Cagrilintide research: studies, doses and safety
An unapproved weekly amylin analogue with weight-loss trials and common stomach symptoms.
Also called: AM833, NNC0174-0833, NN9838, Cagri.
Amylin analogues · Long-acting amylin analogue; amylin and calcitonin receptor agonist.
- Weeks 1-2, phase 2 higher-dose paths: The 1.2 mg, 2.4 mg and 4.5 mg target groups began at 0.6 mg weekly in the phase 2 trial.
- Weeks 3-4, phase 2 higher-dose paths: Those phase 2 groups moved to 1.2 mg weekly after two weeks.
- Weeks 5-6, phase 2 higher-dose paths: The phase 2 groups targeting 2.4 mg or 4.5 mg moved to 2.4 mg weekly.
- Week 7 onward, phase 2 highest-dose path: The phase 2 group targeting 4.5 mg reached that weekly dose after six weeks.
- Week 26: The phase 2 trial estimated 6.0-10.8% average weight loss if treatment was followed versus 3.0% with placebo, with nausea common.
The phase 2 obesity trial used weekly injections for 26 weeks, then six weeks of follow-up without treatment.
27 unique registered studies with cagrilintide-alone or comparator arms; includes ongoing/unreported trials. Reviews and animal studies are not counted.
Key studies
- First human single-dose study: Status: completed. No clinical benefit is established by registration. (source)
- First repeat-dose study: Status: completed. No clinical benefit is established by registration. (source)
- Japanese and White adults: PK: Status: completed. No clinical benefit is established by registration. (source)
- Phase 2: five weekly doses: All five cagrilintide doses reduced weight more than placebo. (source)
- Birth-control pill interaction: Status: completed. No clinical benefit is established by registration. (source)
- Single dose: kidney impairment: A single dose showed no clinically relevant kidney-related exposure change. (source)
Related to Cagrilintide
- CagriSema: An unapproved cagrilintide–semaglutide combination with phase 3 weight-loss and diabetes results.
- Pramlintide: A diabetes medicine that copies a hormone released with insulin; Symlin products are discontinued.
- Semaglutide: A GLP-1 medicine with strong weight, glucose, heart and kidney evidence; dose and formulation matter.
- Tirzepatide: A weekly GIP/GLP-1 injection with strong diabetes and weight-loss evidence and common stomach side effects.
- Retatrutide: An experimental weekly injection with phase 3 weight-loss results.
Sources
- 503B Bulk Drug Substances List, FDA · FDA · 2026
- The Prohibited List, World Anti-Doping Agency · World Anti-Doping Agency · 2026
- Nutritional priorities to support GLP-1 therapy for obesity: a joint Advisory from the American College of Lifestyle Medicine, the American Society for Nutrition, the Obesity Medicine Association, and The Obesity Society., Mozaffarian D et al. · The American journal of clinical nutrition · 2025
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act
- Chest pain, NHS
- European Medicines Agency decision P/0307/2023 of 4 August 2023 on the granting of a product specific waiver for cagrilintide / semaglutide (EMEA-003059-PIP02-23)
- FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, US Food and Drug Administration
- PIP Search Page, MHRA
- SYMLINPEN- pramlintide acetate injection
- Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026
- Understanding your responsibilities when importing, compounding and supplying unapproved peptide products
- Vision loss, NHS
- Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study., Buse JB et al. · The lancet. Diabetes & endocrinology · 2026
- Efficacy and Safety of Cagrilintide and Cagrisema Versus Semaglutide as Anti-Obesity Medications: A Systematic Review, Meta-Analysis and Meta-Regression., Ahmed M et al. · Diabetes, obesity & metabolism · 2026
- Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide., Nielsen MJF et al. · Clinical pharmacokinetics · 2026
Sources checked: 2026-10-18.
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