Cagrilintide / CagriSema

Not FDA-approved on its own or as the CagriSema combination — but real, large, peer-reviewed Phase 3 data exists for both, an NDA is already filed, and an FDA decision could land at any time.

What it is

Cagrilintide is a long-acting amylin receptor agonist from Novo Nordisk. "CagriSema" is the fixed-dose combination of cagrilintide (2.4mg) and semaglutide (2.4mg) in a single injection, positioned as a follow-on to Wegovy with an added appetite-signaling mechanism.

The trial evidence

REDEFINE-1, the peer-reviewed Phase 3 trial in adults with obesity or overweight without diabetes (Davies et al., N Engl J Med 2025, DOI 10.1056/NEJMoa2502081), enrolled roughly 3,400 participants over 68 weeks: CagriSema produced a mean −20.4% body-weight change versus −3.0% on placebo, with about 60% of participants reaching at least 20% weight loss. REDEFINE-2, in adults with type 2 diabetes (Davies, Bajaj, Broholm, Eliasen, Garvey, le Roux, Lingvay, Lyndgaard, Rosenstock, Pedersen, N Engl J Med 2025;393:648-659, DOI 10.1056/NEJMoa2502082, PMID 40544432), reported −13.7% versus −3.4% on placebo. Cagrilintide alone, at 2.4mg, also showed independently meaningful weight loss within the same program — smaller than the combination, but a real result for an amylin analog used on its own.

Regulatory status

Novo Nordisk filed an NDA for CagriSema in December 2025; an FDA decision was still pending as this page was last reviewed, and should be checked again before relying on this page for current approval status.

What's not yet resolved

Industry reporting has described a head-to-head trial in which CagriSema underperformed tirzepatide (Zepbound) on weight loss — a real and notable claim for anyone comparing the two, but one we've only been able to confirm through secondary industry coverage rather than a primary trial-registry entry or peer-reviewed paper, and it should be read with that caveat until a primary source is available.