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Trial · Interventional

CompletedPhase 3Registry data

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin

Short name REIMAGINE 3

NCTNCT06323161 (opens ClinicalTrials.gov in a new tab)Other idNN9388-7637Other idU1111-1283-0754Other id2022-502679-43
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
274 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
6 countries

United States, China, Japan, Serbia, Slovakia, South Africa

Start
26 Mar 2024
Primary completion
9 Sept 2025
Completion
23 Oct 2025
First posted
21 Mar 2024
Last update posted
9 Sept 2026
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 3

    REIMAGINE 3

    NCT06323161

    26 Mar 2024 to 23 Oct 2025

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 helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.

Interventions

  • CagrilintideDrug
  • SemaglutideDrug
  • PlaceboDrug

Arms4

  • Active comparator

    CagriSema Dose 1

    Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks.

  • Active comparator

    CagriSema Dose 2

    Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 24 weeks.

  • Placebo comparator

    Placebo Dose 1

    Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 40 weeks.

  • Placebo comparator

    Placebo Dose 2

    Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 40 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Glycated Haemoglobin (HbA1c)

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured in percentage (%)- points.

Secondary outcomes(20)

  1. Relative Change in Body Weight

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured in percentage (%).

  2. Number of Participants Who Achieve Greater than or Equal to (≥) 10% Body Weight Reduction

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured as count of participants.

  3. Number of Participants Who Achieve ≥15% Body Weight Reduction

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured as count of participants.

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

    Time frame · At end of treatment (week 40)

    Registry description

    Measured as count of participants.

  5. 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 40)

    Registry description

    Measured as count of participants.

  6. Change in Fasting Plasma Glucose (FPG)

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured as millimole per liter (mmol/L).

  7. Change in Insulin Dose

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured in units (u).

  8. Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units

    Time frame · At end of treatment (week 40)

    Registry description

    Measured as count of participants.

  9. Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals)

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured in mmol/L.

  10. Number of Participants Who Achieve ≥5% Body Weight Reduction

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured as count of participants.

  11. Number of Participants Who Achieve ≥20% Body Weight Reduction

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured as count of participants.

  12. Change in Waist Circumference

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured in centimeter (cm).

  13. Change in Systolic Blood Pressure (SBP)

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured in millimeter of mercury (mmHg).

  14. Change in Diastolic Blood Pressure (DBP)

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured in mmHg.

  15. Ratio to Baseline in High Sensitivity C-reactive Protein (hsCRP)

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured in ratio.

  16. Ratio to Baseline in Lipids: Non-high Density Lipoprotein (Non-HDL) Cholesterol

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured in ratio.

  17. Ratio to Baseline in Lipids: Triglycerides

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured in ratio.

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

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured in ratio.

  19. Ratio to Baseline in Lipids: Very Low-Density Lipoprotein (VLDL) cholesterol

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured in ratio.

  20. Ratio to Baseline in Lipids: HDL Cholesterol

    Time frame · From baseline (week 0) to end of treatment (week 40)

    Registry description

    Measured in ratio.

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.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

14 results

Cagrilintide-semaglutide (CagriSema) as an add-on to basal insulin in adults with type 2 diabetes (REIMAGINE 3): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study.

Rosenstock et al. 2026Lancet (London, England)cited by 5

PMID 42251856DOI 10.1016/s0140-6736(26)01022-6PUB-42251856

Full text at the publisher14 results
Publisher pageSee results (14)

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 ≥180 days before screening. * On stable once-daily dose of basal insulin (minimum of 0.25 units per kilogram per day (U/kg/day) or 20 U/day) alone or in combination with metformin (at effective or maximum tolerated dose as judged by the investigator) for 90 days prior to screening. * 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 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 (eGFR) less than 30 milliliters per minute per 1.73 square meter (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. * 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. * Known hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8. * Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

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