CagriSema

Think of it as a heavily tested prototype car that has aced its crash tests and lap times but has not yet been issued a number plate. The engineering data is real and impressive, but you still cannot legally drive it on the road. The 'CagriSema' kits sold online today are knock-off parts assembled in someone's garage, not the tested vehicle.

Dual GLP-1/amylin appetite suppression. Semaglutide agonises the GLP-1 receptor to enhance satiety, slow gastric emptying and improve glycaemic control. Cagrilintide is a long-acting amylin analogue that agonises amylin and calcitonin receptors to promote satiety and reduce food intake via brainstem (area postrema) and hypothalamic circuits, with a proposed role in restoring leptin sensitivity. The two pathways are complementary, producing greater appetite reduction and weight loss than either alone. Administered by subcutaneous injection once weekly.

Research contexts. Not proven uses, and not recommendations.

Strong and direct for a peptide combination at this stage. The Phase 3 REDEFINE programme enrolled thousands of participants. REDEFINE 1 (n=3,417, without diabetes; published in the New England Journal of Medicine, 2025) showed ~22.7% mean weight loss on the trial-product estimand (~20.4% treatment-policy) versus ~3% placebo over 68 weeks, with both individual drugs as comparator arms. REDEFINE 2 (n=1,206, with type 2 diabetes) showed ~15.7% weight loss versus ~3.1% placebo. This is genuine peer-reviewed human RCT evidence, far beyond animal or in-vitro data backing most grey-market peptides. Long-term and cardiovascular outcome data are still maturing, and no regulator had approved it as of mid-2026.

• !Investigational and unapproved: as of mid-2026 CagriSema is not licensed by the MHRA, FDA or any other regulator and cannot be legally prescribed or sold as a medicine.
• !Grey-market counterfeits: products sold as 'CagriSema' or 'cagri + sema' by research-chemical vendors are unlicensed, unregulated, and of unknown identity, purity, dose and sterility. They are not the trialled product.
• !Gastrointestinal side effects (nausea, vomiting, diarrhoea, constipation) are common, consistent with the GLP-1/amylin class.
• !Headline efficacy fell short of Novo Nordisk's internal expectations in REDEFINE 1, partly due to flexible dose escalation in which many participants did not reach the top dose.
• !Long-term safety and cardiovascular outcome data are not yet available.
• !As with other GLP-1 agents, weight regain is expected after stopping, and loss of lean/muscle mass plus class-wide cautions apply.

Investigational and not licensed in the UK. As of mid-2026 CagriSema holds no MHRA marketing authorisation and is not approved anywhere in the world. Novo Nordisk filed with the FDA in December 2025, with a first decision expected in late 2026. No UK/MHRA submission has been publicly confirmed. It cannot lawfully be prescribed or sold as a medicine in the UK. Any product marketed as 'CagriSema' by research-chemical suppliers is an unlicensed substance, not the trialled medicine, and selling or supplying it for human use would breach the Human Medicines Regulations 2012. A future NHS route would require NICE appraisal after any MHRA licence is granted.

• NCT05567796· Phase 3· Active, not recruiting (primary results reported, NEJM 2025)

  REDEFINE 1 - CagriSema in overweight/obesity without type 2 diabetes

  n=3,417; 68 weeks; ~22.7% mean weight reduction (trial-product estimand) vs ~3% placebo; included cagrilintide and semaglutide monotherapy arms.

• NCT05394519· Phase 3· Completed (reported 2025)

  REDEFINE 2 - CagriSema in overweight/obesity with type 2 diabetes

  n=1,206; ~15.7% weight loss vs ~3.1% placebo at 68 weeks.

1. 01
   Cagrilintide-Semaglutide in Adults with Overweight or Obesity (REDEFINE 1), New England Journal of Medicine (2025)

   Pivotal Phase 3 RCT, n=3,417; ~22.7% mean weight reduction over 68 weeks vs ~3% placebo, with cagrilintide and semaglutide monotherapy comparator arms.

2. 02
   Once-weekly cagrilintide for weight management in people with overweight and obesity: a dose-finding phase 2 trial — Lau DCW, Erichsen L, Francisco AM, et al., The Lancet (vol 398, pp 2160-2172) (2021)

   Earlier human evidence for the amylin-analogue component cagrilintide as a standalone weight-loss agent, supporting the combination rationale.

3. 03
   Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management, Novo Nordisk company announcement / PR Newswire (2025)

   Confirms investigational status and US FDA submission (December 2025); no approval in any jurisdiction at time of filing.

4. 04
   CagriSema demonstrates superior weight loss in adults with obesity or overweight and type 2 diabetes in the REDEFINE 2 trial, Novo Nordisk company announcement (2025)

   Phase 3 REDEFINE 2 headline results, n=1,206; ~15.7% weight loss vs ~3.1% placebo at 68 weeks.