

How a course is commonly described

  1. Weeks 1-4: 0.25 mgClinical

    The published combination ladder opens at 0.25 mg of each drug once weekly and holds it for four weeks. The monotherapy trial instead started at 0.6 mg a week for every arm above the lowest, so there is no single-agent precedent for a 0.25 mg start.

  2. Weeks 5-16: 0.5, 1.0 then 1.7 mgClinical

    Three further four-week steps bring the dose to 1.7 mg, reaching the 2.4 mg maintenance dose after 16 weeks. Gastrointestinal effects cluster in this escalation window in both phase 3 trials and were mostly transient and mild to moderate.

  3. Week 17 onward: 2.4 mg maintenanceClinical

    Maintenance at 2.4 mg ran for 52 weeks to the week 68 endpoint. Participants who could not tolerate the target dose were kept in the trial on a lower one and asked to attempt escalation again at least once, and the authors suggest doses below the target may be enough for some people.

  4. Monotherapy comparisonClinical

    On its own, cagrilintide escalated every two weeks over up to six weeks to a maintenance dose of 0.3 to 4.5 mg, and the phase 2 trial ran 26 weeks. The single-agent arm of REDEFINE 1 held 2.4 mg for 68 weeks and produced 11.8% weight loss, roughly half the combination result.

  5. Community cyclingCommunity-reported

    Community charts run 8 weeks on and 8 weeks off, sometimes at 250 mcg three times a week, which adds up to well under a third of the weekly trial dose. No trial has tested any break: the phase 2 study dosed continuously for 26 weeks and the phase 3 trials for 68.

  • Cagrilintide has no approved label anywhere, either alone or as CagriSema, so the 16-week ladder to 2.4 mg is a trial protocol rather than a dosing recommendation. 4.5 mg once weekly is the highest dose any published trial has used, and that was in the 26-week phase 2 study.
  • The published escalation schedule belongs to the fixed-dose combination pen. No trial has titrated cagrilintide alone from 0.25 mg, and one community page states outright that the 0.25 to 4.5 mg single-agent ladder circulating online is a construction of those sites with no published source.
  • Gastrointestinal side effects are the dose-limiting problem and were far more common on the combination than on cagrilintide alone: 79.6% against 54.0% in REDEFINE 1, with 39.9% on placebo. Both phase 3 papers describe them as mostly transient and mild to moderate.
  • Trial participants used manufacturer-supplied drug in a metered pen with lifestyle support and scheduled dose reductions where needed. Material sold online as cagrilintide is unregulated, and community schedules of 250 mcg three times weekly deliver a fraction of the exposure any trial tested.
Sources for this section (9)
  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 trialThe Lancet (PubMed)2021Clinical
  2. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or ObesityNew England Journal of Medicine2025Clinical
  3. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 DiabetesNew England Journal of Medicine2025Clinical
  4. CagriSema demonstrates superior weight loss in adults with obesity or overweight in the REDEFINE 1 trialNovo Nordisk2024Clinical
  5. CagriSema demonstrates superior weight loss in adults with obesity or overweight and type 2 diabetes in the REDEFINE 2 trialNovo Nordisk2025Clinical
  6. CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1Hypertension (PubMed Central)2026Clinical

Plus 3 community resources (dosing guides, forum threads and vendor write-ups), reported above but not linked.

Overview

Cagrilintide, developed by Novo Nordisk under the code AM833, is a long-acting analog of amylin, the hormone the pancreas releases alongside insulin to signal fullness. A C20 fatty diacid attached through a glutamate linker extends its action to about a week, so it is given as a once-weekly subcutaneous injection. On its own it produced 6.0% to 10.8% weight loss at 26 weeks in a phase 2 dose-finding trial and 11.8% at 68 weeks in a phase 3 comparison arm. Its main development path is as half of CagriSema, a fixed-dose combination with semaglutide in one pen, which produced 22.7% weight loss at 68 weeks in adults without diabetes and 15.7% in adults with type 2 diabetes on the adherence-based analysis. Neither cagrilintide alone nor CagriSema is approved, so there is no label and no approved dosing schedule.

What researchers are exploring

These themes describe recurring questions in published research. They are not claims of effectiveness or recommendations for use.

  • 1

    Weight management

    A phase 2 dose-finding trial compared five weekly doses with placebo and liraglutide.

  • 2

    Appetite signaling

    Amylin pathways influence satiation and gastric emptying.

  • 3

    Combination research

    CagriSema studies combine cagrilintide with semaglutide.

  • 4

    Dose escalation

    Trials use escalation to reach maintenance exposures and manage tolerability.

What the current evidence can support

Study models remain visible so laboratory and animal findings are not mistaken for established human outcomes.

  • Human

    Phase 2 dose-finding trial

    Weekly 0.3, 0.6, 1.2, 2.4, and 4.5 mg arms were studied for 26 weeks.

  • Human

    CagriSema phase 2 trial

    Cagrilintide 2.4 mg was studied with semaglutide 2.4 mg in type 2 diabetes.

  • Review

    Investigational status

    No cagrilintide-only product has an approved public dosing label.

Amounts recorded for Cagrilintide

These amount records are independent from vial strength, reconstitution volume and measuring device. A recorded source is not the same as study backing, and these values are not recommendations.

  • 1
    Lower phase 2 armSign in for schedule, duration and source context.
    0.3 mg
  • 2
    Mid phase 2 armSign in for schedule, duration and source context.
    2.4 mg
  • 3
    Published phase 2 capSign in for schedule, duration and source context.
    4.5 mg

Chemistry identifiers

Sequence, synonyms and registry identifiers as recorded in PubChem, the National Library of Medicine's open chemistry database. Formula, mass and CAS number are summarized at the top of the page.

Sequence

Lys(C20 diacid-gamma-Glu)-Cys-Asn-Thr-Ala-Thr-Cys-Ala-Thr-Gln-Arg-Leu-Ala-Glu-Phe-Leu-Arg-His-Ser-Ser-Asn-Asn-Phe-Gly-Pro-Ile-Leu-Pro-Pro-Thr-Asn-Val-Gly-Ser-Asn-Thr-Pro-NH2 (cyclic disulfide between the cysteines at positions 3 and 8 of the amylin numbering)

Also listed as

Cagrilintide [INN], AM833, NNC0174-0833, UNII AO43BIF1U8, GTPL13768, EX-A10092

InChIKey

LDERDVMBIYGIOI-IZVMHKDJSA-N

Origin / design

Engineered for prolonged amylin-receptor activity

IUPAC name

20-[[(1S)-4-[[(2S)-6-amino-1-[[(4R,7S,10S,13S,16S,19R)-4-[[(2S)-1-[[(2S,3R)-1-[[(2S)-5-amino-1-[[(2S)-1-[[(2R)-1-[[(2R)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(2S)-4-amino-1-[[(2S)-1-[[2-[(2S)-2-[[(2S,3S)-1-[[(2R)-1-[(2R)-2-[(2R)-2-[[(2R,3S)-1-[[(2R)-4-amino-1-[[(2R)-1-[[2-[[(2R)-1-[[(2R)-4-amino-1-[[(2R,3S)-1-[(2R)-2-carbamoylpyrrolidin-1-yl]-3-hydroxy-1-oxobutan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-2-oxoethyl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]carbamoyl]pyrrolidine-1-carbonyl]pyrrolidin-1-yl]-4-methyl-1-oxopentan-2-yl]amino]-3-methyl-1-oxopentan-2-yl]carbamoyl]pyrrolidin-1-yl]-2-oxoethyl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-3-(1H-imidazol-4-yl)-1-oxopropan-2-yl]amino]-5-carbamimidamido-1-oxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-carboxy-1-oxobutan-2-yl]amino]-1-oxopropan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-5-carbamimidamido-1-oxopentan-2-yl]amino]-1,5-dioxopentan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-1-oxopropan-2-yl]carbamoyl]-16-(2-amino-2-oxoethyl)-7,13-bis[(1R)-1-hydroxyethyl]-10-methyl-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicos-19-yl]amino]-1-oxohexan-2-yl]amino]-1-carboxy-4-oxobutyl]amino]-20-oxoicosanoic acid

Limitations and unknowns

Important limitations

  • Combination-trial results cannot be attributed to cagrilintide alone.
  • The calculator preset is not a substitute for the escalation used in trials.
  • A calculator preset is a recorded research convention, not a recommendation or evidence of clinical benefit.
  • Identity, purity, sterility, and stability can vary substantially outside regulated manufacturing.
  • Route, formulation, and population can make results from one study inapplicable to another use.

Sources

2 curated references, each with its journal, year and study model, plus 3 community resources reported but not linked.

  1. Once-weekly cagrilintide for weight management in people with overweight and obesityThe Lancet2021Human
  2. Efficacy and safety of co-administered cagrilintide with semaglutide in type 2 diabetesThe Lancet2023Human