Efficacy and Safety of Cagrilintide s.c. 2.4 Milligram (mg) in Combination With Semaglutide Subcutaneous (s.c). 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity

ClinicalTrials30 Mar 2026·Phase 3● 8/10i

Efficacy and Safety of Cagrilintide s.c. 2.4 Milligram (mg) in Combination With Semaglutide Subcutaneous (s.c). 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity

Novo Nordisk A/S

Phase 3 trial testing CagriSema (cagrilintide + semaglutide 2.4mg combination) versus placebo, cagrilintide alone, and semaglutide alone in 3,400 people with overweight or obesity. The 1.5-year main study plus 2-year extension tracks weight loss and maintenance after stopping treatment. Novo Nordisk is advancing its dual-hormone combination therapy against established GLP-1 monotherapy to potentially expand its obesity franchise beyond Wegovy. The extension phase design addresses a key clinical question about weight regain after discontinuation that could influence prescriber confidence and payer coverage decisions.

Strategic signal

Novo's CagriSema combination faces a challenging market access pathway given payers' existing coverage restrictions on Wegovy and Zepbound monotherapies. The four-arm design directly positions CagriSema against both component therapies, creating internal competition with Wegovy while potentially cannibalizing semaglutide sales. The 2-year extension studying weight maintenance post-discontinuation could provide differentiation versus existing obesity therapies if superior durability is demonstrated, but also risks highlighting the chronic treatment requirement that drives payer resistance to obesity medications.

GLP-1Weight lossNovo Nordisk

Original Abstract

This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms. Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years. | Condition(s): Obesity | Primary endpoint(s): CagriSema versus placebo: Relative change in body weight; CagriSema versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction | Enrollment: 3,400 (estimated) | Phase: Phase 3 | Sponsor: Novo Nordisk A/S | Expected completion: 2024-10-30 | Status: Active Not Recruiting | Last update: 2026-03-30

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