Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor

Clinical Trial22 Apr 2026Phase 3

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor

Novo Nordisk A/S

Phase 3 head-to-head trial compares CagriSema (dual cagrilintide and semaglutide) 2.4/2.4 mg against tirzepatide 15 mg weekly in adults with type 2 diabetes inadequately controlled on metformin with or without SGLT2 inhibitors. The randomized trial enrolled 1,000 participants with primary endpoints of HbA1c and weight change, completing in March 2026. This represents Novo Nordisk's direct challenge to Eli Lilly's tirzepatide dominance with a novel dual-agonist combination targeting both GLP-1 and amylin receptors. The head-to-head design positions CagriSema for potential differentiation in the competitive dual-agonist space.

Strategic Signal

Novo Nordisk directly targets tirzepatide's market position with the first head-to-head dual-agonist comparison, setting up a critical evidence battle for second-line diabetes therapy after metformin failure. The trial's completion timing aligns with CagriSema's anticipated regulatory filing, giving Novo real-world superiority claims against the established tirzepatide standard. This head-to-head strategy mirrors successful GLP-1 launches where direct comparisons drove formulary positioning and prescriber confidence in crowded therapeutic classes.

GLP-1Type 2 diabetesDrug comparisonsNovo Nordisk Eli Lilly

Original Abstract

This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years. | Condition(s): Type 2 Diabetes | Primary endpoint(s): Change in glycated haemoglobin (HbA1c); Relative change in body weight | Enrollment: 1,024 (actual) | Phase: Phase 3 | Sponsor: Novo Nordisk A/S | Expected completion: 2026-03-04 | Status: Completed | Last update: 2026-04-22

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