A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

NCT06065540
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Phase
Phase 3
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Recruitment status
Completed
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Participants
2,734
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Lead sponsor
Novo Nordisk A/S
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Start date
2023-09-27
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Number of sites
405
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Summary
The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).
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Acronym
REIMAGINE 2
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Short title
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
clinicaltrials.gov
Official title
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4/2.4 mg and 1.0/1.0 mg Once Weekly Versus Semaglutide 2.4 mg and 1.0 mg, Cagrilintide 2.4 mg and Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-01-06
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First posted
2023-10-04
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Registry last updated
2026-07-08
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Primary completion date
2025-11-19
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Start date
2023-09-27
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Actual participants
2,734
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Participants
2,734
clinicaltrials.gov
Participant count basis
Actual
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Protocol amendments
2
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Number of sites
405
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Novo Nordisk A/S
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06065540
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ClinicalTrials.gov ID
NCT06065540
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. CagriSema (dose 1) versus semaglutide (dose 1): Change in glycated haemoglobin (HbA1c)

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage-points.

  1. CagriSema versus cagrilintide: Change in HbA1c

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage-points.

  2. CagriSema versus cagrilintide: Relative change in body weight

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage.

  3. CagriSema (dose 1) versus semaglutide (dose 2): Change in HbA1c

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage-points.

  4. CagriSema versus semaglutide: Relative change in body weight

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage.

  5. Cagrilintide versus placebo: Change in HbA1c

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage-points.

  6. Cagrilintide versus placebo: Relative change in body weight

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage.

  7. CagriSema versus semaglutide: Achievement of greater than or equal to (>=) 10 percent (%) weight reduction

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured as count of participants.

  8. CagriSema versus semaglutide: Achievement of >= 15 % weight reduction

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured as count of participants.

  9. CagriSema versus semaglutide: Achievement of >= 20 % weight reduction

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured as count of participants.

  10. CagriSema (pooled doses) versus semaglutide (pooled doses): Continuous Glucose Monitoring (CGM) - Change in Time in Range (TIR) 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre [mg/dL])

    Timeframe: From baseline (week -3) to end of treatment (week 68)

    Measured in percentage-points.

  11. CagriSema versus semaglutide: CGM - Change in time in Tight Target Range (TITR) 3.9-7.8 (mmol/L) (70-140 mg/dL)

    Timeframe: From baseline (week -3) to end of treatment (week 68)

    Measured in percentage-points.

  12. CagriSema versus semaglutide: Change in Systolic Blood Pressure (SBP)

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured in millimeters of mercury (mmHg).

  13. CagriSema versus semaglutide: Ratio to baseline in triglycerides

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio of triglycerides.

  14. CagriSema versus semaglutide: Ratio to baseline in non-High Density Lipoprotein (HDL) cholesterols

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio of non-HDL cholesterol.

  15. CagriSema versus semaglutide: CGM - Change in Time In Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)

    Timeframe: From baseline (week -3) to end of treatment (week 68)

    Measured in percentage-points.

  16. CagriSema versus semaglutide: Ratio to baseline in high sensitivity C-Reactive Protein (hsCRP)

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio of hsCRP.

  17. CagriSema versus semaglutide: Change in Fasting Plasma Glucose (FPG)

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured in mmol/L.

  18. CagriSema versus semaglutide: Achievement of HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol])

    Timeframe: At end of treatment (week 68)

    Measured as count of participants.

  19. CagriSema versus semaglutide: Achievement of HbA1c target values of less than or equal to (≤)6.5% (≤48 mmol/mol)

    Timeframe: At end of treatment (week 68)

    Measured as count of participants.

  20. CagriSema versus semaglutide: CGM - Change in time above range, >10.0 mmol/L (>180 mg/dL)

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage-points.

  21. CagriSema versus semaglutide: CGM - Change in time above range, >13.9 mmol/L (>250 mg/dL)

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage-points.

  22. CagriSema versus semaglutide: CGM - Within-day glycaemic variability (% coefficient of variation [CV])

    Timeframe: At end of treatment (week 68)

    Measured in percentage.

  23. CagriSema versus semaglutide: Achievement of ≥ 5 % weight reduction

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured as count of participants.

  24. CagriSema versus semaglutide: Change in waist circumference

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured in centimetre.

  25. CagriSema versus semaglutide: Change in Diastolic Blood Pressure (DBP)

    Timeframe: From baseline (week 0) to end of treatment (week 68)

    Measured in mmHg.

And 12 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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) greater than or equal to 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 with or without Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors.
  • Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening.
  • Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square metre (mL/min/1.73 m^2) as determined by central laboratory at screening.
  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are 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.
Sources for eligibility
clinicaltrials.gov

  • Synexus Clin Res-BirminghamBirmingham, United States
  • Univ of Alabama_BirminghamBirmingham, United States
  • Cahaba ResearchPelham, United States
  • Velocity Clinical Research-PhoenixPhoenix, United States
  • Synexus Rsch /Cnt Phnx Med CPhoenix, United States
  • Arkansas Clinical ResearchLittle Rock, United States
  • Velocity Clinical Res-BanningBanning, United States
  • Velocity Clin Res-Chula VistaChula Vista, United States
  • John Muir Physicians NetworkConcord, United States
  • Headlands Research California, LLCEscondido, United States
  • Velocity Clin Res GardenaGardena, United States
  • Velocity Clin Res San DiegoLa Mesa, United States
  • Loma Linda Univ Hlth Cr EndoLoma Linda, United States
  • Facey Medical FoundationMission Hills, United States
  • Desert Oasis Hlthcr Med GroupPalm Springs, United States
  • Velocity Clin Res- San BernSan Bernardino, United States
  • Linda Vista Health Care CtrSan Diego, United States
  • Velocity Clin Res Santa AnaSanta Ana, United States
  • Premier Medical Center, Inc.Toluca Lake, United States
  • Velocity Clin Res - PanoramaVan Nuys, United States
  • Optumcare Clinical Trials,LLC-GoldenColorado Springs, United States
  • Northeast Research InstituteJacksonville, United States
  • Clinical Trial Services CorpMiami, United States
  • Bioclinical Research AllianceMiami, United States
  • New Horizon Research CenterMiami, United States

And 380 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2022-502678-18
  • U1111-1283-0427
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (1)