Novo Nordisk's weekly shot that pairs the amylin analog cagrilintide with semaglutide. Under FDA review for obesity, not approved.
Also called cagrilintide-semaglutide, cagrilintide and semaglutide, Cagri-Sema, CagriSema 2.4 mg/2.4 mg, REDEFINE trials
When CagriSema's status or evidence changes, it's in the next morning's email.
CagriSema is two drugs in one weekly injection: cagrilintide 2.4 mg, a long-acting copy of the pancreas hormone amylin, and semaglutide 2.4 mg, the GLP-1 drug sold as Wegovy. Each one cuts appetite through a different set of receptors in the brain, so Novo Nordisk combined them to get more weight loss than semaglutide gives alone. It is given from a dual-chamber pen.
In REDEFINE 1, 3,417 adults without diabetes were followed for 68 weeks. Counting everyone randomized, weight fell 20.4% on CagriSema, 14.9% on semaglutide alone, 11.5% on cagrilintide alone and 3.0% on placebo. In people with type 2 diabetes the loss was smaller: 13.7% versus 3.4% on placebo in REDEFINE 2. Head to head, it beat semaglutide in a Japanese and Taiwanese trial (18.4% vs 11.9%) but failed to match tirzepatide 15 mg in REDEFINE 4 (23.0% vs 25.5%).
CagriSema is not approved anywhere as of October 2026. Novo Nordisk announced on December 18, 2025 that it had filed it with the FDA and said the review would take place in 2026; analysts expect a decision in the fourth quarter. FDA's list of 2026 novel approvals, current to October 20, 2026, did not include it. The REDEFINE 3 heart outcomes trial in 7,076 people is still running.
What it binds to, and what happens inside the body after that, step by step.
Cagrilintide activates amylin and calcitonin receptors, mainly in the brainstem, which makes meals end sooner. Semaglutide activates the GLP-1 receptor, which also cuts appetite and raises insulin after meals. Because the two hormones act through different receptors, their effects on weight add up. In the phase 1b trial, adding cagrilintide did not change semaglutide's blood levels.
Human results and animal results are kept apart below. A result in rats tells you a mechanism is plausible. It does not tell you what happens in a person.
Multiple large phase 3 trials published in NEJM, Lancet and Lancet Diabetes & Endocrinology show CagriSema lowers weight and blood sugar more than placebo and more than semaglutide alone. It did not match tirzepatide 15 mg in the one head-to-head trial. There are no heart attack, stroke or death outcome data yet, and the drug is not approved.
3,417 adults with obesity or overweight, no diabetes, 68 weeks
Weight fell 20.4% on CagriSema vs 3.0% on placebo (treatment-policy); the semaglutide-alone arm lost 14.9% and cagrilintide alone 11.5%. GI side effects hit 79.6% vs 39.9%.
Read the study1,206 adults with type 2 diabetes and BMI 27 or higher, 68 weeks
Weight fell 13.7% vs 3.4% on placebo; 73.5% reached HbA1c of 6.5% or less vs 15.9%.
Read the study331 East Asian adults with overweight or obesity, with or without type 2 diabetes, 68 weeks
Weight fell 18.4% on CagriSema vs 11.9% on semaglutide 2.4 mg alone (trial product estimand); GI side effects were 53% vs 51%.
Read the study2,713 adults with type 2 diabetes on metformin, with or without an SGLT2 inhibitor, 68 weeks
HbA1c fell 1.91 points on CagriSema 2.4 mg/2.4 mg vs 1.75 points on semaglutide 2.4 mg alone, a small but significant difference.
Read the study809 adults with obesity, open-label, 84 weeks
Weight fell 23.0% on CagriSema vs 25.5% on tirzepatide 15 mg, and the trial missed its non-inferiority goal.
Read the study92 adults with type 2 diabetes and BMI 27 or higher, 32 weeks
Weight fell 15.6% on CagriSema vs 5.1% on semaglutide and 8.1% on cagrilintide; HbA1c drop was not significantly larger than semaglutide's.
Read the study274 adults with type 2 diabetes on basal insulin, 40 weeks
HbA1c fell 2.33 points on 2.4 mg/2.4 mg vs 0.66 on placebo, with 10% to 12% weight loss and no severe low blood sugar.
Read the studyNo preclinical studies are listed as key studies here. The human data above carries the evidence.
When a new CagriSema study in people is published, the daily email covers it.
These are questions the published research has not answered.
No product containing CagriSema is approved as a medicine by the FDA.
Novo Nordisk announced the New Drug Application for weight management on December 18, 2025 and said FDA review would take place in 2026 (company press release); news reports expect a decision in the fourth quarter of 2026. No approval appears on FDA's 2026 novel approvals list, current to October 20, 2026. We found no public confirmation of an EMA filing. REDEFINE 3, the cardiovascular outcomes trial, is due to finish in 2027. WADA: CagriSema is not named on the Prohibited List, but its cagrilintide component has no approval anywhere, so it falls under S0 (non-approved substances), prohibited at all times. Semaglutide alone is allowed and monitored. This is our reading of the S0 rule, not a WADA ruling on CagriSema by name.
When the FDA or WADA changes CagriSema's status, it's in the next morning's email.
How much of CagriSema is left after a single dose
Simple first-order model from the published half-life. Real clearance varies with dose, route, kidney and liver function and formulation. This is not a dosing schedule.
This table records the doses that trials and approved labels used, with the source for each row. It is a record of research, not a recommendation, and it is open to free members.
Which symptoms are expected and which mean stop and get help: side effects and red flags.
Tap a claim to see what the studies found.
It contains the same semaglutide dose as Wegovy plus a second drug, cagrilintide. In REDEFINE 1 the combination gave 20.4% weight loss vs 14.9% for semaglutide alone, and REDEFINE 5 showed 18.4% vs 11.9% in a direct comparison.
In REDEFINE 4, 809 adults, CagriSema gave 23.0% vs 25.5% for tirzepatide 15 mg over 84 weeks and missed its non-inferiority goal.
Novo aimed for 25% but REDEFINE 1 averaged 22.7% in people who stayed on treatment and 20.4% counting everyone. About 40% of adherent users reached 25% or more.
The trials used Novo Nordisk's product at matched doses. Home-mixed vials have never been studied, research chemicals have no verified identity or purity, and FDA says cagrilintide cannot be compounded.
In REDEFINE 5, GI side effects were 53% on CagriSema and 51% on semaglutide. But fewer people reached the top dose on CagriSema in REDEFINE 1 (57.3% vs 70.2%).
Not supplied as a powder. Trial product is a ready-to-use solution in a dual-chamber pen; no approved storage label exists yet.
Not applicable. No public label or stability data.
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