CagriSema dosage and evidence

What is CagriSema?

How does CagriSema work?

It works on two fullness signals at once. The amylin part helps you feel full. The GLP-1 part cuts appetite, helps release insulin and slows how fast food leaves the stomach. The two effects add up.

What have studies in people found about CagriSema?

CagriSema has large final-stage trial data for a drug that is not yet approved. More than 4,900 people took part in three large trials, plus 92 in a mid-stage trial. What it still lacks is any data on heart attacks, strokes or deaths. It also lacks a published head-to-head against its main rival.

• The biggest trial: 3,417 adults with extra weight and no diabetes got the combination, semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone, or a dummy shot. On the combination they lost 20.4% at 68 weeks, against 3.0% on the dummy, a gap of 17.3 points. Counted as if everyone had stayed on the drug as planned, the loss was 22.7%. Stomach and gut side effects hit 79.6% against 39.9%.
• Type 2 diabetes: 1,206 adults lost 13.7% at 68 weeks, against 3.4% on a dummy shot. 73.5% got their three-month average blood sugar to 6.5% or lower.
• Against semaglutide alone: 331 people in Japan and Taiwan got the combination or semaglutide 2.4 mg by itself, not a dummy. They lost 18.4% against 11.9% at 68 weeks, a gap of 6.5 points. Side effects hit 87% against 84%, and stomach and gut side effects 53% against 51%.
• A mid-stage trial: 92 adults with type 2 diabetes over 32 weeks lost 15.6% on the combination, 5.1% on semaglutide alone and 8.1% on cagrilintide alone.
• The head-to-head against tirzepatide 15 mg (NCT06131437) had 809 people with obesity. It is listed as finished on 8 December 2025. No results were posted and no paper had appeared when we checked.
• The heart outcome trial (NCT05669755) has 7,101 people who already have heart disease. It is still running, is no longer taking new people, and is due in September 2027.

What this does not tell you: There is no outcome evidence at all: no heart attacks, strokes, kidney results or deaths. The heart trial built to supply it will not report before 2027. The only published comparison with another drug is against semaglutide, which the same company sells. The comparison readers actually want, against tirzepatide, finished in December 2025 and has not appeared. The gap between the two ways of counting the main trial, 20.4% and 22.7%, is not a rounding difference. It shows that many people did not stay on the top dose. The bigger number describes what happens if they do. Nothing is known past 68 weeks, and the drug is not approved anywhere.

The state of the research

The evidence, in charts

The studies we cite

• Study in people2025
  Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1)

  This is about as strong as obesity evidence gets. 3,417 adults took the combination or a dummy injection for about 16 months. On the drug they lost roughly a fifth of their body weight. On the dummy they lost about 3 percent. In plain terms, someone starting at 220 pounds ended up around 45 pounds lighter. A second way of counting, which asks what happens to people who stay on treatment, puts the loss a little higher still.

  3,417 adults: 20.4% weight loss at 68 weeks versus 3.0% with placebo (treatment-policy estimand); 22.7% by trial-product estimand.

  PMID 40544433 New England Journal of Medicine
• Study in people2025
  Cagrilintide-semaglutide in adults with overweight or obesity and type 2 diabetes (REDEFINE 2)

  The same combination worked in people who also had type 2 diabetes, and it worked less well. 1,206 patients took it or a dummy for about 16 months. They lost close to 14 percent of their weight, against roughly 3 percent on the dummy. Weight drugs reliably do less in diabetes than outside it, and this is that pattern again. Less than a fifth is still a great deal of weight.

  1,206 patients with type 2 diabetes: 13.7% weight loss at 68 weeks versus 3.4% with placebo.

  PMID 40544432 New England Journal of Medicine
• Study in people2025
  Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management

  This is a company announcement, not a study. Novo Nordisk filed for approval in December 2025 on the strength of its two large trials. It reports that more than nine in ten people on the drug lost at least 5 percent of their body weight. Filing is not approval. Treat the figure as the company's own summary of results published elsewhere.

  NDA submitted December 18, 2025 based on REDEFINE 1 and 2; 91.9% of CagriSema participants lost at least 5%.

  Source Novo Nordisk press release
• Study in people2026
  Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5): a multicentre, randomised, active-controlled, phase 3a trial

  CagriSema beat semaglutide alone, by a useful but not transforming margin. 331 people in Japan and Taiwan were split by chance between the combination and semaglutide by itself, so the comparison was against a working drug rather than a dummy. After 68 weeks the combination group had lost 18.4% of their body weight and the semaglutide group 11.9%. Stomach and bowel side effects ran about the same on both. This is the only published trial pitting CagriSema against an active drug.

  331 participants randomized against semaglutide 2.4 mg rather than placebo: -18.4% versus -11.9% at 68 weeks, an estimated treatment difference of 6.5 percentage points, with similar rates of gastrointestinal adverse events in both arms.

  PMID 42009015 The Lancet Diabetes & Endocrinology
• Study in people2025
  Efficacy and Safety of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly Compared to Tirzepatide 15 mg s.c. Once-weekly in Participants With Obesity

  The comparison everybody wants, CagriSema against tirzepatide, has finished and published nothing. 809 people with obesity took part, and the registry records the trial as completed on 8 December 2025. No results have been posted there and no paper has appeared. A finished trial that reports nothing is itself a finding. Until it publishes, nobody can honestly say which of these two drugs takes off more weight.

  The head-to-head against tirzepatide: 809 participants, listed as completed with primary completion December 8, 2025. No results posted and no publication indexed at review, so no head-to-head figure for these two drugs can currently be cited.

  NCT06131437 ClinicalTrials.gov NCT06131437 (REDEFINE 4), Novo Nordisk
• Study in people2026
  The Cardiovascular Safety and Efficacy of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) Once-weekly in Participants With Established Cardiovascular Disease

  Nothing is known about whether CagriSema prevents heart attacks or strokes. This is the only trial built to answer that, and it has not finished. 7,101 people who already have heart disease are enrolled, and the first results are listed for September 2027. It is no longer recruiting. Every published CagriSema number so far is about weight and blood sugar, not about the events people take these drugs to avoid.

  The only CagriSema trial with hard clinical endpoints: 7,101 participants with established cardiovascular disease, active and not recruiting, primary completion listed for September 2027. Until it reports there is no outcome evidence for this combination.

  NCT05669755 ClinicalTrials.gov NCT05669755 (REDEFINE 3), Novo Nordisk