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

Short name REDEFINE 6

NCTNCT05996848Other idNN9838-4827Other idU1111-1267-4364

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 300 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Double masking
Countries: 1 country
China
Start: 15 Aug 2023
Primary completion: 6 Jan 2025
Completion: 22 Feb 2025
First posted: 18 Aug 2023
Last update posted: 9 Jan 2026
Conditions: Obesity or Overweight

Timeline

1 trial · 1 completed

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

2023202420252026

Ph 3
REDEFINE 6
NCT05996848
15 Aug 2023 to 22 Feb 2025

Registry summary

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

This study will look at how well the new medicine CagriSema helps people with excess body weight losing weight compared to a "dummy" medicine and a medicine called semaglutide. Participants will either get CagriSema, a dummy medicine or semaglutide. Which treatment participants get is decided by chance. Participants will take one injection once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1 year.

Interventions

CagrilintideDrug
SemaglutideDrug
Placebo SemaglutideDrug
Placebo CagrilintideDrug

Arms3

Experimental
CagriSema
Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.
Active comparator
Semaglutide
Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.
Placebo comparator
Placebo
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.

Primary outcomes2

Outcomes the sponsor listed as primary.

CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 5%
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured as count of participants

Secondary outcomes(20)

CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 20%
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured as count of participants
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in centimeter (cm)
CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 10%
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured as count of participants
CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 15%
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured as count of participants
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in centimeter (cm)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Glycated Haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in percentage points
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Fasting Plasma Glucose (FPG)
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured as millimole per liter (mmol/L)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in fasting serum insulin
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Systolic Blood Pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in millimeter of mercury (mmHg)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Diastolic Blood Pressure (DBP)
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in millimeter of mercury (mmHg)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in total cholesterol
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in high-density lipoprotein (HDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in low-density lipoprotein (LDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in very low-density lipoprotein (VLDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in triglycerides
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in free fatty acids
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Short Form-36 Version 2.0 (SF- 36v2) Physical Functioning score
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured as score points. The SF-36v2.0 is a 36-item commonly used generic clinical outcome assessment (COA) instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'physical functioning domain'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 correspond to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.
CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Physical Component Summary Score
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured as score points. The SF-36v2.0 is a 36-item commonly used generic COA instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'physical component summary'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.
CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Mental Component Summary score
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured as score points. The SF-36v2.0 is a 36-item commonly used generic COA instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'mental component summary'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.

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.

Completed trials do not always post results.

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
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 1. Body Mass Index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m\^2) or 2. 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, type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease For participants with Type 2 diabetes (T2D) at screening the following criteria also apply: * Diagnosed with type 2 diabetes mellitus greater than equal to 180 days before screening * Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i)), thiazolidinediones, or sulphonylureas (SUs) as a single agent or in combination) according to local label * Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 60 days before screening * Glycated Haemoglobin (HbA1c) 7 percent-10 percent (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as measured by the central laboratory at screening Exclusion Criteria: For participants without T2D at screening: * HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening * History of type 1 or type 2 diabetes mellitus For participants with T2D at screening: * Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness * Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (mL/min/1.73 m\^2), as measured by the central laboratory at screening * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

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