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

Short name REIMAGINE 5

NCTNCT06534411Other idNN9388-7741Other idU1111-1300-2590Other id2023-509600-15Other id2023

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 1,023 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Open label (no masking)
Countries: 14 countries
United States, Argentina, Australia, Brazil, Canada, Germany, Greece, Hungary, India, Israel, Poland, Romania, Spain, Taiwan
Start: 5 Nov 2024
Primary completion: 2 Jun 2026
Completion: 9 Jul 2026
First posted: 2 Aug 2024
Last update posted: 9 Sept 2026
Conditions: Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

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

2024202520262027

Ph 3
REIMAGINE 5
NCT06534411
5 Nov 2024 to 9 Jul 2026

Registry summary

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

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

Interventions

CagrilintideDrug
SemaglutideDrug
TirzepatideDrug

Arms2

Experimental
CagriSema
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 8-week dose escalation period until target dose of CagriSema is achieved and maintained for 52 weeks.
Experimental
Tirzepatide
Participants will receive once-weekly s.c injections of tirzepatide at escalating dose in a 4-week dose escalating period and maintained up to 56 weeks.

Primary outcomes2

Outcomes the sponsor listed as primary.

Change in Glycated Haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured in percentage points.
Relative Change in Body Weight
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured in percentage (%).

Secondary outcomes(20)

Change in HbA1c
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured in percentage points.
Change in Fasting Plasma Glucose (FPG)
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured as millimole per liter (mmol/L).
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)
Registry description
Measured as count of participants.
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)
Registry description
Measured as count of participants.
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)
Registry description
Measured as count of participants.
Number of Participants Who Achieve >= 10% Weight Reduction
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured as count of participants.
Number of Participants Who Achieve >= 15% Weight Reduction
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured as count of participants.
Number of Participants Who Achieve >= 20% Weight Reduction
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured as count of participants.
Change in Systolic Blood Pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured in millimeter of mercury (mmHg).
Change in Diastolic Blood Pressure (DBP)
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured in mmHg.
Change in Waist Circumference
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured in centimeter (cm).
Ratio to Baseline in Lipids: Total Cholesterol
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured as ratio.
Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured as ratio.
Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured as ratio.
Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured as ratio.
Ratio to Baseline in Lipids: Triglycerides
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured as ratio.
Ratio to Baseline in Lipids: Non-HDL cholesterol
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured as ratio.
Change in Short Form (SF) -36v2 Score: Physical Component Summary Score
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured as score points. 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. Physical component summary scores ranges from 6.1 to 79.7 with higher scores indicating better functional health and well-being.
Change in SF-36v2 Score: Mental Component Summary Score
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured as score points. 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. Mental component summary scores ranges from -3.8 to 78.7 with higher scores indicating better functional health and well-being.
Change in SF-36v2 Score: Vitality Subscale
Time frame · From baseline (week 0) to end of treatment (week 60)
Registry description
Measured as score points. 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. Vitality score ranges from 25.6 to 69.1 with higher scores indicating better functional health and well-being.

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 (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.

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