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Completed

NCT Number: NCT05996848

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

This study will look at how well the new medicine CagriSema helps people with excess body weight losing weight compared to a "dummy" medicine and a medicine called semaglutide. Participants will either get CagriSema, a dummy medicine or semaglutide. Which treatment participants get is decided by chance. Participants will take one injection once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1 year.

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Key information

Conditions

Obesity or Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chinese People's Liberation Army General Hospital-Endocrinology, Beijing, Beijing Municipality, China

Loading trial locations.

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
  • Body Mass Index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m^2) or
  • 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, type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

For participants with Type 2 diabetes (T2D) at screening the following criteria also apply:

  • Diagnosed with type 2 diabetes mellitus greater than equal to 180 days before screening
  • Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i)), thiazolidinediones, or sulphonylureas (SUs) 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 60 days before screening
  • Glycated Haemoglobin (HbA1c) 7 percent-10 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by the central laboratory at screening

Exclusion criteria

For participants without T2D at screening:

  • HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
  • History of type 1 or type 2 diabetes mellitus

For participants with T2D 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) lesser than 30 milli liter per min/1.73 meter square (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

Participants will receive 2.4 mg cagrilintide subcutaneously.

semaglutide

Drug

Participants will receive 2.4 mg semaglutide subcutaneously.

Placebo Semaglutide

Drug

Participants will receive placebo matched to semaglutide subcutaneously.

Placebo Cagrilintide

Drug

Participants will receive placebo matched to cagrilintide subcutaneously.

Primary outcomes

  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 44)

    Measured in percentage (%)

  2. CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 5%

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured as count of participants

Secondary outcomes

  1. CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 20%

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured as count of participants

  2. 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 44)

    Measured in percentage (%)

  3. CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured in centimeter (cm)

  4. CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 10%

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured as count of participants

  5. CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 15%

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured as count of participants

  6. CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Change in waist circumference

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured in centimeter (cm)

  7. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Glycated Haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured in percentage points

  8. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Fasting Plasma Glucose (FPG)

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured as millimole per liter (mmol/L)

  9. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in fasting serum insulin

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured in percentage (%)

  10. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Systolic Blood Pressure (SBP)

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured in millimeter of mercury (mmHg)

  11. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Diastolic Blood Pressure (DBP)

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured in millimeter of mercury (mmHg)

  12. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in total cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured in percentage (%)

  13. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in high-density lipoprotein (HDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured in percentage (%)

  14. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in low-density lipoprotein (LDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured in percentage (%)

  15. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in very low-density lipoprotein (VLDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured in percentage (%)

  16. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in triglycerides

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured in percentage (%)

  17. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in free fatty acids

    Time frame: From baseline (week 0) to end of treatment (week 44)

    Measured in percentage (%)

  18. 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 44)

    Measured as score points. The SF-36v2.0 is a 36-item commonly used generic clinical outcome assessment (COA) instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'physical functioning domain'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 correspond to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.

  19. CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Physical Component Summary Score

    Time frame: From baseline (week 0) to end of treatment (week 44)

    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. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'physical component summary'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.

  20. CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Mental Component Summary score

    Time frame: From baseline (week 0) to end of treatment (week 44)

    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. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'mental component summary'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.

  21. CagriSema 2.4 mg/2.4 mg versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOLLite- CT) Physical Function score

    Time frame: From baseline (week 0) to end of treatment (week 44)

    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 patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. This endpoint assess the 'physical function score'. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline.

  22. 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 44)

    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 patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. This endpoint assess the 'total score'. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline.

  23. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame: From baseline (week 0) to end of study (week 51)

    Measured as count of events

  24. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Serious Adverse Events (TESAEs)

    Time frame: From baseline (week 0) to end of study (week 51)

    Measured as count of events

  25. Number of clinically significant hypoglycaemic episodes (level 2) (lesser than 3.0 mmol/L (54 milligrams per deciliter[mg/dL]), confirmed by BG meter) (only for participants with Type 2 diabetes (T2D) at screening)

    Time frame: From baseline (week 0) to end of study (week 51)

    Measured as count of episodes

  26. Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold (only for participants with T2D at screening)

    Time frame: From baseline (week 0) to end of study (week 51)

    Measured as 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 Chinese Participants With Overweight or Obesity

Acronym: REDEFINE 6

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 18, 2023
Registry last updated
Jan 9, 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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