A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

NCT05394519 · Completed

Last updated 2026-05-28

This study is testing whether the medication CagriSema helps people with type 2 diabetes and excess body weight lose weight.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 1,200 people

Who can join Ages 18+ · all sexes

Timeline Started 2023-02 · est. completion 2025-02

Where 179 sites · Austria, Canada, Germany, Hungary, India, Ireland, Japan, Malaysia, Poland, Puerto Rico, Thailand, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT05394519 ↗

Description as written by the study sponsor.

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.

Treatments tested

Cagrilintide Drug

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

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

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

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

Main thing measured	Relative change in body weight
Sponsor	Novo Nordisk A/S
Conditions studied	Overweight, Obesity, Type 2 Diabetes Mellitus
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05394519 ↗