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

Primary Purpose

Obesity or Overweight

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cagrilintide
Semaglutide
Placebo Semaglutide
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 greater than to or equal 18 years at the time of signing informed consent a) Body mass index (BMI) greater than or equal to 27.0 kilograms per square meter (kg/m^2) with greater than or equal to 2 obesity-related complications or b) BMI greater than or equal to 35.0 kg/m^2 with greater than or equal to 1 obesity-related complication. At least one complication should be hypertension, dyslipidaemia or T2D Diabetes-related for participant with T2D Diagnosed with T2D greater than or equal to 180 days before screening HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at 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 cotransporter 2 inhibitor [SGLT2i]), thiazolidinediones, or sulphonylureas [SU] 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 Exclusion Criteria: Obesity-related - Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening Glycaemia-related for participant without T2D 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 Diabetes-related for participant with T2D 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 central laboratory at screening Clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness 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 SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CagriSema 2.4 mg/2.4 mg

Semaglutide 2.4 mg

Arm Description

Participants will receive 2.4 milligrams (mg) cagrilintide and 2.4 mg semaglutide subcutaneously (s.c.) once-weekly (OW) 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

Participants will receive semaglutide s.c. 2.4 mg and placebo matched to semaglutide OW 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

Outcomes

Primary Outcome Measures

Relative Change in Body Weight
Measured in percentage (%)

Secondary Outcome Measures

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent
Measured as count of participants
Change in Waist Circumference Measured According to Japan Society for the Study of Obesity (JASSO) Guideline
Measured in centimeter (cm)
Change in Visceral Fat Area (VFA) Measured by CT Scan in Subset of the Japanese Study Population
Measured as percentage point
Change in VFA Measured by CT Scan in Subset of the Japanese Study Population
Measured in centimeter square (cm^2)
Number of Participants Who Achieve (Yes/No): VFA lesser than 100 cm^2 (Only for Participants with VFA greater than or equal to 100 cm^2 at Baseline)
Measured as count of participants
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 25 Percent
Measured as count of participants
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent
Measured as count of participants
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent
Measured as count of participants
Relative Change in Body Weight
Measured in percentage (%)
Change in Body Weight
Measured in kilogram (kg)
Change in Body Mass Index (BMI)
Measured in kilogram per meter square (kg/m^2)
Change in Glycated Haemoglobin (HbA1c)
Measured in percentage points
Change in Fasting Plasma Glucose (FPG)
Measured as millimole per liter (mmol/L)
Change in Fasting Insulin
Measured as milliunits per liter (mU/L)
Change in Systolic Blood Pressure (SBP)
Measured in millimeter of mercury (mmHg)
Change in Diastolic Blood Pressure (DBP)
Measured in millimeter of mercury (mmHg)
Change in Total Cholesterol
Measured in percentage (%)
Change in High-Density Lipoprotein (HDL) Cholesterol
Measured in percentage (%)
Change in Low-Density Lipoprotein (LDL) Cholesterol
Measured in percentage (%)
Change in Very Low-Density Lipoprotein (VLDL)
Measured in percentage (%)
Change in Triglycerides
Measured in percentage (%)
Change in Free fatty Acids
Measured in percentage (%)
Change in Impact of Weight on Quality of Life-Lite for clinical trials (IWQOL-Lite-CT) Physical Function Score
IWQOL-Lite-CT is a 20-item patient reported outcome (PRO) 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
Number of Treatment-Emergent Adverse Events (TEAEs)
Measured as count of events
Number of Serious Adverse Events (SAEs)
Measured as count of events

Full Information

First Posted
April 3, 2023
Last Updated
September 25, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05813925
Brief Title
A Research Study to See How Well CagriSema Helps People in East Asia With 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 East Asian Participants With Overweight or Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
January 27, 2025 (Anticipated)
Study Completion Date
March 17, 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 lose weight compared to another medicine, semaglutide. The participants will receive one injection once a week. The study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1½ years.

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CagriSema 2.4 mg/2.4 mg
Arm Type
Experimental
Arm Description
Participants will receive 2.4 milligrams (mg) cagrilintide and 2.4 mg semaglutide subcutaneously (s.c.) once-weekly (OW) 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
Arm Title
Semaglutide 2.4 mg
Arm Type
Active Comparator
Arm Description
Participants will receive semaglutide s.c. 2.4 mg and placebo matched to semaglutide OW 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
Intervention Type
Drug
Intervention Name(s)
Cagrilintide
Intervention Description
Participants will receive 2.4 mg cagrilintide s.c. OW after a dose escalation period of 16 weeks for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Participants will receive 2.4 mg semaglutide s.c. OW after a dose escalation period of 16 weeks for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo Semaglutide
Intervention Description
Participants will receive placebo matched to semaglutide
Primary Outcome Measure Information:
Title
Relative Change in Body Weight
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 68)
Secondary Outcome Measure Information:
Title
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent
Description
Measured as count of participants
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in Waist Circumference Measured According to Japan Society for the Study of Obesity (JASSO) Guideline
Description
Measured in centimeter (cm)
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in Visceral Fat Area (VFA) Measured by CT Scan in Subset of the Japanese Study Population
Description
Measured as percentage point
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in VFA Measured by CT Scan in Subset of the Japanese Study Population
Description
Measured in centimeter square (cm^2)
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Number of Participants Who Achieve (Yes/No): VFA lesser than 100 cm^2 (Only for Participants with VFA greater than or equal to 100 cm^2 at Baseline)
Description
Measured as count of participants
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 25 Percent
Description
Measured as count of participants
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent
Description
Measured as count of participants
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent
Description
Measured as count of participants
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Relative Change in Body Weight
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to week 20
Title
Change in Body Weight
Description
Measured in kilogram (kg)
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in Body Mass Index (BMI)
Description
Measured in kilogram per meter square (kg/m^2)
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in Glycated Haemoglobin (HbA1c)
Description
Measured in percentage points
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
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 68)
Title
Change in Fasting Insulin
Description
Measured as milliunits per liter (mU/L)
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in Systolic Blood Pressure (SBP)
Description
Measured in millimeter of mercury (mmHg)
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in Diastolic Blood Pressure (DBP)
Description
Measured in millimeter of mercury (mmHg)
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in Total Cholesterol
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in High-Density Lipoprotein (HDL) Cholesterol
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in Low-Density Lipoprotein (LDL) Cholesterol
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in Very Low-Density Lipoprotein (VLDL)
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in Triglycerides
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in Free fatty Acids
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Change in Impact of Weight on Quality of Life-Lite for clinical trials (IWQOL-Lite-CT) Physical Function Score
Description
IWQOL-Lite-CT is a 20-item patient reported outcome (PRO) 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
Time Frame
From baseline (week 0) to end of treatment (week 68)
Title
Number of Treatment-Emergent Adverse Events (TEAEs)
Description
Measured as count of events
Time Frame
From baseline (week 0) to end of study (week 75)
Title
Number of Serious Adverse Events (SAEs)
Description
Measured as count of events
Time Frame
From baseline (week 0) to end of study (week 75)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female Age greater than to or equal 18 years at the time of signing informed consent a) Body mass index (BMI) greater than or equal to 27.0 kilograms per square meter (kg/m^2) with greater than or equal to 2 obesity-related complications or b) BMI greater than or equal to 35.0 kg/m^2 with greater than or equal to 1 obesity-related complication. At least one complication should be hypertension, dyslipidaemia or T2D Diabetes-related for participant with T2D Diagnosed with T2D greater than or equal to 180 days before screening HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at 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 cotransporter 2 inhibitor [SGLT2i]), thiazolidinediones, or sulphonylureas [SU] 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 Exclusion Criteria: Obesity-related - Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening Glycaemia-related for participant without T2D 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 Diabetes-related for participant with T2D 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 central laboratory at screening Clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness 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 Transparency' (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Koriyama-shi
State/Province
Fukushima, Japan
ZIP/Postal Code
963-8851
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Yamato-shi
State/Province
Kanagawa
ZIP/Postal Code
242-0004
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Miyazaki-shi
State/Province
Miyazaki, Japan
ZIP/Postal Code
880-0034
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Yao-shi
State/Province
Osaka
ZIP/Postal Code
581-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Aichi
ZIP/Postal Code
468-0009
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bunkyo-ku, Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Chiba-shi, Chiba
ZIP/Postal Code
260-0804
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Chiyoda-ku, Tokyo
ZIP/Postal Code
101-0065
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Chuo-ku, Tokyo
ZIP/Postal Code
103-0002
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Chuo-ku, Tokyo
ZIP/Postal Code
104-0061
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Gunma
ZIP/Postal Code
373-0036
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Ibaraki
ZIP/Postal Code
311-0113
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
004-0004
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Sendai-shi, Miyagi
ZIP/Postal Code
983-0039
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
160-0008
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
192-0918
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Taipei City
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Active, not 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 East Asia With Excess Body Weight Lose Weight

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