CagriSema research: studies, doses and safety
An unapproved cagrilintide–semaglutide combination with phase 3 weight-loss and diabetes results.
Also called: Cagrilintide/semaglutide, Cagrilintide-semaglutide, CagriSema 2.4 mg/2.4 mg.
Amylin analogues · Combination of an amylin analogue and a GLP-1 receptor agonist.
- Weeks 1-16: REDEFINE 1 used a 16-week period of gradually increasing weekly doses under trial supervision.
- Weeks 17-68: The trial then continued weekly injections through a 52-week maintenance phase.
- Week 68: REDEFINE 1 found average weight loss of 20.4% versus 3.0% with placebo, with stomach side effects common.
REDEFINE 1 studied weekly cagrilintide plus semaglutide for 68 weeks in adults without diabetes.
33 unique registered combination studies plus one simulated-use pen study. Includes ongoing/unreported records; reviews and secondary analyses are not new trials.
Key studies
- Phase 1b: six combination doses: Early combination testing supported weekly dosing and further trials. (source)
- Combined versus separate injections: Status: completed. No clinical benefit is established by registration. (source)
- Phase 2: combination versus each drug: The combination added weight loss; its HbA1c advantage over semaglutide was not significant. (source)
- MASH trial: exploratory CagriSema arm: This exploratory combination arm did not establish a liver-fibrosis benefit. (source)
- REDEFINE 2: obesity with diabetes: The combination reduced weight and HbA1c in people with type 2 diabetes. (source)
- REDEFINE 1: obesity without diabetes: The combination reduced weight more than placebo; its components also had separate arms. (source)
Related to CagriSema
- Cagrilintide: An unapproved weekly amylin analogue with weight-loss trials and common stomach symptoms.
- 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.
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
- Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026
- Understanding your responsibilities when importing, compounding and supplying unapproved peptide products
- Vision loss, NHS
- Wegovy PI, Novo Nordisk
- Cagrilintide-semaglutide (CagriSema) as an add-on to basal insulin in adults with type 2 diabetes (REIMAGINE 3): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study., Rosenstock J et al. · Lancet (London, England) · 2026
- 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
- CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1., Verma S et al. · Hypertension (Dallas, Tex. : 1979) · 2026
Sources checked: 2026-10-18.
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