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A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (REDEFINE 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05567796
Recruitment Status : Recruiting
First Posted : October 5, 2022
Last Update Posted : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Obesity Drug: Cagrilintide Drug: Semaglutide Drug: Placebo cagrilintide Drug: Placebo semaglutide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2022
Estimated Primary Completion Date : January 19, 2025
Estimated Study Completion Date : October 19, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cagrisema s.c. 2.4 mg/2.4 mg
Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide once-weekly after a dose escalation period of 16 weeks (0.25 mg of cagrilintide and 0.25 mg of semaglutide from weeks 0-4, 0.5 mg of cagrilintide and 0.5 mg of semaglutide from weeks 5-8, 1 mg of cagrilintide and 1 mg of semaglutide from weeks 9-12 and 1.7 mg of cagrilintide and 1.7 mg of semaglutide from weeks 13-16) during the maintenance period for 52 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for 97 weeks.
 Drug: Cagrilintide
Cagrilintide will be administered subcutaneously.

Drug: Semaglutide
Participants will recieve semaglutide subcutaneously.
Active Comparator: Cagrilintide s.c. 2.4 mg
Participants will receive cagrilintide s.c. 2.4 mg and placebo matching to semaglutide once-weekly after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks.
 Drug: Cagrilintide
Cagrilintide will be administered subcutaneously.

Drug: Placebo semaglutide
Participants will receive placebo matched to semaglutide.
Active Comparator: Semaglutide s.c. 2.4 mg
Participants will receive semaglutide s.c. 2.4 mg and placebo matched to cagrilintide once-weekly after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks.
 Drug: Semaglutide
Participants will recieve semaglutide subcutaneously.

Drug: Placebo cagrilintide
Participants will receive placebo matched to cagrilintide.
Placebo Comparator: Placebo s.c.
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeks. Participants randomised to this arm will be included in the extension phase for 97 weeks.
 Drug: Placebo cagrilintide
Participants will receive placebo matched to cagrilintide.

Drug: Placebo semaglutide
Participants will receive placebo matched to semaglutide.


Outcome Measures
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Primary Outcome Measures :
  1. CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in percentage (%)

  2. CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as count of participants


Secondary Outcome Measures :
  1. CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 20% weight reduction [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as count of participant

  2. CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 25% weight reduction [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as count of participant

  3. CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 30% weight reduction [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as count of participant

  4. CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg; and CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as percentage (%)

  5. CagriSema 0.5 mg/0.5 mg versus placebo: Relative change in body weight [ Time Frame: From baseline (week 0) to week 8 ]
    Measured as percentage (%)

  6. CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight [ Time Frame: From baseline (week 0) to week 20 ]
    Measured as percentage (%)

  7. CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in centimeters (cm)

  8. CagriSema 2.4 mg/2.4 mg versus placebo: Change in systolic blood pressure (SBP) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in millimeters of mercury (mmHg)

  9. CagriSema 2.4 mg/2.4 mg versus placebo: Change in 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 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 2.4 mg/2.4 mg versus placebo: Change in Short Form-36 Version 2.0 (SF-36v2) Physical Functioning Score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as score points. The SF-36v2.0 is a 36-item commonly used generic COA instrument measuring health related quality of life and general health status across disease areas. The SF-36v2.0 for adults with a 1 week recall period (i.e. acute version) measures the individual overall health-related quality of life in 8 health domains (physical functioning, role-physical, bodily pain, general health, social functioning, role-emotional, vitality and mental health). Furthermore, it includes two aggregated scores: a physical component summary score and a mental component summary score.

  11. CagriSema 2.4 mg/2.4 mg versus placebo: Change in Glycated Haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as percentage (%)

  12. CagriSema 2.4 mg/2.4 mg versus placebo: Change in Fasting Plasma Glucose (FPG) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as millimoles per liter (mmol/L)

  13. CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in fasting serum insulin [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as percentage (%)

  14. CagriSema 2.4 mg/2.4 mg versus placebo: Change in Diastolic Blood Pressure (DBP) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in mmHg

  15. CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in total cholesterol [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as percentage (%)

  16. CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in High-density lipoprotein (HDL) cholesterol [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as percentage (%).

  17. CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in Low-density lipoprotein (LDL) cholesterol [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as percentage (%)

  18. CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in Very low-density lipoprotein (VLDL) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as percentage (%)

  19. CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in Triglycerides [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as percentage (%)

  20. CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in Free fatty acids [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as percentage (%)

  21. 'CagriSema 2.4 mg/2.4 mg versus placebo: Change in total fat mass by Dual energy Xray absorption (DXA) relative to total body mass [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in percentage (%)

  22. CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in visceral fat mass by DXA [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as percentage (%)

  23. CagriSema 2.4 mg/2.4 mg versus placebo: Change in lean body mass by DXA relative to total body mass [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured in percentage (%)

  24. CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Physical Component Summary Score and Mental Component Summary Score [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
    Measured as score points. The SF-36v2.0 is a 36-item commonly used generic COA instrument measuring health related quality of life and general health status across disease areas. The SF-36v2.0 for adults with a 1 week recall period (i.e. acute version) measures the individual overall health-related quality of life in 8 health domains (physical functioning, role-physical, bodily pain, general health, social functioning, role-emotional, vitality and mental health). Furthermore, it includes two aggregated scores: a physical component summary score and a mental component summary score.

  25. CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT Total score [ Time Frame: 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.

  26. Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From baseline (week 0) to end of study-main part (week 75) ]
    Measured as count of events

  27. Number of Treatment Emergent Serious adverse events (TESAEs) [ Time Frame: From baseline (week 0) to end of study-main part (week 75) ]
    Measured as count of events.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

- 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05567796


Contacts
Layout table for location contacts
Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Office dept. 2834 Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT05567796    
Other Study ID Numbers: NN9838-4608
Universal Trial Number (UTN) ( Other Identifier: U1111-1261-1912 )
2020-005435-75 ( EudraCT Number )
First Posted: October 5, 2022    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight