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Trial · Interventional

CompletedPhase 3Registry data

A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

Short name REDEFINE 2

NCTNCT05394519 (opens ClinicalTrials.gov in a new tab)Other idNN9838-4609Other idU1111-1267-4287Other id2021-005121-24Other idjRCT2031220671
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,200 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
13 countries

United States, Austria, Canada, Germany, Hungary, India, Ireland, Japan, Malaysia, Poland, Puerto Rico, Thailand, United Kingdom

Start
1 Feb 2023
Primary completion
28 Jan 2025
Completion
3 Feb 2025
First posted
27 May 2022
Last update posted
28 Jan 2026
Conditions
Overweight · Obesity · Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 3

    REDEFINE 2

    NCT05394519

    1 Feb 2023 to 3 Feb 2025

Registry summary

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

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Interventions

  • CagrilintideDrug
  • SemaglutideDrug
  • Placebo cagrilintideDrug
  • Placebo semaglutideDrug

Arms2

  • Experimental

    CagriSema

    Cagrilintide + semaglutide once weekly

  • Placebo comparator

    Placebo

    Placebo cagrilintide + semaglutide once weekly

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Relative change in body weight

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

    Registry description

    Measured in percentage (%).

  2. Achievement of greater than or equal to (≥) 5% weight reduction

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

    Registry description

    Count of participant.

Secondary outcomes(20)

  1. Achievement of ≥ 20% weight reduction

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

    Registry description

    Count of participant.

  2. Relative change in body weight

    Time frame · From baseline (week 0) to week 20

    Registry description

    Measured in %.

  3. Change in waist circumference

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

    Registry description

    Measured in centimeter (cm).

  4. Change in Glycated Haemoglobin (HbA1c)

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

    Registry description

    Measured in %-points.

  5. Change in Systolic Blood Pressure (SBP)

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

    Registry description

    Measured in millimeter of mercury (mmHg).

  6. Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score

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

    Registry description

    Measured in score points.

  7. Change in Short Form-36 Version 2.0 Health Survey Acute (SF-36v2 Acute) Physical Functioning score

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

    Registry description

    Measured in score points.

  8. Change in body weight

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

    Registry description

    Measured in kilogram (kg).

  9. Change in body mass index (BMI)

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

    Registry description

    Measured in kilogram per meter square (kg/m\^2).

  10. Improvement in weight category (BMI, underweight below 18.5, normal weight 18.5 to below 25, overweight 25.0 to below 30, obesity class I 30 to below 35, obesity class II 35 to below 40, obesity class III above 40)

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

    Registry description

    Count of participant.

  11. Achievement of HbA1c less than or equal to (≤) 6.5%

    Time frame · At end of treatment (week 68)

    Registry description

    Count of participant.

  12. Change in Fasting Plasma Glucose (mmol/L)

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

    Registry description

    Measured in millimoles per liter (mmol/L).

  13. Change in Fasting Plasma Glucose (mg/dL)

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

    Registry description

    Measured in milligram per deciliter (mg/dL)

  14. Ratio to baseline in fasting serum insulin

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

    Registry description

    Measured in ratio.

  15. Change in Diastolic Blood Pressure (DBP)

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

    Registry description

    Measured in mmHg.

  16. Ratio to baseline in C-reactive protein (CRP)

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

    Registry description

    Measured in ratio.

  17. Ratio to baseline in lipids: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Very low-density lipoprotein (VLDL) cholesterol, Triglycerides and Free fatty acids

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

    Registry description

    Measured in ratio.

  18. Change in IWQOL-Lite-CT: Total score, Physical and Psycosocial score

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

    Registry description

    IWQOL-Lite-CT is a 20-item clinical outcomes assessment (COA) instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. Score ranges for composite score (physical composite, psychosocial composite and physical function composite) and Total score is 0-100. Higher scores indicate better level of functioning.

  19. Change in Control of Eating Questionnaire (CoEQ): Craving Control score, Positive Mood score, Craving for Sweet score, Craving for Savoury food score, Hunger score and Satiety score

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

    Registry description

    CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). Higher score represents a greater level of Craving Control.

  20. Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score

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

    Registry description

    Count of participant.

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 · 2025

14 results

Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes.

Davies et al. 2025The New England journal of medicinecited by 77

PMID 40544432DOI 10.1056/nejmoa2502082PUB-40544432

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 * Age above or equal to 18 years at the time of signing informed consent * BMI greather than or equal to 27.0 kg/m\^2 * Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening * Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label * Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening * HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening Exclusion Criteria: * Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness * Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2, as measured by the central laboratory at screening * 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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