Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both

Clinical Trial9 Jun 2026Phase 3

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both

Novo Nordisk A/S

Phase 3 trial compares CagriSema (cagrilintide + semaglutide combination) 1.0 mg weekly versus tirzepatide 5 mg weekly in 1,023 adults with type 2 diabetes inadequately controlled on metformin, SGLT2 inhibitor, or both. Active comparator design with 68-week duration, completion expected June 2026. This represents Novo Nordisk's direct challenge to Eli Lilly's tirzepatide dominance, testing whether dual amylin/GLP-1 combination can match dual GIP/GLP-1 efficacy in the core type 2 diabetes market. Head-to-head positioning against tirzepatide's lowest approved dose could support differentiated commercial messaging if CagriSema demonstrates superiority.

Strategic Signal

Novo Nordisk is positioning CagriSema as a direct tirzepatide competitor in type 2 diabetes, where tirzepatide has shown superior efficacy versus semaglutide monotherapy. The head-to-head design against tirzepatide's 5 mg dose creates a commercial messaging opportunity if CagriSema achieves superiority, potentially supporting premium pricing versus existing GLP-1s. US endocrinologists have established tirzepatide as the preferred second-line agent after metformin, making this comparison critical for CagriSema's market positioning.

GLP-1Type 2 diabetesDrug comparisonsNovo Nordisk Eli Lilly

Original Abstract

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months. | Condition(s): Diabetes Mellitus, Type 2 | Primary endpoint(s): Change in Glycated Haemoglobin (HbA1c); Relative Change in Body Weight | Enrollment: 1,023 (actual) | Phase: Phase 3 | Sponsor: Novo Nordisk A/S | Expected completion: 2026-06-02 | Status: Active Not Recruiting | Last update: 2026-06-09

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