Efficacy and Safety of Cagrilintide s.c. in Combination With Semaglutide s.c. (CagriSema s.c.) Once Weekly for Weight Management and Long-term Weight Maintenance in Participants With Obesity

Clinical Trial12 Dec 2025Phase 3High impact● 8/10i

Efficacy and Safety of Cagrilintide s.c. in Combination With Semaglutide s.c. (CagriSema s.c.) Once Weekly for Weight Management and Long-term Weight Maintenance in Participants With Obesity

Novo Nordisk A/S

Novo Nordisk is testing CagriSema (cagrilintide plus semaglutide combination) against placebo in 609 people with obesity across a 3-year phase 3 trial for weight management and long-term maintenance. The study includes a main phase followed by an extension where all participants receive active treatment at different doses. This represents Novo's dual-hormone strategy to extend beyond single GLP-1 therapy, competing directly with Eli Lilly's tirzepatide franchise in obesity. The 3-year duration targets the critical question of sustained weight loss that regulators and payers prioritize.

Strategic Signal

Novo is advancing its dual amylin/GLP-1 approach to challenge Eli Lilly's dual GIP/GLP-1 dominance, with CagriSema positioned as the next-generation obesity treatment beyond Wegovy. The 3-year design directly addresses FDA and EMA emphasis on durability data, potentially supporting premium positioning versus existing GLP-1 monotherapy. If superior to tirzepatide weight loss benchmarks, this could shift the competitive narrative from Lilly's current dual-hormone leadership back to Novo's innovation pipeline.

Weight lossGLP-1Novo Nordisk Eli Lilly

Original Abstract

This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. Which dose of CagriSema participants will continue on is decided by chance. If participants get placebo in the main study, participants will get CagriSema in the extension study. Participants will take one injection of study medicine once a week. The study will last for about 3 years and 3 months. | Condition(s): Obesity | Primary endpoint(s): Relative change in body weight | Enrollment: 609 (actual) | Phase: Phase 3 | Sponsor: Novo Nordisk A/S | Expected completion: 2027-03-01 | Status: Active Not Recruiting | Last update: 2025-12-12

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