The Amylin Half of CagriSema
Cagrilintide
Also known as AM833
At a glance
- What it is
- Long-acting amylin agonist. Investigational alone; studied as half of CagriSema.
- Evidence
- Clinical trialsHow the tiers workCagrilintide has genuine Phase 3 trial data, almost all of it as half of CagriSema rather than as a standalone agent: REIMAGINE 3 (NCT06323161) completed in October 2025, with further Phase 3 trials recruiting including a paediatric study, on top of the REDEFINE programme. Why this tier
- Routes
- Subcutaneous
- Category
- Metabolic
- WADA
- We do not state a status
Putting Cagrilintide on a schedule, with the vial it comes from and a log of each dose, happens in the app: Claritide for iPhone.
Why this tier
Cagrilintide has genuine Phase 3 trial data, almost all of it as half of CagriSema rather than as a standalone agent: REIMAGINE 3 (NCT06323161) completed in October 2025, with further Phase 3 trials recruiting including a paediatric study, on top of the REDEFINE programme. Two claims circulating about it are wrong: cagrilintide plus tirzepatide is not a combination product (those trials are CagriSema-versus-tirzepatide head-to-head comparators), and cagrilintide plus retatrutide does not exist in the trial registry at any phase.
What it is
Cagrilintide is a long-acting amylin receptor agonist that suppresses appetite through a pathway distinct from GLP-1. It has no US label, since a drug label database query returns nothing, so it cannot be prescribed in the United States. Its significance is as the amylin half of CagriSema, the only combination in this landscape with genuine Phase 3 data behind the combination itself.
How it works
Amylin is a hormone co-secreted with insulin by pancreatic beta cells, and its job is meal termination: it signals that enough has been eaten, slows gastric emptying and suppresses glucagon release after a meal. Cagrilintide is a long-acting analogue that engages the same receptors on a weekly rather than a meal-by-meal timescale. That is a different appetite pathway from GLP-1, which is the entire rationale for combining the two: two independent brakes rather than one applied harder. Cagrilintide’s pharmacokinetics are unaffected by renal or hepatic impairment, which is an unusually clean profile for a weekly injectable.
Commonly researched ranges
- Phase 2 monotherapy dose-finding arms0.3–4.5 mg
Lau et al., Lancet 2021 (NCT03856047) randomised five doses: 0.3, 0.6, 1.2, 2.4 and 4.5 mg weekly. Those five are the ladder, and there are no steps between them: 0.3, 0.6, 1.2 and 4.5 are literal trial arms rather than tidy numbers, and none of them may be rounded. Investigational; cagrilintide is not approved anywhere.
- Trial dose in CagriSema (REIMAGINE 3, Phase 3)2.4 mg
Given as cagrilintide 2.4 mg with semaglutide 2.4 mg from a dual-chamber pen, with a 1.0 mg / 1.0 mg arm alongside it. NCT06323161 completed in October 2025. This is a trial regimen for a combination product, not a standalone protocol.
| Phase | Amount | Frequency | Timing | Note |
|---|---|---|---|---|
| Phase 2 monotherapy dose-finding arms | 0.3–4.5 mg | Once weekly for 26 weeks | Not established in available literature | Lau et al., Lancet 2021 (NCT03856047) randomised five doses: 0.3, 0.6, 1.2, 2.4 and 4.5 mg weekly. Those five are the ladder, and there are no steps between them: 0.3, 0.6, 1.2 and 4.5 are literal trial arms rather than tidy numbers, and none of them may be rounded. Investigational; cagrilintide is not approved anywhere. |
| Trial dose in CagriSema (REIMAGINE 3, Phase 3) | 2.4 mg | Once weekly | Not established in available literature | Given as cagrilintide 2.4 mg with semaglutide 2.4 mg from a dual-chamber pen, with a 1.0 mg / 1.0 mg arm alongside it. NCT06323161 completed in October 2025. This is a trial regimen for a combination product, not a standalone protocol. |
- Cycle guidance
- Not cycled. The trial programmes run continuous weekly dosing, as with the rest of the incretin class.
- Goals
- Fat loss
Where this sits with the FDA
A query of the US drug label database for cagrilintide returns zero results. There is no US label, so despite what several pages state, it cannot be prescribed in the United States. It is an investigational compound in an active Phase 3 programme.
Primary sourceWADA status
Not named on the 2026 Prohibited List. Semaglutide and tirzepatide sit on the Monitoring Program rather than the Prohibited List; we could not determine cagrilintide’s classification and do not state one.
We looked and could not resolve it. This is not the same as "not prohibited". Treat it as unresolved and check with your federation before competing.
Mixing recipes our sources document
Not established in available literature. Use the calculator with the figures printed on your own vial.
Open the calculator
Week by week
Not established in available literature.
Side effects
Not established in available literature. Absence from this page does not mean absence of risk. It means our sources publish no side-effect profile for Cagrilintide.
Contraindications and interactions
Do not use if
Not established in available literature.
Interactions
Not established in available literature.
Absence from this list does NOT mean safety. It means lack of research.
Storage and cost
- Storage
- The clinical formulation is a dual-chamber pen delivering a solution, not a reconstituted vial. Our sources publish no vial and diluent pairing for cagrilintide as a standalone compound, so we publish none.
- Cost
- Not established in available literature
Stacks with
Curated stacks including it
Cagrilintide in full
What it is
Cagrilintide is a long-acting amylin receptor agonist. Amylin is a hormone released alongside insulin from pancreatic beta cells, and its role is meal termination, the signal that says enough. It also slows gastric emptying and suppresses glucagon after eating.
That is a genuinely different appetite pathway from GLP-1. Which is the whole point.
Why it matters
Every other combination in this landscape is a community stack: two compounds someone decided to run together, with no study of the pair. CagriSema is the exception. Cagrilintide and semaglutide are being developed as a single product, in a dual-chamber pen, with Phase 3 trials of the combination itself.
REIMAGINE 3 (NCT06323161) ran cagrilintide 2.4 mg with semaglutide 2.4 mg once weekly, alongside a 1.0 mg / 1.0 mg arm, and completed in October 2025. Further Phase 3 trials are recruiting, including NCT07564414 and a paediatric study, NCT07253285. The earlier REDEFINE programme covers NCT05567796, NCT05669755 and NCT06388187.
In the BMJ network meta-analysis of the whole weight-loss class, CagriSema sits near the top at about 14.8% weight loss at one year, effectively level with tirzepatide.
Two claims to correct
Cagrilintide plus tirzepatide is not a combination. A full sweep of 40 cagrilintide studies shows the tirzepatide trials, NCT06131437, NCT06221969 and NCT06534411, are CagriSema versus tirzepatide head-to-head comparisons. Reading a comparator arm as a combination is an easy error and it inverts the design.
Cagrilintide plus retatrutide does not exist. Not at any phase, in any registry entry we could find.
On availability
A query of the US structured product label database for cagrilintide returns zero results. There is no US label. It cannot be prescribed in the United States, whatever a telehealth page says.
It is worth noting how the dosing figures on this page were found, because it is a small lesson in sourcing. An earlier pass reported cagrilintide dosing as unverifiable because a vendor page said "coming soon". That is treating a vendor's editorial backlog as evidence of absence. The trial registry had the doses all along, publicly, with trial identifiers attached.
Pharmacokinetics
Cagrilintide exposure is unaffected by renal or hepatic impairment, an unusually clean profile that matters for a weekly injectable, because it removes a whole category of dose adjustment. Half-life could not be located in our sources and is therefore null rather than estimated.
What to do with this record
Nothing, practically. There is no legitimate way to obtain cagrilintide in the United States, and the dose figures on this page belong to a two-drug combination delivered from a dual-chamber pen, not to a standalone vial someone reconstitutes.
The reason to read it is comparative. When a community stack claims that two compounds work better together, ask what evidence exists for the pair rather than for each part. Almost always the answer is none: two individually studied compounds put in the same syringe by someone who liked the reasoning. CagriSema is what the alternative looks like: a specific ratio, in a specific device, tested against its own components in a randomised trial with a registry entry you can read.
That is the standard, and it is worth knowing what it looks like so you can notice when something falls short of it.
Sources
- 1NCT06323161 · REIMAGINE 3, Phase 3 CagriSema, COMPLETED October 2025
- 2DailyMed query for cagrilintide · total_elements: 0
- 3Lau et al., Lancet 2021 · Phase 2 monotherapy dose-finding: 0.3, 0.6, 1.2, 2.4 and 4.5 mg weekly (dose review, 2026-08-17)
- 4NCT03856047 · the registry entry for that dose-finding trial (dose review, 2026-08-17)
Every record in this library is free to read, and it stays free. Your own schedule, vials and log live in the app: Claritide for iPhone.