Suspended

REDEFINE 1CagriSema for Weight Loss in Participants with Overweight or Obesity

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Study Aim

This phase 3 study aims to evaluate the effectiveness of CagriSema for weight loss in individuals with overweight or obesity, by comparing it to a placebo in terms of achieving at least 5% weight reduction and relative change in body weight.

What is being tested

Cagrilintide

+ Placebo semaglutide

+ Semaglutide

Drug
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: November 2022
See protocol details

Summary

Principal SponsorNovo Nordisk A/S
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2022

Actual date on which the first participant was enrolled.

This study focuses on treating individuals with overweight or obesity. The main goal is to test the effectiveness and safety of a new medication called CagriSema, which is a combination of Cagrilintide and Semaglutide. This study compares CagriSema to a placebo (a 'dummy' medicine) and to the individual medications, Cagrilintide and Semaglutide. The purpose is to understand if CagriSema helps participants lose weight more effectively than these other options. This research is important as it could potentially provide a new treatment option for those struggling with excess body weight and related health issues. During the main part of the study, participants receive one of four possible treatments, decided by chance. They will take one injection once a week, typically in the stomach, thighs, or upper arms. The main study lasts for about 1½ years. After this, some participants may continue to an extension study where they will not receive any study medicine. The extension study aims to understand what happens to the participant's body weight and related diseases after stopping the study medicine. The results are measured by counting the number of participants who achieve a weight reduction of 5% or more, and by calculating the relative change in body weight, both measured in percentage (%).

Official TitleEfficacy and Safety of Cagrilintide s.c. 2.4 Milligram (mg) in Combination With Semaglutide Subcutaneous (s.c). 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity
NCT05567796
Principal SponsorNovo Nordisk A/S
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

3 inclusion criteria required to participate
Male or female
Age above or equal to 18 years at the time of signing informed consent
Body mass index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m\^2) or b) BMI greater than or equal to 27.0 kg/m\^2 with the presence of at least one weight-related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
1 exclusion criteria prevent from participating
Glycaemia related: a) Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening b) History of type 1 or type 2 diabetes mellitus

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Participants will receive cagrilintide s.c. and placebo matching to semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks.

Group II

Experimental
Participants will receive cagrilintide and semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for 97 weeks.

Group III

Active Comparator
Participants will receive semaglutide s.c.and placebo matched to cagrilintide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks.

Group IV

Placebo
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeks. Participants randomised to this arm will be included in the extension phase for 97 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 250 locations

Suspended

Univ of Alabama Birmingham

Birmingham, United StatesOpen Univ of Alabama Birmingham in Google Maps
Suspended

Velocity Clin Res Los Angeles

Los Angeles, United States
Suspended

Velocity Clin Res Wstlke

Los Angeles, United States
Suspended

Univ of Colorado at Denver

Aurora, United States
Suspended250 Study Centers