A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
- Summary
- 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.
- Acronym
- REDEFINE 2
- Short title
- A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
- Official 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2025-02-03
- First posted
- 2022-05-27
- Registry last updated
- 2026-01-28
- Primary completion date
- 2025-01-28
- Start date
- 2023-02-01
- Actual participants
- 1,200
- Participants
- 1,200
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Novo Nordisk A/S
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05394519
- ClinicalTrials.gov ID
- NCT05394519
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Relative change in body weight
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%).
Achievement of greater than or equal to (≥) 5% weight reduction
Timeframe: From baseline (week 0) to end of treatment (week 68)
Count of participant.
Achievement of ≥ 20% weight reduction
Timeframe: From baseline (week 0) to end of treatment (week 68)
Count of participant.
Relative change in body weight
Timeframe: From baseline (week 0) to week 20
Measured in %.
Change in waist circumference
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in centimeter (cm).
Change in Glycated Haemoglobin (HbA1c)
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in %-points.
Change in Systolic Blood Pressure (SBP)
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in millimeter of mercury (mmHg).
Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in score points.
Change in Short Form-36 Version 2.0 Health Survey Acute (SF-36v2 Acute) Physical Functioning score
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in score points.
Change in body weight
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in kilogram (kg).
Change in body mass index (BMI)
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in kilogram per meter square (kg/m\^2).
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)
Timeframe: From baseline (week 0) to end of treatment (week 68)
Count of participant.
Achievement of HbA1c less than or equal to (≤) 6.5%
Timeframe: At end of treatment (week 68)
Count of participant.
Change in Fasting Plasma Glucose (mmol/L)
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in millimoles per liter (mmol/L).
Change in Fasting Plasma Glucose (mg/dL)
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in milligram per deciliter (mg/dL)
Ratio to baseline in fasting serum insulin
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Change in Diastolic Blood Pressure (DBP)
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in mmHg.
Ratio to baseline in C-reactive protein (CRP)
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
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
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Change in IWQOL-Lite-CT: Total score, Physical and Psycosocial score
Timeframe: 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.
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
Timeframe: 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.
Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score
Timeframe: From baseline (week 0) to end of treatment (week 68)
Count of participant.
Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Acute Physical Functioning score
Timeframe: From baseline (week 0) to end of treatment (week 68)
Count of participant.
Change in IWQOL-Lite-CT Physical Function score
Timeframe: From baseline (week 0) to end of treatment (week 68)
Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite -CT Physical Function score for subgroup
Timeframe: From baseline (week 0) to end of treatment (week 68)
Count of participant.
Continuous glucose monitoring: Change in mean glucose (mmol/L)
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in mmol/L.
Continuous glucose monitoring: Change in mean glucose (mg/L)
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in mg/L.
And 9 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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
- 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.
- John Muir Physicians NetworkConcord, United States
- Headlands Research California, LLCEscondido, United States
- Providence Medical FoundationFullerton, United States
- St. Jos Heritage Hlthcr_FllrtnFullerton, United States
- Diabetes/Lipid Mgmt & Res CtrHuntington Beach, United States
- Clinical Trials ResearchLincoln, United States
- Velocity Clin Res Los AngelesLos Angeles, United States
- Velocity Clin Res WstlkeLos Angeles, United States
- Desert Oasis Hlthcr Med GroupPalm Springs, United States
- Diablo Clinical Research, Inc.Walnut Creek, United States
- New West Physicians,Inc.Golden, United States
- Clinical Res Of W Florida IncClearwater, United States
- Northeast Research InstituteFleming Island, United States
- Jacksonville Ctr For Clin ResJacksonville, United States
- Renstar Medical ResearchOcala, United States
- AdventHealth Diab InstOrlando, United States
- Florida Institute for Clinical Research, LLCOrlando, United States
- Oviedo Medical Research, LLCOviedo, United States
- Endo Res Solutions IncRoswell, United States
- East West Med Res InstHonolulu, United States
- Cedar-Crosse Research CenterChicago, United States
- Iowa Diab & Endo Res CenterWest Des Moines, United States
- Cotton-Oneill Diabetes and EndTopeka, United States
- L-MARC Research CenterLouisville, United States
- Pennington Biom Res CtrBaton Rouge, United States
And 154 more, listed on the interactive page.
- PubMed 40544432Related publication
- jRCT2031220671
- 2021-005121-24
- U1111-1267-4287