A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

NCT05567796
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
3,400
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Lead sponsor
Novo Nordisk A/S
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Start date
2022-11-01
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Number of sites
256
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Summary
This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms. Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.
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Acronym
REDEFINE 1
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Short title
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
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Official title
Efficacy and Safety of Cagrilintide s.c. 2.4 Milligram (mg) in Combination With Semaglutide Subcutaneous (s.c). 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-10-19
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First posted
2022-10-05
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Registry last updated
2026-07-17
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Primary completion date
2024-10-30
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Start date
2022-11-01
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Participants
3,400
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Participant count basis
Estimated
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Planned participants
3,400
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Protocol amendments
3
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Number of sites
256
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Novo Nordisk A/S
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05567796
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05567796
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. CagriSema versus placebo: Relative change in body weight

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

    Measured in percentage (%)

  2. CagriSema versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction

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

    Measured as count of participants

  1. CagriSema versus placebo: Achievement of >= 20% weight reduction

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

    Measured as count of participant

  2. CagriSema versus placebo: Achievement of >= 25% weight reduction

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

    Measured as count of participant

  3. CagriSema versus placebo: Achievement of >= 30% weight reduction

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

    Measured as count of participant

  4. CagriSema versus cagrilintide and CagriSema versus semaglutide: Relative change in body weight

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

    Measured as percentage (%)

  5. CagriSema versus placebo: Relative change in body weight

    Timeframe: From baseline (week 0) to week 8

    Measured as percentage (%)

  6. CagriSema versus placebo: Relative change in body weight

    Timeframe: From baseline (week 0) to week 20

    Measured as percentage (%)

  7. CagriSema versus placebo: Change in waist circumference

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

    Measured in centimeters (cm)

  8. CagriSema versus placebo: Change in systolic blood pressure (SBP)

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

    Measured in millimeters of mercury (mmHg)

  9. CagriSema versus placebo: 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 as score points. IWQOL-Lite-CT version 3 is a 20-item 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.

  10. CagriSema versus placebo: Change in SF-v2 Health Survey Acute (SF-36 v2 Acute) Physical Functioning Score

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

    Measured as score points. The SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being.

  11. CagriSema versus placebo, semaglutide and cagrilintide: Change in body weight

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

    Measured in kilograms (kg)

  12. CagriSema versus placebo, semalutide and cagrilintide: Change in body mass index (BMI)

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

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

  13. CagriSema versus placebo, semaglutide and cagrilintide: Improvement in weight category

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

    Measured as count of participants. The categories are: BMI, underweight less than (\<) 18.5, normal weight 18.5 to \<25, overweight 25.0 to \<30, obesity class I 30 to \< 35, obesity class II 35 to \< 40, obesity class III \>40.

  14. CagriSema versus placebo: Change in Glycated Haemoglobin (HbA1c)

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

    Measured as percentage (%)

  15. CagriSema versus placebo: Change in HbA1c

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

    Measured as millimoles per mole (mmol/mol).

  16. CagriSema versus placebo: Change in Fasting Plasma Glucose (FPG) (mmol/L).

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

    Measured as millimoles per liter (mmol/L).

  17. CagriSema versus placebo: Change in FPG (mg/dL)

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

    Measured as milligrams per deciliter (mg/dL).

  18. CagriSema versus placebo: Ratio to baseline in fasting serum insulin

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

    Measured as ratio

  19. CagriSema versus placebo: Change in Diastolic Blood Pressure (DBP)

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

    Measured in mmHg

  20. CagriSema versus placebo: Ratio to baseline in total cholesterol

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

    Measured as ratio

  21. CagriSema versus placebo: Ratio to baseline in High-density lipoprotein (HDL) cholesterol

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

    Measured as ratio

  22. CagriSema versus placebo: Ratio to baseline in Low-density lipoprotein (LDL) cholesterol

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

    Measured as ratio

  23. CagriSema versus placebo: Ratio to baseline in Very low-density lipoprotein (VLDL) cholesterol

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

    Measured as ratio

  24. CagriSema versus placebo: Ratio to baseline in Triglycerides

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

    Measured as ratio

  25. CagriSema versus placebo: Ratio to baseline in Free fatty acids

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

    Measured as ratio

And 40 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Healthy volunteers
No

  • Male or female
  • Age above or equal to 18 years at the time of signing informed consent
  • Body mass index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m^2) or b) BMI greater than or equal to 27.0 kg/m^2 with the presence of at least one weight-related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

- Glycaemia related: a) Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening b) History of type 1 or type 2 diabetes mellitus

Sources for eligibility
clinicaltrials.gov

  • Univ of Alabama BirminghamBirmingham, United States
  • Velocity Clin Res Los AngelesLos Angeles, United States
  • Velocity Clin Res WstlkeLos Angeles, United States
  • Univ of Colorado at DenverAurora, United States
  • OptumCare Clinical Trials LLCGolden, United States
  • Northeast Research InstituteFleming Island, United States
  • South Broward Research LLCMiramar, United States
  • Clinical Neuroscience SolutionOrlando, United States
  • Florida Inst For Clin ResOrlando, United States
  • Florida Institute for Clinical researchOrlando, United States
  • Clinical Trial Res Assoc,IncPlantation, United States
  • Hope Clin Res & WellnessConyers, United States
  • East West Med Res InstHonolulu, United States
  • Great Lakes Clinical TrialsChicago, United States
  • Endeavor HealthSkokie, United States
  • Evanston Premier Hlthcr ResSkokie, United States
  • Midwest Inst For Clin ResIndianapolis, United States
  • Northern Pines Hlth Ctr, PCBuckley, United States
  • StudyMetrix Research LLCCity of Saint Peters, United States
  • Velocity Clinical Research BinghamtonBinghamton, United States
  • Comprehensive Weight Ctrl ProgNew York, United States
  • University of North CarolinaChapel Hill, United States
  • University of North CarolinaChapel Hill, United States
  • Medication Mgmnt, LLC_GrnsboroGreensboro, United States
  • PharmQuest Life Sciences LLCGreensboro, United States

And 231 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2020-005435-75
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (1)