Cagrilintide vs Semaglutide
Amylin against GLP-1, from the same company: one is the approved benchmark for weight loss, the other a different satiety hormone still proving it works alone.
Short answer
Semaglutide has FDA approval and cagrilintide does not, which is the main thing separating them. Semaglutide fits a reader who wants an FDA-approved product, while cagrilintide is marketed for weight loss. On the evidence, cagrilintide has human clinical data and semaglutide has approval-level evidence.
Cagrilintide
A long-acting amylin analog with real Phase 2 monotherapy weight-loss data; its main clinical role is as the amylin half of CagriSema, and on its own it remains investigational.
Full Cagrilintide evidence reviewSemaglutide
Wegovy / Ozempic
~15% mean weight loss in STEP 1; the benchmark that opened modern obesity medicine.
Full Semaglutide evidence reviewCagrilintide vs Semaglutide: head to head
- FDA status / approved use
Cagrilintide
Investigational and not approved on its own; FDA decision on the CagriSema combination expected fourth quarter 2026Semaglutide
FDA-approved- Marketed for
Cagrilintide
Weight lossSemaglutide
Weight loss, type-2 diabetes- Outcome areas
Cagrilintide
Weight loss / appetiteSemaglutide
Weight loss / appetite; Blood sugar / insulin sensitivity- Evidence grade
Cagrilintide
Clinical dataSemaglutide
FDA-approved- How it works
Cagrilintide
Long-acting amylin analog; slows stomach emptying and signals fullness through the hindbrainSemaglutide
GLP-1 receptor agonist- Route and dosing
Cagrilintide
Subcutaneous injection, once weeklySemaglutide
Subcutaneous, once weekly (Wegovy label); maintenance 2.4 mg (recommended) or 1.7 mg once weekly- Headline human result
Cagrilintide
6.0% to 10.8% weight loss vs 3.0% on placebo over 26 weeks in a 2021 Phase 2 trial of 906 adultsSemaglutide
14.9% mean weight loss vs 2.4% on placebo at 68 weeks (STEP 1, 2.4 mg weekly)- Strongest evidence
Cagrilintide
Phase 2 monotherapy RCT, Lancet 2021Cagrilintide evidence reviewPubMed 34798060Semaglutide
STEP 1, NEJM 2021Semaglutide evidence reviewPubMed 33567185- Key safety signal
Cagrilintide
Nausea-led gastrointestinal side effects that rise with doseSemaglutide
Nausea, vomiting and constipation, mainly when the dose is raised too quickly- How it is obtained
Cagrilintide
Legitimately available only inside clinical trials; vials sold online are gray-market research chemicalsSemaglutide
Prescription. Manufacturer self-pay for Wegovy (injection pen) runs $349–$399 per fill, against a $1,349 list priceWegovy cost breakdown
| Cagrilintide | Semaglutide | |
|---|---|---|
| FDA status / approved use | Investigational and not approved on its own; FDA decision on the CagriSema combination expected fourth quarter 2026 | FDA-approved |
| Marketed for | Weight loss | Weight loss, type-2 diabetes |
| Outcome areas | Weight loss / appetite | Weight loss / appetite; Blood sugar / insulin sensitivity |
| Evidence grade | Clinical data | FDA-approved |
| How it works | Long-acting amylin analog; slows stomach emptying and signals fullness through the hindbrain | GLP-1 receptor agonist |
| Route and dosing | Subcutaneous injection, once weekly | Subcutaneous, once weekly (Wegovy label); maintenance 2.4 mg (recommended) or 1.7 mg once weekly |
| Headline human result | 6.0% to 10.8% weight loss vs 3.0% on placebo over 26 weeks in a 2021 Phase 2 trial of 906 adults | 14.9% mean weight loss vs 2.4% on placebo at 68 weeks (STEP 1, 2.4 mg weekly) |
| Strongest evidence | Phase 2 monotherapy RCT, Lancet 2021Cagrilintide evidence reviewPubMed 34798060 | STEP 1, NEJM 2021Semaglutide evidence reviewPubMed 33567185 |
| Key safety signal | Nausea-led gastrointestinal side effects that rise with dose | Nausea, vomiting and constipation, mainly when the dose is raised too quickly |
| How it is obtained | Legitimately available only inside clinical trials; vials sold online are gray-market research chemicals | Prescription. Manufacturer self-pay for Wegovy (injection pen) runs $349–$399 per fill, against a $1,349 list priceWegovy cost breakdown |
marks a row where the two differ. “Not established” marks a cell the available evidence does not answer. Evidence grades come from our evidence matrix, which grades each molecule on the human data for the use it is marketed for.
- FDA-approved:
- Approved by the FDA for a defined indication, on the strength of pivotal human trials.
- Clinical data:
- Tested in humans — but investigational, discontinued, or proven only on a surrogate marker (not the marketed outcome).
Our verdict
Semaglutide is approved and cagrilintide is not, which settles the practical question immediately. The interesting one is mechanistic: amylin is not a GLP-1. It signals satiation through largely separate machinery, slowing gastric emptying and acting through the hindbrain, which is precisely why Novo Nordisk pairs the two in CagriSema rather than choosing between them. On effect size the comparison is lopsided and cross-trial: semaglutide’s STEP 1 produced about 15% mean weight loss, while cagrilintide’s record is a 26-week phase 2 dose-finding trial. One caution worth stating plainly — a different mechanism is not a gentler one. Cagrilintide carries the gut-hormone class’s nausea-led tolerability profile, so it is not the softer option its separate pathway might imply.
Cagrilintide fits if
You are following the amylin pathway itself and want the standalone monotherapy data, rather than the combination it is most likely to reach patients inside.
Semaglutide fits if
You want a weight-loss medicine you can actually be prescribed, with a pivotal trial program and a cardiovascular outcomes trial behind it.
Cagrilintide vs Semaglutide: common questions
- Is semaglutide FDA-approved but cagrilintide not?
- Yes. Semaglutide is FDA-approved. Cagrilintide is investigational and not approved on its own; FDA decision on the CagriSema combination expected fourth quarter 2026.
- Which has stronger human evidence, cagrilintide or semaglutide?
- Semaglutide. It has approval-level evidence (key source: STEP 1, NEJM 2021), while cagrilintide has human clinical data (key source: Phase 2 monotherapy RCT, Lancet 2021).
- What are the main safety concerns with cagrilintide and semaglutide?
- For cagrilintide, watch for nausea-led gastrointestinal side effects that rise with dose. For semaglutide, watch for nausea, vomiting and constipation, mainly when the dose is raised too quickly.
Key studies behind each
Cagrilintide
- Hay DL, Chen S, Lutz TA, et al. (2015). Amylin: Pharmacology, Physiology, and Clinical Potential. Pharmacol Rev. PubMed 26071095
- Boyle CN, Lutz TA, Le Foll C. (2018). Amylin - Its role in the homeostatic and hedonic control of eating and recent developments of amylin analogs to treat obesity. Mol Metab. PubMed 29203236
- Lau DCW, Erichsen L, Francisco AM, et al. (2021). 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. PubMed 34798060
- Enebo LB, Berthelsen KK, Kankam M, et al. (2021). 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. PubMed 33894838
Semaglutide
- Wilding JPH, Batterham RL, Calanna S, et al. (2021). Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1). N Engl J Med. PubMed 33567185
- Rubino D, Abrahamsson N, Davies M, et al. (2021). Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance (STEP 4). JAMA. PubMed 33755728
- Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. (2023). Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT). N Engl J Med. PubMed 37952131
- Jastreboff AM, Aronne LJ, Ahmad NN, et al. (2022). Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1). N Engl J Med. PubMed 35658024
The full evidence reviews
- Cagrilintide: what it is, results, and when it could be approved
The amylin analog behind CagriSema, on its own terms: a long-acting amylin analog, not a GLP-1, that produced dose-dependent weight loss as a standalone weekly injection in Phase 2. The evidence, and where it sits.
Updated October 2026
- What the semaglutide weight-loss trials actually showed
STEP 1, STEP 4, and SELECT — the efficacy, the rebound, and the cardiovascular signal, read straight from the primary literature.
Updated August 2026