Trial · Interventional

Active, not recruitingPhase 3Registry data

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

Short name REDEFINE 1

NCTNCT05567796Other idNN9838-4608Other idUniversal Trial Number (UTN)Other id2020-005435-75

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Active, not recruiting
Phase: Phase 3
Enrollment: 3,400 participants (estimated)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 23 countries
United States, Argentina, Australia, Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, India, Italy, Japan, Mexico, Netherlands, Poland, Serbia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Start: 1 Nov 2022
Primary completion: 30 Oct 2024
Completion: 19 Oct 2026 (estimated)
First posted: 5 Oct 2022
Last update posted: 30 Sept 2026
Conditions: Obesity

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202220232024202520262027

Ph 3
REDEFINE 1
NCT05567796
1 Nov 2022 to est. 19 Oct 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms. Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.

Interventions

CagrilintideDrug
SemaglutideDrug
Placebo cagrilintideDrug
Placebo semaglutideDrug

Arms4

Experimental
Cagrisema
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.
Active comparator
Cagrilintide
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.
Active comparator
Semaglutide
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.
Placebo comparator
Placebo s.c.
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.

Primary outcomes2

Outcomes the sponsor listed as primary.

CagriSema versus placebo: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in percentage (%)
CagriSema versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as count of participants

Secondary outcomes(20)

CagriSema versus placebo: Achievement of >= 20% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as count of participant
CagriSema versus placebo: Achievement of >= 25% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as count of participant
CagriSema versus placebo: Achievement of >= 30% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as count of participant
CagriSema versus cagrilintide and CagriSema versus semaglutide: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as percentage (%)
CagriSema versus placebo: Relative change in body weight
Time frame · From baseline (week 0) to week 8
Registry description
Measured as percentage (%)
CagriSema versus placebo: Relative change in body weight
Time frame · From baseline (week 0) to week 20
Registry description
Measured as percentage (%)
CagriSema versus placebo: Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in centimeters (cm)
CagriSema versus placebo: Change in systolic blood pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in millimeters of mercury (mmHg)
CagriSema versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.
CagriSema versus placebo: Change in SF-v2 Health Survey Acute (SF-36 v2 Acute) Physical Functioning Score
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as score points. The SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being.
CagriSema versus placebo, semaglutide and cagrilintide: Change in body weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in kilograms (kg)
CagriSema versus placebo, semalutide and cagrilintide: Change in body mass index (BMI)
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in kilogram per square meter (kg/m\^2)
CagriSema versus placebo, semaglutide and cagrilintide: Improvement in weight category
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as count of participants. The categories are: BMI, underweight less than (\<) 18.5, normal weight 18.5 to \<25, overweight 25.0 to \<30, obesity class I 30 to \< 35, obesity class II 35 to \< 40, obesity class III \>40.
CagriSema versus placebo: Change in Glycated Haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as percentage (%)
CagriSema versus placebo: Change in HbA1c
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as millimoles per mole (mmol/mol).
CagriSema versus placebo: Change in Fasting Plasma Glucose (FPG) (mmol/L).
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as millimoles per liter (mmol/L).
CagriSema versus placebo: Change in FPG (mg/dL)
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as milligrams per deciliter (mg/dL).
CagriSema versus placebo: Ratio to baseline in fasting serum insulin
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as ratio
CagriSema versus placebo: Change in Diastolic Blood Pressure (DBP)
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in mmHg
CagriSema versus placebo: Ratio to baseline in total cholesterol
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as ratio

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2026

10 results

CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1.

Verma et al. 2026Hypertension (Dallas, Tex. : 1979)cited by 4

PMID 41328546PMC12822771DOI 10.1161/hypertensionaha.125.26055PUB-41328546

Free to read · publisher termsCC BY-NC-ND10 results

Read at source See results (10)

Indexing hint: Randomized controlled trial · 2025

12 results

Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity.

Garvey et al. 2025The New England journal of medicinecited by 149

PMID 40544433DOI 10.1056/nejmoa2502081PUB-40544433

Full text at the publisher12 results

Publisher page See results (12)

Eligibility

Who could join, as posted.

Sex: All
Age: Not stated
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 Exclusion Criteria: \- 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

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