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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 Diet and Exercise

Short name REIMAGINE 1

NCTNCT06323174 (opens ClinicalTrials.gov in a new tab)Other idNN9388-4895Other id2022-502677-42Other idU1111-1283-0404
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States, China, Hungary, Italy, Poland, Saudi Arabia, Serbia

Start
19 Mar 2024
Primary completion
1 Oct 2025
Completion
22 Dec 2025
First posted
21 Mar 2024
Last update posted
30 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 1

    NCT06323174

    19 Mar 2024 to 22 Dec 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 participants 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. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.

Interventions

  • CagrilintideDrug
  • SemaglutideDrug
  • PlaceboDrug

Arms4

  • Active comparator

    CagriSema Dose 2

    Participants will receive once-weekly subcutaneous (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 2

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

  • 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.

  • Placebo comparator

    Placebo Dose 1

    Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 1 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 as 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 %.

  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 millimoles 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 in millimoles per liter (mmol/L).

  7. 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.

  8. 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.

  9. Change in waist circumference

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

    Registry description

    Measured in centimeters (cm).

  10. Change in systolic blood pressure (SBP)

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

    Registry description

    Measured in millimeters of mercury (mmHg).

  11. Change in diastolic blood pressure (DBP)

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

    Registry description

    Measured in mmHg.

  12. 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 as ratio.

  13. Ratio to baseline in lipids: Total cholesterol

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

    Registry description

    Measured as ratio.

  14. Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol

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

    Registry description

    Measured as ratio.

  15. 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 as ratio.

  16. 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 as ratio.

  17. Ratio to baseline in lipids: Triglycerides

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

    Registry description

    Measured as ratio.

  18. Ratio to baseline in lipids: Free fatty acids

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

    Registry description

    Measured as ratio.

  19. Ratio to baseline in lipids: Non-HDL cholesterol

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

    Registry description

    Measured as ratio.

  20. Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication)

    Time frame · At end of study (week 52)

    Registry description

    Measured as count of participants.

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

13 results

Efficacy and safety of once-weekly cagrilintide-semaglutide (CagriSema) in adults with type 2 diabetes inadequately controlled on diet and exercise (REIMAGINE 1): a randomised, double-blind, placebo-controlled, phase 3a study.

Aroda et al. 2026The lancet. Diabetes & endocrinologycited by 2

PMID 42251860DOI 10.1016/s2213-8587(26)00126-9PUB-42251860

Full text at the publisher13 results
Publisher pageSee results (13)

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 * Age 18 years or above at the time of signing the informed consent * Diagnosed with type 2 diabetes \>=30 days before screening * HbA1c 7.0-9.5 percent (53-80 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening * Body mass index (BMI) \>=23 kilograms 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 medication for the indication of diabetes or obesity 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 * History of use of any injectable therapy for diabetes or obesity. 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 a fundus 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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