Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-25. ← Back to Evidence Library
Cagrilintide: what the evidence says
At a glance
What it is: an experimental lab-made version of amylin, a hormone the pancreas releases after meals that helps you feel full. Its maker, Novo Nordisk, is mainly developing it together with semaglutide as a combination called CagriSema (see CagriSema). R1, R2
What the evidence says: on its own, one mid-size phase 2 trial (706 people on cagrilintide) found more weight loss than placebo (a dummy treatment). Evidence for cagrilintide alone in type 2 diabetes is one small trial arm. All trials were funded by the maker. R1, R5
Biggest risks: stomach side effects (mainly nausea) and injection-site reactions in trials. Anything bought outside a trial is of unknown identity, strength and purity. R1, R7, R9
| Human Human evidence (weight, cagrilintide alone) | Limited: one phase 2 RCT (randomized controlled trial) in 706 people on cagrilintide plus 101 on placebo, funded by Novo Nordisk; larger trials tested it mostly as part of CagriSema R1 |
| Human Human evidence (type 2 diabetes, cagrilintide alone) | Very limited: one small comparison arm (30 people) in a phase 2 trial R5 |
| Animal Animal evidence | Not rated here |
| Regulatory | Not FDA-approved · cannot be used in compounding (FDA) · FDA has warned online sellers of "research" cagrilintide R7, R8, R9 · EU, UK, Japan, China: UNVERIFIED no approval found, not checked against EMA/PMDA/NMPA · WADA: not named; S0 (unapproved substances) likely applies R11 |
| Established human dose | None. There is no label. Trial study arms are listed only in Study details |
Evidence verdict: Human (weight, alone): Limited · Human (type 2 diabetes, alone): Very limited · Animal: not rated here Card verdict: Limited (weight, alone) · Type 2 diabetes (alone): Very limited Card note: Varies by use, see page
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
What is it?
Cagrilintide is a long-acting amylin analogue, meaning a lab-made peptide built to act like the natural hormone amylin, but to last much longer in the body. Natural amylin is released by the pancreas along with insulin and helps you feel full. R1 In trials it is injected under the skin. R1, R2
Does it work?
All results below come from trials funded by Novo Nordisk.
- Human Weight (cagrilintide alone, phase 2): in 706 adults with obesity or overweight and no diabetes, average weight loss was 6.0% to 10.8% across the cagrilintide study arms vs 3.0% on placebo. The highest arm also lost a bit more weight than liraglutide (an approved GLP-1 drug): 10.8% vs 9.0%. R1
- Human Type 2 diabetes (cagrilintide alone): in a 92-person phase 2 trial, the 30 people on cagrilintide alone had a smaller drop in HbA1c (average blood sugar) than people on semaglutide or on the combination (0.9 points vs 1.8 and 2.2), and lost 8.1% of body weight. R5
- Unknown Large phase 3 trials (REDEFINE 1, REIMAGINE 2) included a cagrilintide-alone group, but their published summaries do not report those groups' results. We have not been able to check the full texts. R4, R6
- Human Most of the evidence on cagrilintide is as part of CagriSema. See CagriSema.
Is it safe?
What trials reported:
- Caution Stomach side effects were the most common. In the phase 2 trial, 41% to 63% of people on cagrilintide had stomach-related side effects vs 32% on placebo, mainly nausea (20% to 47% vs 18%). R1
- Caution Injection-site reactions were also among the most common side effects. R1
- Caution Stopping early: 10% of all participants stopped treatment permanently, at similar rates across groups, mostly because of side effects (4% overall). R1
- Human Heart rhythm: a study in 105 healthy people found no meaningful effect on the QT interval (a heart-rhythm measure linked to dangerous arrhythmias). R3
- Unknown Long-term safety and rare harms of cagrilintide alone. The only published trial of cagrilintide alone was short (see Study details).
Gray-market "research use only" cagrilintide: extra risks
- Illegal "research" labels and unknown quality. FDA has sent warning letters to websites selling cagrilintide labeled "for laboratory research purposes only" or "not intended for human use," noting their marketing showed the products were meant for people, and advises consumers not to buy unapproved products of unknown quality that may be harmful. R7, R8, R9
- Measuring mistakes. FDA's reports of people drawing up the wrong amount from multi-dose vials involved compounded semaglutide, and the same syringe-marking problem applies to any vial you mix and measure yourself. See the measuring-mistakes section on our semaglutide page. R10
What we don't know
- Unknown What is actually in a given gray-market vial (identity, strength, sterility)
- Unknown Results for the cagrilintide-alone groups in the phase 3 trials
- Unknown Long-term safety of cagrilintide on its own
- Unknown Effects in people who were not studied (for example, pregnancy)
Is it legal?
Not FDA-approved for any use, and it cannot be used in compounding under federal law (FDA, page current as of Oct 1, 2026). R7 FDA has warned online sellers of cagrilintide. R9 The combination product CagriSema is under FDA review according to its maker UNVERIFIED; see CagriSema. Status in the EU, UK, Japan and China: UNVERIFIED not checked against EMA, PMDA or NMPA. WADA: not named on the 2026 Prohibited List; S0 bans at all times any unapproved substance in development that no other section covers, which describes Cagrilintide R11. WADA has not ruled on Cagrilintide by name. As of Oct 24, 2026.
What's in the vial?
There is no approved cagrilintide, so there is no reference product to compare a gray-market vial with. We have not found published lab tests of gray-market cagrilintide vials. Unknown Under the Open Peptide Standard, a vial is checked for identity, purity, amount per vial and endotoxin (draft). See results at /tests/. A passing test covers one batch, tested on one date. It does not mean the compound itself is safe.
What do users report?
Self-report, not evidence.
Unknown TBD. We'll only list this once we can cite a public source.
Study details
These are doses researchers used, not recommendations.
R1 Human: Phase 2, cagrilintide alone for weight (Lau 2021)
Funded by Novo Nordisk. 706 people on cagrilintide (100–102 per arm), 99 on liraglutide, 101 on placebo; adults without diabetes, BMI 30+ or 27+ with high blood pressure or high cholesterol. NCT03856047. Trial-product estimand (assumes everyone kept taking treatment).
| Study | People | Route | Dose used | Follow-up | Reported | Side effects / dropouts | Citation |
|---|---|---|---|---|---|---|---|
| Lau 2021, arm 1 | ~100 | Subcutaneous | Cagrilintide 0.3 mg once weekly | 26 wk treatment + 6 wk off-drug follow-up | Weight loss within the 6.0%–10.8% range across arms; per-arm value not in abstract | GI events 41%–63% across arms vs 32% placebo | PMID 34798060 |
| Lau 2021, arm 2 | ~100 | Subcutaneous | Cagrilintide 0.6 mg once weekly | Same | Within 6.0%–10.8% range; per-arm value not in abstract | As above | PMID 34798060 |
| Lau 2021, arm 3 | ~100 | Subcutaneous | Cagrilintide 1.2 mg once weekly | Same | Within 6.0%–10.8% range; per-arm value not in abstract | As above | PMID 34798060 |
| Lau 2021, arm 4 | ~100 | Subcutaneous | Cagrilintide 2.4 mg once weekly | Same | Within 6.0%–10.8% range; per-arm value not in abstract | As above | PMID 34798060 |
| Lau 2021, arm 5 | ~100 | Subcutaneous | Cagrilintide 4.5 mg once weekly (escalation up to 6 wk) | Same | Weight −10.8% vs −3.0% placebo; vs −9.0% liraglutide 3.0 mg daily (p=0.03) | As above; permanent stopping 10% overall (similar across groups), 4% for adverse events | PMID 34798060 |
Limitations: sponsor-funded; masked to active vs placebo but not between active doses; per-arm results and dropout by arm not in abstract.
R2 Human: Phase 1b, cagrilintide added to semaglutide (Enebo 2021)
Funded by Novo Nordisk. 95 otherwise-healthy adults with BMI 27–39.9, single US centre. NCT03600480. Background semaglutide 2.4 mg once weekly in all groups.
| Study | People | Route | Dose used | Follow-up | Reported | Side effects / dropouts | Citation |
|---|---|---|---|---|---|---|---|
| Enebo 2021 | 12 per cohort (11 at top) | Subcutaneous | Cagrilintide 1.2 mg weekly + semaglutide 2.4 mg | 20 wk (16 wk escalation + 4 wk) + 5 wk follow-up | Weight −15.7% vs −9.8% pooled placebo + semaglutide | 97% of all cagrilintide groups vs 96% placebo had any adverse event; 37% of events GI | PMID 33894838 |
| Enebo 2021 | 12 | Subcutaneous | Cagrilintide 2.4 mg weekly + semaglutide 2.4 mg | Same | Weight −17.1% vs −9.8% | As above | PMID 33894838 |
| Enebo 2021 | 11 | Subcutaneous | Cagrilintide 4.5 mg weekly + semaglutide 2.4 mg | Same | Weight −15.4% vs −8.0% matched placebo | As above | PMID 33894838 |
| Enebo 2021 | 12 each | Subcutaneous | Cagrilintide 0.16, 0.30 or 0.60 mg weekly + semaglutide 2.4 mg (one row per arm not reported separately in abstract) | Same | Per-arm weight not in abstract | As above | PMID 33894838 |
PK (pharmacokinetics, how the body processes the drug; same study): cagrilintide half-life (time for blood levels to drop by half) 159–195 h; median tmax (time to reach peak blood level) 24–72 h; did not change semaglutide exposure. Limitations: small, short, mostly a safety study.
R3 Human: Thorough QT study (Gabe 2024)
| Study | People | Route | Dose used | Follow-up | Reported | Side effects / dropouts | Citation |
|---|---|---|---|---|---|---|---|
| Gabe 2024, NCT05804162 | 105 healthy (53 cagrilintide, 52 placebo) | Subcutaneous | Cagrilintide escalated to 4.5 mg once weekly | QTcF (heart-rhythm interval corrected for heart rate) at 12, 24, 48, 72 h after last dose | No clinically relevant QTcF prolongation (upper 90% CI < 10 ms at all times) | Not in abstract | PMID 39279639 |
Sponsor-run (Novo Nordisk authors).
R4, R6 Human: Phase 3 trials with a cagrilintide-alone group
| Study | People | Route | Dose used | Follow-up | Reported | Side effects / dropouts | Citation |
|---|---|---|---|---|---|---|---|
| REDEFINE 1 (Garvey 2025), obesity without diabetes | 302 on cagrilintide alone | Subcutaneous | Cagrilintide 2.4 mg once weekly | 68 wk | Unknown Result for this group not in abstract | Not in abstract | PMID 40544433 |
| REIMAGINE 2 (Buse 2026), type 2 diabetes | 152 on cagrilintide alone | Subcutaneous | Cagrilintide 2.4 mg once weekly | 68 wk | Unknown HbA1c/weight for this group not in abstract | Any adverse event 82.2% (125/152) vs 70.5% placebo | PMID 42251859 |
R5 Human: Phase 2 in type 2 diabetes (Frias 2023)
Funded by Novo Nordisk. 92 adults with type 2 diabetes on metformin (± an SGLT2 inhibitor, a class of blood-sugar-lowering pill), BMI 27+, 17 US sites. NCT04982575.
| Study | People | Route | Dose used | Follow-up | Reported | Side effects / dropouts | Citation |
|---|---|---|---|---|---|---|---|
| Frias 2023, cagrilintide arm | 30 | Subcutaneous | Cagrilintide escalated to 2.4 mg once weekly | 32 wk | HbA1c −0.9 points; weight −8.1% | Any adverse event 80% (24/30); mostly mild/moderate GI; no level 2–3 hypoglycaemia (clinically significant or severe low blood sugar) | PMID 37364590 |
R7–R10 Regulatory (as of Oct 24, 2026)
- R7 FDA, FDA's concerns with unapproved GLP-1 drugs used for weight loss (content current as of Oct 1, 2026): "Retatrutide and cagrilintide cannot be used in compounding under federal law. Additionally, these are not components of FDA-approved drugs and have not been found safe and effective for any condition." Checked directly on fda.gov, Oct 24, 2026.
- R8 FDA letter to the Federation of State Medical Boards on compounded cagrilintide, Jun 2, 2025 (PDF hosted by FSMB): cagrilintide has no USP/NF monograph, is not a component of an approved drug and is not on the 503A or 503B bulks lists. UNVERIFIED Read via an FSMB-hosted copy, not on fda.gov.
- R9 FDA warning letters, checked on fda.gov Oct 24, 2026: Prime Sciences, Mar 31, 2026 ("Cagrilintide" sold as "laboratory research purposes only"); Xcel Research LLC, Dec 10, 2024 ("CAGRILINTIDE" and "CagriLean" (cagrilintide and semaglutide) labeled "FOR RESEARCH USE ONLY").
- R10 FDA dosing-error alert for compounded semaglutide: see R9 on our semaglutide page.
- EMA (EU), PMDA (Japan), NMPA (China): UNVERIFIED not checked directly. WADA 2026 Prohibited List checked R11.
Full reference list (all verified on PubMed, Oct 24, 2026)
- Lau DCW, et al. Lancet. 2021;398(10317):2160-2172. doi:10.1016/S0140-6736(21)01751-7. PMID 34798060
- Enebo LB, et al. Lancet. 2021;397(10286):1736-1748. doi:10.1016/S0140-6736(21)00845-X. PMID 33894838
- Gabe MBN, et al. Diabetes Obes Metab. 2024;26(12):5805-5811. doi:10.1111/dom.15951. PMID 39279639
- Garvey WT, et al. N Engl J Med. 2025;393(7):635-647. doi:10.1056/NEJMoa2502081. PMID 40544433
- Frias JP, et al. Lancet. 2023;402(10403):720-730. doi:10.1016/S0140-6736(23)01163-7. PMID 37364590
- Buse JB, et al. Lancet Diabetes Endocrinol. 2026;14(8):662-677. doi:10.1016/S2213-8587(26)00125-7. PMID 42251859
- FDA. FDA's concerns with unapproved GLP-1 drugs used for weight loss (content current as of Oct 1, 2026). https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
- FDA letter to FSMB on compounded cagrilintide, Jun 2, 2025. https://www.fsmb.org/siteassets/communications/fdaCagrilintide.pdf
- FDA warning letters: Prime Sciences (721805, Mar 31, 2026); Xcel Research LLC (694608, Dec 10, 2024). Links in Study details.
- See semaglutide page, R9 (FDA dosing-error alert, content current as of Jul 26, 2024). /library/semaglutide/
- WADA. World Anti-Doping Code International Standard: Prohibited List 2026 (in force Jan 1, 2026). https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf (text read Oct 24, 2026)
Disclaimer
This page is for education and harm reduction. It is not medical advice and not a recommendation to use cagrilintide. Please talk to a clinician you trust before making medical decisions, seek care right away for severe stomach pain or repeated vomiting, and report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).