REIMAGINE 5

Active not recruitingPhase 3

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide / Tirzepatide

Listed sites

163

Recruiting sites

—

Enrollment

1,023

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥30•HbA1c 7-10.5%

Primary endpoints

•HbA1c, change•Body weight, % change

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 IDNCT06534411

Org study IDNN9388-7741

Secondary ID2023-509600-15European Medical Agency (EMA)

Secondary IDU1111-1300-2590World Health Organization (WHO)

Timeline

Milestones

Study first posted2024-08-02actual

Study start2024-11-05actual

Last update posted2026-05-05actual

Primary completion2026-06-02estimated

Study completion2026-07-14estimated

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female (sex at birth).

•Age 18 years or above at the time of signing the informed consent.

•Diagnosed with type 2 diabetes mellitus greater than or equal to (>=) 180 days before screening.

•Stable daily dose(s) >= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:

•Metformin

•sodium-glucose co-transporter 2 inhibitor (SGLT2i)

•Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol [mmol/mol]) (both inclusive) as determined by central laboratory at screening.

•Body mass index (BMI) >= 30 kilogram per square meter (kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.

•Renal impairment with estimated Glomerular Filtration Rate less than < 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) as determined by central laboratory at screening.

•Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is allowed.

•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye 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 (27)

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

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

6 endpoints

Primary/protocol endpoint

Relative Change in Body Weight

Time frame:From baseline (week 0) to end of treatment (week 60)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Who Achieve Greater Than or Equal to (>=) 5% Weight Reduction

Time frame:From baseline (week 0) to end of treatment (week 60)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieve >= 10% Weight Reduction

Time frame:From baseline (week 0) to end of treatment (week 60)

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieve >= 15% Weight Reduction

Time frame:From baseline (week 0) to end of treatment (week 60)

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieve >= 20% Weight Reduction

Time frame:From baseline (week 0) to end of treatment (week 60)

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:From baseline (week 0) to end of treatment (week 60)

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Change in Glycated Haemoglobin (HbA1c)

Time frame:From baseline (week 0) to end of treatment (week 60)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c

Time frame:From baseline (week 0) to end of treatment (week 60)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:From baseline (week 0) to end of treatment (week 60)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Number of Participants Who Achieve HbA1c Target Values of Less Than (<) 7.0 (Percent [%]) (< 53 millimole per mole [mmol/mol])

Time frame:At end of treatment (week 60)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants Who Achieve HbA1c Target Values of Less Than or Equal to (<=) 6.5% (<= 48 mmol/mol)

Time frame:At end of treatment (week 60)

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

8 endpoints

Secondary/protocol endpoint

Change in Systolic Blood Pressure (SBP)

Time frame:From baseline (week 0) to end of treatment (week 60)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Diastolic Blood Pressure (DBP)

Time frame:From baseline (week 0) to end of treatment (week 60)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Ratio to Baseline in Lipids: Total Cholesterol

Time frame:From baseline (week 0) to end of treatment (week 60)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol

Time frame:From baseline (week 0) to end of treatment (week 60)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol

Time frame:From baseline (week 0) to end of treatment (week 60)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol

Time frame:From baseline (week 0) to end of treatment (week 60)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline in Lipids: Triglycerides

Time frame:From baseline (week 0) to end of treatment (week 60)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Ratio to Baseline in Lipids: Non-HDL cholesterol

Time frame:From baseline (week 0) to end of treatment (week 60)

Non-HDL cholesterol, change

ratio, improvement

Patient-reported / QoL

5 endpoints

Secondary/protocol endpoint

Change in Short Form (SF) -36v2 Score: Physical Component Summary Score

Time frame:From baseline (week 0) to end of treatment (week 60)

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36v2 Score: Mental Component Summary Score

Time frame:From baseline (week 0) to end of treatment (week 60)

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36v2 Score: Vitality Subscale

Time frame:From baseline (week 0) to end of treatment (week 60)

change from baseline, improvement

Secondary/protocol endpoint

Change in Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQOL-Lite-CT) : Physical Function score

Time frame:From baseline (week 0) to end of treatment (week 60)

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT: Total score

Time frame:From baseline (week 0) to end of treatment (week 60)

IWQOL-Lite total

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to end of study (week 66)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (<54 Milligram per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter

Time frame:From baseline (week 0) to end of study (week 66)

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

Time frame:From baseline (week 0) to end of study (week 66)

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.