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Also: cagrilintide + semaglutide · AM833 · NNC0174-0833 · NN9838
Four separate measurements, never averaged. Independent evidence counts only studies with no sponsor attached. Methodology version v2.0-2026-10 · how we grade evidence
Being developed to produce greater weight loss than semaglutide alone in adults with obesity or overweight with comorbidities, and to reduce body weight and HbA1c in adults with obesity and type 2 diabetes. It is not approved anywhere, and Novo Nordisk’s own ADA 2026 material states plainly that CagriSema "is not approved in the United States. Safety and efficacy are not established."
It is under active FDA review: Novo submitted a United States application for weight management in December 2025 on the strength of REDEFINE 1 and REDEFINE 2, and guided to a decision in the fourth quarter of 2026. No PDUFA date has been made public. There is no European submission; Novo states the EU pathway awaits REDEFINE 3, the cardiovascular outcomes trial, expected to read out in the second half of 2027.
One result cuts against the development claim. REDEFINE 4, the head-to-head against tirzepatide, missed its primary endpoint — CagriSema numerically underperformed the comparator and failed non-inferiority. That trial was open-label, and Novo published no p-values, confidence intervals or non-inferiority margin with it.
Semaglutide’s own safety profile is characterised from years of marketed use, which de-risks half the combination; cagrilintide has no marketed history at all, and there is no post-marketing surveillance because the product has never been sold. Cagrilintide is sold online by "research peptide" vendors; those products are not the studied product, are not made to pharmaceutical standards, and none of the data below transfers to them.
At a glance
Semaglutide activates the GLP-1 receptor, reducing appetite and slowing gastric emptying. Cagrilintide is a long-acting analogue of amylin that agonises amylin and calcitonin receptors, acting on a satiation pathway largely distinct from the incretin pathway. Combining them is intended to recruit two separate appetite-control mechanisms at once for additive weight loss. Unusually for this cluster, that intention was tested directly in humans rather than inferred. REDEFINE 1 carried standalone semaglutide and standalone cagrilintide arms alongside the combination and placebo, and the combination outperformed each component: 20.4% versus 14.9% for semaglutide alone, 11.5% for cagrilintide alone and 3.0% for placebo.
Dated determinations, each flagged for whether it is final and whether it covers safety only. A safety review is not an efficacy finding, and most reporting in this category conflates the two.
Novo states that the "regulatory pathway for CagriSema T2D and obesity in EU [is] pending REDEFINE 3" — the cardiovascular outcomes trial, expected to read out in the second half of 2027. The European regulator is waiting for cardiovascular outcome data that the United States application did not require. Date recorded as the Q2 2026 investor materials in which the position was stated.
Novo Nordisk submitted a United States New Drug Application for weight management in December 2025 on the basis of REDEFINE 1 and REDEFINE 2. Novo’s Q2 2026 investor materials list it as "Submitted in the US" with a "US decision on CagriSema submission in obesity expected in Q4 2026," and its announcement of 23 February 2026 says "an FDA decision is anticipated by late 2026." No PDUFA date has ever been made public. Novo’s own ADA 2026 material states: "CagriSema... [is] not approved in the United States. Safety and efficacy are not established." A United States type 2 diabetes submission was expected in late 2027. The occurrence date here is the submission month, since there is no decision to date.
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