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Completed

NCT Number: NCT05394519

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

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.

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Key information

Conditions

Overweight Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes Mellitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitätsklinik für Innere Medizin Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cagrilintide

Drug

Cagrilintide administered subcutaneously (s.c., under the skin) once-weekly

semaglutide

Drug

Semaglutide administered subcutaneously (s.c., under the skin) once-weekly

Placebo Cagrilintide

Drug

Placebo cagrilintide administered subcutaneously (s.c., under the skin) once-weekly

Placebo Semaglutide

Drug

Placebo semaglutide administered subcutaneously (s.c., under the skin) once-weekly

Primary outcomes

  1. Relative change in body weight

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

    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)

    Count of participant.

Secondary outcomes

  1. Achievement of ≥ 20% weight reduction

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

    Count of participant.

  2. Relative change in body weight

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

    Measured in %.

  3. Change in waist circumference

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

    Measured in centimeter (cm).

  4. Change in Glycated Haemoglobin (HbA1c)

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

    Measured in %-points.

  5. Change in Systolic Blood Pressure (SBP)

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

    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)

    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)

    Measured in score points.

  8. Change in body weight

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

    Measured in kilogram (kg).

  9. Change in body mass index (BMI)

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

    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)

    Count of participant.

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

    Time frame: At end of treatment (week 68)

    Count of participant.

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

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

    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)

    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)

    Measured in ratio.

  15. Change in Diastolic Blood Pressure (DBP)

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

    Measured in mmHg.

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

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

    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)

    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)

    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)

    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)

    Count of participant.

  21. Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Acute Physical Functioning score

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

    Count of participant.

  22. Change in IWQOL-Lite-CT Physical Function score

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

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

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

    Count of participant.

  24. Continuous glucose monitoring: Change in mean glucose (mmol/L)

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

    Measured in mmol/L.

  25. Continuous glucose monitoring: Change in mean glucose (mg/L)

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

    Measured in mg/L.

  26. CGM: Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL)

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

    Measured in %-points.

  27. CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)

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

    Measured in %-points.

  28. CGM: Change in time above high range (TAHR) >13.9 mmol/L (>250 mg/dL)

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

    Measured in %-points.

  29. CGM: Change in time in tight range (TITR) 3.9-7.8 mmol/L (71-140 mg/dL)

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

    Measured in %-points.

  30. CGM: Within-day glycaemic variability (% CV)

    Time frame: At end of treatment (week 68)

    Measured in %.

  31. Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame: From baseline (week 0) to end of study (week 75)

    Count of events.

  32. Number of Treatment Emergent Serious adverse events (TESAEs)

    Time frame: From baseline (week 0) to end of study (week 75)

    Count of events.

  33. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)

    Time frame: From baseline (week 0) to end of study (week 75)

    Count of episodes.

  34. Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

    Time frame: From baseline (week 0) to end of study (week 75)

    Count of episodes.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity and Type 2 Diabetes

Acronym: REDEFINE 2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 27, 2022
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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