REDEFINE 6

CompletedPhase 3

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

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 Chinese Participants With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

300

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05996848

Org study IDNN9838-4827

Secondary IDU1111-1267-4364World Health Organization (WHO)

Timeline

Milestones

Study start2023-08-15actual

Study first posted2023-08-18actual

Primary completion2025-01-06actual

Study completion2025-02-22actual

Last update posted2026-01-09actual

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (28)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

Patient-reported / QoL

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

8 endpoints

Primary/protocol endpoint

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)

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

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)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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)

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

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)

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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)

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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)

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

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)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

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)

percent change from baseline, improvement

Cardiometabolic biomarkers

8 endpoints

Secondary/protocol endpoint

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)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

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)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

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)

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

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)

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

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)

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

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)

VLDL, change

percent change from baseline, improvement

Secondary/protocol endpoint

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)

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

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)

Free fatty acids, change

percent change from baseline, improvement

Patient-reported / QoL

5 endpoints

Secondary/protocol endpoint

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)

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

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)

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

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)

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

CagriSema 2.4 mg/2.4 mg versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOLLite- CT) Physical Function score

Time frame:From baseline (week 0) to end of treatment (week 44)

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT Total score

Time frame:From baseline (week 0) to end of treatment (week 44)

IWQOL-Lite total

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to end of study (week 51)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Serious Adverse Events (TESAEs)

Time frame:From baseline (week 0) to end of study (week 51)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of clinically significant hypoglycaemic episodes (level 2) (lesser than 3.0 mmol/L (54 milligrams per deciliter[mg/dL]), confirmed by BG meter) (only for participants with Type 2 diabetes (T2D) at screening)

Time frame:From baseline (week 0) to end of study (week 51)

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold (only for participants with T2D at screening)

Time frame:From baseline (week 0) to end of study (week 51)

Severe hypoglycemia

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.