Written By: Pharmacally Medical News Desk
Novo Nordisk has taken a major step in obesity drug development by filing a regulatory application with the U.S. Food and Drug Administration (FDA) for CagriSema, a once-weekly injectable therapy designed for chronic weight management. If approved, CagriSema would become the first combination treatment that brings together a GLP-1 receptor agonist and an amylin analogue in a single, once-weekly formulation.
The filing highlights Novo Nordisk’s strategy to move beyond single-pathway incretin therapies and target multiple biological mechanisms involved in appetite control, satiety, and energy intake.
What Is CagriSema?
CagriSema is a fixed-dose combination of two well-studied metabolic hormone pathways:
- Semaglutide, a GLP-1 receptor agonist that reduces appetite, slows gastric emptying, and improves glycaemic control
- Cagrilintide, a long-acting amylin analogue that enhances feelings of fullness and helps regulate post-meal satiety
By combining these two agents, CagriSema is designed to provide complementary and potentially additive effects on weight loss, addressing both hunger signals and meal-related satiety.
The therapy is administered once weekly, aligning with current patient preferences for less frequent dosing and improving long-term treatment adherence.
Clinical Development and Evidence-Based
The NDA for CagriSema is supported by results from the global Phase 3 REDEFINE clinical development program, which evaluated the efficacy and safety of once-weekly CagriSema as an adjunct to lifestyle intervention across adults with obesity or overweight, with and without type 2 diabetes.
REDEFINE 1 was a 68-week, Phase 3, randomized, double-blind, placebo- and active-controlled trial. The study compared once-weekly CagriSema with semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone, or placebo, all on top of a standardized lifestyle intervention. CagriSema demonstrated superior weight reduction versus placebo and both monotherapy comparators, supporting the added clinical benefit of combining GLP-1 and amylin pathways in a single regimen.
REDEFINE 2 was a 68-week, Phase 3, randomized, double-blind, placebo-controlled trial enrolling 1,206 adults with type 2 diabetes and either obesity or overweight. In this population, once-weekly CagriSema showed statistically significant and clinically meaningful reductions in body weight compared with placebo, while maintaining glycemic control consistent with GLP-1–based therapy.
Across both trials, CagriSema showed a safety and tolerability profile consistent with its individual components, with gastrointestinal adverse events being the most commonly reported and generally manageable through dose escalation.
Mike Doustdar, President and CEO, Novo Nordisk, said the FDA submission of CagriSema marks a major milestone for the company’s obesity strategy, highlighting the potential of combining semaglutide with a novel mechanism to advance holistic obesity treatment. He emphasized that the REDEFINE clinical program supports CagriSema’s efficacy, tolerability, and strong treatment completion rates, and noted that, if approved, the therapy could expand treatment options and help address unmet needs in long-term obesity management.
Looking ahead, the FDA is expected to complete its review of the CagriSema application in 2026, marking the next key regulatory milestone for the program. In parallel, Novo Nordisk continues to advance a broad and long-term clinical strategy for CagriSema through the ongoing REDEFINE Phase 3 program. This includes REDEFINE 3, an event-driven cardiovascular outcomes trial designed to assess long-term cardiovascular safety, and REDEFINE 11, a longer-duration Phase 3 study focused on adults with BMI ≥30 kg/m².
References
Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP‑1 and amylin analogues for weight management, 18 December 2025, https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916470
“CagriSema: A Powerful New Weight Loss and Diabetes Combination Therapy Emerges from REDEFINE-2 Trial” 14 June 2025, https://pharmacally.com/cagrisema-a-powerful-new-weight-loss-and-diabetes-combination-therapy-emerges-from-redefine-2-trial/
A Research Study to See How Well CagriSema Helps People with Excess Body Weight Lose Weight (REDEFINE 1), ClinicalTrials.gov ID NCT05567796, https://clinicaltrials.gov/study/NCT05567796