A Placebo-controlled Comparability Study to Compare Two Presentations of CagriSema in Participants With Overweight or Obesity

Clinical Trial25 Feb 2026Phase 3● 6/10i

A Placebo-controlled Comparability Study to Compare Two Presentations of CagriSema in Participants With Overweight or Obesity

Novo Nordisk A/S

Phase 3 trial compares two presentation formats of CagriSema (cagrilintide plus semaglutide) delivered via different injection devices for weight loss in adults with overweight or obesity. The placebo-controlled study plans to enroll 1,400 participants with completion expected in late 2027. This device comparability study reflects Novo Nordisk's preparation for potential CagriSema approval, ensuring multiple delivery options for their dual hormone approach. The timing suggests Novo is advancing toward late-stage regulatory preparations for their next-generation weight management therapy.

Strategic Signal

Novo Nordisk is conducting device optimization ahead of potential CagriSema commercialization, mirroring the multi-device strategy that supported Ozempic and Wegovy market penetration. Device comparability data will be essential for FDA submission completeness and formulary positioning against Eli Lilly's Zepbound single-device presentation. This suggests Novo anticipates 2028-2029 launch timing for CagriSema, positioning dual amylin/GLP-1 agonism as their competitive response to tirzepatide's dual GIP/GLP-1 mechanism.

GLP-1Weight lossNovo Nordisk

Original Abstract

This study is being done to find out how well a medicine called CagriSema helps people with overweight or obesity lose weight. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance using a computer program, so neither participants nor study staff will know which treatment is given. The study will last for about one year. | Condition(s): Overweight; Obesity | Primary endpoint(s): Relative change in body weight | Enrollment: 1,400 (estimated) | Phase: Phase 3 | Sponsor: Novo Nordisk A/S | Expected completion: 2027-11-29 | Status: Not Yet Recruiting | Last update: 2026-02-25

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