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Trial · Interventional

CompletedPhase 3Registry data

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

Short name REIMAGINE 2

NCTNCT06065540 (opens ClinicalTrials.gov in a new tab)Other idNN9388-4896Other idU1111-1283-0427Other id2022-502678-18
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
2,734 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
30 countries

United States, Argentina, Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czechia, Denmark, Finland, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Romania, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Taiwan

Start
27 Sept 2023
Primary completion
19 Nov 2025
Completion
6 Jan 2026
First posted
4 Oct 2023
Last update posted
8 Jul 2026
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024202520262027
  1. Ph 3

    REIMAGINE 2

    NCT06065540

    27 Sept 2023 to 6 Jan 2026

Registry summary

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

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).

Interventions

  • CagrilintideDrug
  • SemaglutideDrug
  • Placebo cagrilintideDrug
  • Placebo semaglutideDrug

Arms7

  • Experimental

    CagriSema Dose 1

    Participants will receive once-weekly subcutaneous (s.c) injections of cagrilintide dose 1 and semaglutide dose 1 for 68 weeks.

  • Experimental

    CagriSema Dose 2

    Participants will receive once-weekly s.c injections of cagrilintide dose 2 and semaglutide dose 2 for 68 weeks.

  • Active comparator

    Semaglutide Dose 1

    Participants will receive once-weekly s.c injection of semaglutide dose 1 for 68 weeks.

  • Active comparator

    Semaglutide Dose 2

    Participants will receive once-weekly s.c injection of semaglutide dose 2 for 68 weeks.

  • Active comparator

    Cagrilintide Dose 1

    Participants will receive once-weekly s.c injection of cagrilintide dose 1 for 68 weeks.

  • Placebo comparator

    Placebo Dose 1

    Participants will receive once-weekly s.c injection of placebo matched to cagrilintide dose 1 and semaglutide dose 1 for 68 weeks.

  • Placebo comparator

    Placebo Dose 2

    Participants will receive once-weekly s.c injection of placebo matched to cagrilintide dose 2 and semaglutide dose 2 for 68 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    Measured in percentage-points.

Secondary outcomes(20)

  1. CagriSema versus cagrilintide: Change in HbA1c

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    Measured in percentage-points.

  2. CagriSema versus cagrilintide: Relative change in body weight

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    Measured in percentage.

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

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    Measured in percentage-points.

  4. CagriSema versus semaglutide: Relative change in body weight

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    Measured in percentage.

  5. Cagrilintide versus placebo: Change in HbA1c

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    Measured in percentage-points.

  6. Cagrilintide versus placebo: Relative change in body weight

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    Measured in percentage.

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

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    Measured as count of participants.

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

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    Measured as count of participants.

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

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    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])

    Time frame · From baseline (week -3) to end of treatment (week 68)

    Registry description

    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)

    Time frame · From baseline (week -3) to end of treatment (week 68)

    Registry description

    Measured in percentage-points.

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

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    Measured in millimeters of mercury (mmHg).

  13. CagriSema versus semaglutide: Ratio to baseline in triglycerides

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    Measured as ratio of triglycerides.

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

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    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)

    Time frame · From baseline (week -3) to end of treatment (week 68)

    Registry description

    Measured in percentage-points.

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

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    Measured as ratio of hsCRP.

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

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    Measured in mmol/L.

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

    Time frame · At end of treatment (week 68)

    Registry description

    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)

    Time frame · At end of treatment (week 68)

    Registry description

    Measured as count of participants.

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

    Time frame · From baseline (week 0) to end of treatment (week 68)

    Registry description

    Measured in percentage-points.

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

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2026

Corrected

Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study.

Buse et al. 2026The lancet. Diabetes & endocrinologycited by 7

PMID 42251859DOI 10.1016/s2213-8587(26)00125-7PUB-42251859

Full text at the publisher
Publisher pageRead the notice

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) 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. Exclusion Criteria: * 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.

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