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Cagrilintide

Also known as AM833, NNC0174-0833

Long-acting amylin analogue that enhances satiety, studied alone and with semaglutide.

early-clinical Metabolic & weight research chemical

At a glance

Category
Metabolic & weight
Status
research chemical
Route
subcutaneous, once weekly
Half-life
159-195 hours (6.6-8.1 days) across doses of 0.16 to 4.5 mg, with a median tmax of 24-72 hours — consistent with weekly dosing 6
Onset
weight loss from a few weeks onwards
Molecular weight
approximately 3900 g/mol; not published in a figure we could verify against a primary source
Sequence
32-amino-acid analogue of human amylin (IAPP), with substitutions for solubility and anti-aggregation and a fatty acid side chain for albumin binding

Not registered as monotherapy anywhere. Novo Nordisk is developing it in a fixed combination with semaglutide (CagriSema, cagrilintide 2.4 mg with semaglutide 2.4 mg), and on 18 December 2025 the company submitted a New Drug Application to the FDA for that combination for weight management in adults with obesity, or overweight with at least one weight-related comorbidity; the company's own announcement states that CagriSema is not approved in the US or EU 5. The FDA states separately that cagrilintide cannot be used in compounding under federal law, is not a component of any FDA-approved drug, and has not been found safe and effective for any condition 2.

Doping status: Prohibited (WADA S0, non-approved substances)

Checked against the WADA 2026 Prohibited List. For a specific product and country, Global DRO is the lookup athletes are expected to use — the List names substances, not brand names.

Mechanism of action

Cagrilintide is an analogue of amylin (islet amyloid polypeptide, IAPP), a hormone secreted together with insulin by the beta cells of the pancreas after a meal. Amylin acts on the amylin receptors — complexes of the calcitonin receptor with receptor-activity-modifying proteins (RAMP1-3) — in the area postrema and the nucleus tractus solitarii of the brainstem.

Activation of these receptors produces a satiety signal, slows gastric emptying and inhibits postprandial glucagon release. The satiety mechanism differs from that of GLP-1: amylin acts mainly on the size of a meal (satiation) via the brainstem, whereas GLP-1 acts more broadly on appetite and reward behaviour. As a result the effects of the two classes are additive.

Natural human amylin is highly prone to aggregation and forms amyloid fibrils, which made therapeutic use impossible. Cagrilintide has amino acid substitutions that counter aggregation and a fatty acid chain that provides reversible albumin binding; together these yield a half-life of about a week, against minutes for natural amylin. The older drug pramlintide, by contrast, required three injections a day.

What the research shows

The evidence consists of phase 1 and phase 2 studies with cagrilintide as monotherapy and of phase 2 and phase 3 studies of the combination with semaglutide. As a standalone agent the reported effect size is modest compared with modern GLP-1 drugs; clinical development is focused almost entirely on the combination.

Research in humans

The phase 2 dose-finding study (Lancet 2021, n=706, 26 weeks) reported a mean weight loss with cagrilintide monotherapy of approximately 10.8% at the highest dose of 4.5 mg per week versus approximately 3.0% with placebo, with 6.0% at the lowest dose of 0.3 mg; liraglutide 3.0 mg served as active control and produced 9.0%. Note that 4.5 mg is nearly double the 2.4 mg dose carried into the CagriSema combination. In phase 2 combination studies, cagrilintide added to semaglutide 2.4 mg produced more weight loss than semaglutide alone. The phase 3 REDEFINE programme with CagriSema reported weight reductions on the order of approximately 20-23% in participants without diabetes and lower in participants with type 2 diabetes.

Animal and lab research

Preclinical research with amylin analogues supports the satiety effect via the area postrema and the additive effect when combined with GLP-1 agonism.

Caveats. All studies were funded and conducted by Novo Nordisk. Virtually all recent data concern the combination with semaglutide, which makes the contribution of cagrilintide alone hard to isolate. The REDEFINE results fell short of the expectations the company had voiced beforehand. Long-term safety data and cardiovascular outcomes are lacking. There are no published studies of cagrilintide monotherapy as a standalone treatment beyond phase 2.

What it is used for

  • Studied for obesity and overweight, both as monotherapy in a 26-week phase 2 dose-finding trial 1 and, mainly, in fixed combination with semaglutide (CagriSema) 5
  • Studied for type 2 diabetes in combination with semaglutide (REIMAGINE programme)
  • Used outside a study setting via the grey market, often in self-mixed combinations with semaglutide or tirzepatide; this practice has not been studied and is not controlled

Dosing

Dose
0.3, 0.6, 1.2, 2.4 or 4.5 mg per week in phase 2 monotherapy; 2.4 mg per week is the dose in the CagriSema combination
Frequency
Once weekly
Route
Subcutaneous
Duration
26 weeks in the phase 2 study; longer in phase 3. The optimal treatment duration has not been established
  • The phase 2 dose-finding trial randomised 706 participants over 26 weeks to cagrilintide 0.3, 0.6, 1.2, 2.4 or 4.5 mg once weekly, placebo, or liraglutide 3.0 mg as active control 1; the CagriSema combination fixes cagrilintide at 2.4 mg weekly 5. In that study the dose was titrated over several weeks to the final dose to limit nausea; the exact titration steps differed per study arm. Gastrointestinal adverse events occurred in 41-63% of cagrilintide recipients against 32% on placebo, and nausea in 20-47% against 18%, which is what the escalation is for 1.
  • In CagriSema, cagrilintide and semaglutide are both titrated to 2.4 mg per week in a single combined administration.
  • There is no approved dosing schedule for cagrilintide on its own, because it is not approved anywhere as monotherapy 25. What is stated here is a description of study doses, not a usage instruction.
  • Doses circulating in online user protocols are not clinically validated, and self-mixing with a GLP-1 drug has been studied neither pharmaceutically nor clinically.
  • Cagrilintide is not a licensed product in any form, yet it is sold as lyophilised powder in vials online and is reconstituted and self-injected. The FDA states that cagrilintide cannot be used in compounding under federal law, is not a component of any FDA-approved drug, and has not been found safe and effective for any condition 2. Trial participants receive a sponsor-prepared solution; the powder is a separate, unapproved supply route with nothing in common but the molecule name.
  • The milligram-versus-microgram trap is the single most likely way someone is harmed with this compound, and it bites harder here than with the incretins because the doses are smaller. A 0.3 mg starting dose is 300 micrograms — a factor of a thousand separates the units — and 'units' on an insulin syringe is a volume (1 unit = 0.01 ml), not a dose, so the same unit count means a different milligram amount at every concentration. The FDA's compounding risk alert of 26 July 2024, describing this exact vial-and-syringe failure mode for semaglutide, records patients self-administering five to twenty times the intended dose, and reports that patients instructed to draw a 5-unit (0.05 ml) dose on a U-100 syringe mistakenly administered 50 units instead 3.
  • Grey-market powder carries no guarantee of identity, purity, sterility or actual milligram content, so the number on the label may not be the number in the vial, and any calculation is only as good as that label. There is no licensed cagrilintide product anywhere against which a vial could be compared.
  • The trial titration schedules exist because gastrointestinal effects are dose-limiting — gastrointestinal disorders were the most common adverse events in the phase 2 study, reported by 41-63% of cagrilintide recipients versus 32% on placebo 1, and were strongest during escalation. Starting at a maintenance dose rather than titrating is how people end up vomiting for days and dehydrated. With a half-life of roughly a week, an overdose does not resolve overnight.
  • Self-mixing cagrilintide with semaglutide or tirzepatide in one syringe, which circulates as a practice, compounds the arithmetic problem: two unverified powders, two concentrations and two milligram targets drawn into one barrel, with no compatibility or stability data for the mixture.
  • The user schedule recorded in the protocols section below is a social fact, not a validated regimen: the figures are copied from the approved semaglutide and CagriSema titration ladders by analogy rather than derived from any study of cagrilintide dosed this way, and where reports diverge they do so precisely because nothing published anchors them.

These figures describe what the literature and published protocols report. They are not advice and not a dosing instruction.

Protocols

Cagrilintide monotherapy escalation to 4.5 mg (NCT05804162)

published trial

Source: ClinicalTrials.gov record NCT05804162 (cardiac safety study, Novo Nordisk)

Start0.6 mg subcutaneously once weekly
Escalation, 8 weeksdose increased once every 2 weeks
Target maintenance dose4.5 mg once weekly

A cardiac safety study, not an efficacy trial. The registry gives the starting dose, the escalation interval and the target but not the intermediate doses, so they are left out rather than guessed. The phase 2 weight-management trial used a dose-escalation period of up to 6 weeks to reach targets between 0.3 mg and 4.5 mg weekly, again without publishing the intervening steps.

CagriSema escalation in a phase 3 obesity trial (NCT05813925)

published trial

Source: ClinicalTrials.gov record NCT05813925 (CagriSema 2.4 mg/2.4 mg, Novo Nordisk)

Weeks 0-40.25 mg cagrilintide + 0.25 mg semaglutide subcutaneously once weekly
Weeks 5-80.5 mg cagrilintide + 0.5 mg semaglutide once weekly
Weeks 9-121 mg cagrilintide + 1 mg semaglutide once weekly
Weeks 13-161.7 mg cagrilintide + 1.7 mg semaglutide once weekly
Week 17 onward2.4 mg cagrilintide + 2.4 mg semaglutide once weekly (maintenance)

This is the schedule for the fixed combination, not for cagrilintide on its own: the two components are titrated together in a single injection, on the same four-week ladder Wegovy uses for semaglutide alone. It cannot be reproduced by mixing two separately bought powders, because neither component can then be adjusted independently.

Commonly reported user schedule (weekly subcutaneous)

user protocol — not validated

Source: User reports on peptide and GLP-1 forums together with vendor vial labelling

This is not a validated schedule. It is a pattern that circulates among users and sellers, reproduced because it is what people actually follow — not because it has been tested. No trial established these doses, this interval or this duration, and nobody is checking what is in the vial. Treat every number below as an assertion, not a finding.

Reported startcommonly 0.25-0.5 mg once weekly, a figure copied from the semaglutide (Wegovy) starting ladder rather than taken from any cagrilintide study
Reported escalationstepped up every 2-4 weeks, again mirroring the GLP-1 titration people already know
Reported maintenancemost often 2.4 mg once weekly, copied from the CagriSema dose; some push toward the 4.5 mg used in the phase 2 monotherapy arm
Reported cycle lengthrun continuously or for a few months; no consistent off-period is described

These figures come from user reports and vendor labelling and have no published pharmacokinetic or safety basis for cagrilintide used this way. The tell that the numbers are guessed by analogy is that they track the approved GLP-1 ladders — Wegovy's 0.25 mg start, the 2.4 mg CagriSema maintenance — rather than anything from a cagrilintide trial, and users openly disagree over whether to stop at 2.4 mg or climb to the 4.5 mg seen in the phase 2 monotherapy study 1. Because the doses are small, the milligram-versus-microgram error is the most dangerous part: 0.3 mg is 300 mcg, and a syringe 'unit' is a volume, not a dose. A common further step is self-mixing cagrilintide with semaglutide or tirzepatide in one barrel to reproduce a CagriSema-like combination, for which there are no compatibility, stability or dosing data at all.

Schedules are reproduced as their source states them. Units, IU and milligrams explains why the figures are not interchangeable between products.

Reconstitution

Vial sizes
5 mg, 10 mg
Solvent
bacteriostatic water (0.9% benzyl alcohol)
Storage
No approved storage instruction exists, because there is no approved product. Amylin analogues are sensitive to aggregation and pH; cagrilintide was specifically engineered to resist fibrillation, but the stability of unregistered powder before or after reconstitution has not been publicly studied.

Worked example

Two supply routes, kept apart. Clinical studies use a ready-to-use solution prepared by the manufacturer and participants reconstitute nothing; there is no registered product and no validated reconstitution protocol. What circulates online is lyophilised powder, reconstituted and measured by the buyer, and the arithmetic for such a vial runs: 5 mg vial + 2 ml bacteriostatic water = 2.5 mg/ml. A 0.3 mg (300 mcg) dose is 0.12 ml, which is 12 units on a U100 insulin syringe; the 2.4 mg dose used in the CagriSema combination would be 0.96 ml, or 96 units — almost the entire barrel, which is a signal that the concentration is wrong for that dose rather than a licence to fill the syringe. Reconstituting a 10 mg vial with the same 2 ml gives 5 mg/ml, at which those 12 units deliver 0.6 mg — double the intended dose from an identical syringe reading.

Vial strengths are not standardised between sellers: 5 mg and 10 mg both circulate, and the difference is invisible from the outside, so concentration must be recalculated for every vial and a unit figure copied from another protocol is meaningless. The worked example is descriptive arithmetic, not a protocol. It changes nothing about the starting material, whose identity, purity, sterility and actual milligram content are unverified, and self-mixing with another peptide in the same syringe has never been tested for compatibility.

Work it out for Cagrilintide

Safety

Side effects

  • Nausea and vomiting — the most frequently reported side effects, dose-dependent and strongest during titration; nausea affected 20-47% of cagrilintide recipients across dose groups against 18% on placebo in the phase 2 trial 1
  • Reduced appetite, constipation, diarrhoea, dyspepsia
  • Injection site reactions, described as administration-site reactions in the phase 2 trial 1
  • Fatigue
  • In the CagriSema studies the gastrointestinal side effects occurred more often than with semaglutide alone
  • Loss of fat-free mass with rapid weight loss
  • Rare and late side effects are unknown because of the limited duration of exposure
  • Overdose from a dosing error with reconstituted powder: the adverse events the FDA recorded after such errors with compounded semaglutide were nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis and gallstones 3. With a half-life of roughly a week, the effects of a tenfold error run for days rather than hours
  • Injection-site infection and abscess from non-sterile technique or non-sterile starting material

Do not use if

  • Hypersensitivity to amylin analogues
  • Pregnancy, breastfeeding and wish to conceive
  • Severe gastrointestinal disorders including gastroparesis — amylin slows gastric emptying, and confirmed gastroparesis is a labelled contraindication for the older amylin analogue pramlintide 7
  • Caution with insulin use: the older amylin analogue pramlintide carries a boxed warning stating that its use with insulin increases the risk of severe hypoglycaemia, particularly in type 1 diabetes, and its label requires mealtime insulin to be cut by 50% on initiation 7
  • Use outside clinical studies: no body guarantees the identity, strength or sterility of the product
  • Reconstituting and measuring unregulated powder without being able to do the milligram-to-unit conversion reliably. Errors at this step are the most frequently documented mechanism of harm with these compounds, and the FDA has recorded adverse events including hospitalisations from them 3
  • Any assumption that a grey-market vial contains what its label states. There is no licensed cagrilintide product anywhere, so no verified reference material exists and the label is the only claim there is

Interactions

Not systematically studied for cagrilintide. On the basis of the class, amylin analogues slow gastric emptying and can thereby affect the rate of absorption of oral medication: the pramlintide label states that it slows gastric emptying and may delay the absorption of concomitantly administered oral medicines, and directs that drugs needing a rapid onset be taken at least one hour before or two hours after the injection 7. With that same pramlintide, combination with insulin carries a boxed warning for severe hypoglycaemia and a required 50% reduction of mealtime insulin at initiation 7; whether this also applies to cagrilintide has not been established. The combination with semaglutide has been extensively studied and amplifies both the weight effect and the gastrointestinal side effects.

Common questions

What is cagrilintide?
Cagrilintide is a long-acting amylin analogue — amylin is a gut and pancreatic hormone that promotes fullness. It is studied for weight loss, both on its own and combined with semaglutide.
What is CagriSema?
CagriSema is the fixed combination of cagrilintide with semaglutide (a GLP-1 agonist), pairing two appetite mechanisms in one weekly injection. See the GLP-1 hub.
Is cagrilintide approved?
No — it is an experimental compound in clinical trials, not an approved medicine. Powder sold online is an unapproved research chemical. See legal status.

Sources