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A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight (REDEFINE 6)

Primary Purpose

Obesity or Overweight

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Cagrilintide
Semaglutide
Placebo Semaglutide
Placebo Cagrilintide
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity or Overweight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

CagriSema

Semaglutide

Placebo

Arm Description

Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.

Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.

Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.

Outcomes

Primary Outcome Measures

CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
Measured in percentage (%)
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%
Measured as count of participants

Secondary Outcome Measures

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%
Measured as count of participants
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference
Measured in centimeter (cm)
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%
Measured as count of participants
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%
Measured as count of participants
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Change in waist circumference
Measured in centimeter (cm)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Glycated Haemoglobin (HbA1c)
Measured in percentage points
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Fasting Plasma Glucose (FPG)
Measured as millimole per liter (mmol/L)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in fasting serum insulin
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Systolic Blood Pressure (SBP)
Measured in millimeter of mercury (mmHg)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Diastolic Blood Pressure (DBP)
Measured in millimeter of mercury (mmHg)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in total cholesterol
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in high-density lipoprotein (HDL) cholesterol
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in low-density lipoprotein (LDL) cholesterol
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in very low-density lipoprotein (VLDL) cholesterol
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in triglycerides
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in free fatty acids
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Short Form-36 Version 2.0 (SF- 36v2) Physical Functioning score
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.
CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Physical Component Summary Score
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.
CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Mental Component Summary score
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.
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
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.
CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT Total score
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.
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Adverse Events (TEAEs)
Measured as count of events
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Serious Adverse Events (TESAEs)
Measured as count of events
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)
Measured as count of episodes
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)
Measured as count of episodes

Full Information

First Posted
August 10, 2023
Last Updated
September 4, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05996848
Brief Title
A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight
Acronym
REDEFINE 6
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 Chinese Participants With Overweight or Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
February 18, 2025 (Anticipated)
Study Completion Date
April 8, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity or Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CagriSema
Arm Type
Experimental
Arm Description
Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.
Arm Title
Semaglutide
Arm Type
Active Comparator
Arm Description
Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.
Intervention Type
Drug
Intervention Name(s)
Cagrilintide
Intervention Description
Participants will receive 2.4 mg cagrilintide subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Participants will receive 2.4 mg semaglutide subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo Semaglutide
Intervention Description
Participants will receive placebo matched to semaglutide subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo Cagrilintide
Intervention Description
Participants will receive placebo matched to cagrilintide subcutaneously.
Primary Outcome Measure Information:
Title
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
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%
Description
Measured as count of participants
Time Frame
From baseline (week 0) to end of treatment (week 44)
Secondary Outcome Measure Information:
Title
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%
Description
Measured as count of participants
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference
Description
Measured in centimeter (cm)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
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%
Description
Measured as count of participants
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
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%
Description
Measured as count of participants
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Change in waist circumference
Description
Measured in centimeter (cm)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Glycated Haemoglobin (HbA1c)
Description
Measured in percentage points
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Fasting Plasma Glucose (FPG)
Description
Measured as millimole per liter (mmol/L)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in fasting serum insulin
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Systolic Blood Pressure (SBP)
Description
Measured in millimeter of mercury (mmHg)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Diastolic Blood Pressure (DBP)
Description
Measured in millimeter of mercury (mmHg)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in total cholesterol
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in high-density lipoprotein (HDL) cholesterol
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in low-density lipoprotein (LDL) cholesterol
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in very low-density lipoprotein (VLDL) cholesterol
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in triglycerides
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in free fatty acids
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Short Form-36 Version 2.0 (SF- 36v2) Physical Functioning score
Description
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.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Physical Component Summary Score
Description
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.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Mental Component Summary score
Description
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.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
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
Description
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.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT Total score
Description
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.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Adverse Events (TEAEs)
Description
Measured as count of events
Time Frame
From baseline (week 0) to end of study (week 51)
Title
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Serious Adverse Events (TESAEs)
Description
Measured as count of events
Time Frame
From baseline (week 0) to end of study (week 51)
Title
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)
Description
Measured as count of episodes
Time Frame
From baseline (week 0) to end of study (week 51)
Title
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)
Description
Measured as count of episodes
Time Frame
From baseline (week 0) to end of study (week 51)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Office (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
ChongQing
State/Province
Chongqing
ZIP/Postal Code
404000
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
ChongQing
State/Province
Chongqing
ZIP/Postal Code
404000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Huizhou
State/Province
Guangdong
ZIP/Postal Code
516001
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Hengshui
State/Province
Hebei
ZIP/Postal Code
053000
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Kaifeng
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Kaifeng
State/Province
Henan
ZIP/Postal Code
475000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Changde
State/Province
Hunan
ZIP/Postal Code
415003
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215002
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221002
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221002
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Jin'an
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Jin'an
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200336
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200336
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201199
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201199
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201200
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Jingan/Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Jingan/Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

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

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