CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,200 enrolled
Drug / intervention
Cagrilintide +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05394519
NCT05394519Phase 3Completed

Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity and Type 2 Diabetes

Novo Nordisk A/S·interventional·Posted May 27, 2022·Updated Jan 28, 2026

In Brief

A Phase 3 clinical trial evaluating Cagrilintide, Semaglutide, and 2 other interventions for Overweight and 2 related conditions. Completed, enrolled 1,200 participants across 179 sites in 13 countries.

Detailed Summary

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Canada, Germany, Hungary, India, Ireland, Japan, Malaysia, Poland, Puerto Rico, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMay 27, 2022
Enrollment StartFeb 1, 2023
Primary CompletionJan 28, 2025
Study CompletionFeb 3, 2025
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.1 years ago

Interventions

Cagrilintidedrug

Cagrilintide administered subcutaneously (s.c., under the skin) once-weekly

Semaglutidedrug

Semaglutide administered subcutaneously (s.c., under the skin) once-weekly

Placebo cagrilintidedrug

Placebo cagrilintide administered subcutaneously (s.c., under the skin) once-weekly

Placebo semaglutidedrug

Placebo semaglutide administered subcutaneously (s.c., under the skin) once-weekly