Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity
Primary Purpose
Obesity
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Semaglutide 2.4 mg
Placebo (semaglutide 2.4 mg)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- Age above or equal to 18 years at the time of signing informed consent.
- BMI at least 25.0 kg/m^2 at screening.
- Both parents of Asian descent.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
Exclusion Criteria:
- HbA1c at least 48 mmol/mol (6.5%) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
- A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records.
- Any participant where a substantial weight loss, in the investigator's opinion, might jeopardise the participant's safety.
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 15 mL/min/1.73 m^2 at screening.
Sites / Locations
- 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 SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Semaglutide 2.4 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in body weight
Percentage
At least 5% body weight reduction (yes/no)
Count of participant
Secondary Outcome Measures
At least 10% body weight reduction (yes/no)
Count of participant
At least 15% body weight reduction (yes/no)
Count of participant
Change in waist circumference
cm
At least 20% body weight reduction (yes/no)
Count of participant
Change in body weight
kg
Change in body mass index
kg/m^2
Change in systolic blood pressure
mmHg
Change in diastolic blood pressure
mmHg
Change in total cholesterol
mg/dL
Change in total cholesterol
mmol/L
Change in high-density lipoprotein (HDL) cholesterol
mg/dL
Change in high-density lipoprotein (HDL) cholesterol
mmol/L
Change in low-density lipoprotein (LDL) cholesterol
mg/dL
Change in low-density lipoprotein (LDL) cholesterol
mmol/L
Change in triglycerides
mg/dL
Change in triglycerides
mmol/L
Change in high-sensitivity c-reactive protein (hsCRP)
mg/L
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04998136
Brief Title
Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity
Official Title
Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Asians With Obesity Diagnosed as BMI ≥ 25 kg/m2 According to Local Guidelines
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
October 16, 2023 (Actual)
Study Completion Date
November 20, 2023 (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 looks at how well semaglutide helps people lose weight. This study will look at the change in the participants' body weight from the start to the end of the study. The study compares the weight loss in people who get semaglutide to the weight loss in people who get placebo. Placebo is a "dummy" medicine that looks like the study medicine, but has no effect on the body.
Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm.
Participants will also have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight.
The study will last for about a year (50 weeks). Participants will have 10 clinic visits and 8 phone calls. At 6 of the clinic visits participants will have blood samples taken. At 3 of the clinic visits participants cannot eat and drink (water is allowed) for 8 hours before the visit.
Participants cannot take part if participants have or have had diabetes. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
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
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Semaglutide 2.4 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Semaglutide 2.4 mg
Intervention Description
Administered subcutaneously (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 44 weeks. Doses gradually increased to 2.4 mg
Intervention Type
Drug
Intervention Name(s)
Placebo (semaglutide 2.4 mg)
Intervention Description
Administered s.c. as well as reduced-calorie diet and increased physical activity for 44 weeks
Primary Outcome Measure Information:
Title
Change in body weight
Description
Percentage
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
At least 5% body weight reduction (yes/no)
Description
Count of participant
Time Frame
From baseline (week 0) to end of treatment (week 44)
Secondary Outcome Measure Information:
Title
At least 10% body weight reduction (yes/no)
Description
Count of participant
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
At least 15% body weight reduction (yes/no)
Description
Count of participant
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in waist circumference
Description
cm
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
At least 20% body weight reduction (yes/no)
Description
Count of participant
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in body weight
Description
kg
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in body mass index
Description
kg/m^2
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in systolic blood pressure
Description
mmHg
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in diastolic blood pressure
Description
mmHg
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in total cholesterol
Description
mg/dL
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in total cholesterol
Description
mmol/L
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in high-density lipoprotein (HDL) cholesterol
Description
mg/dL
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in high-density lipoprotein (HDL) cholesterol
Description
mmol/L
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in low-density lipoprotein (LDL) cholesterol
Description
mg/dL
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in low-density lipoprotein (LDL) cholesterol
Description
mmol/L
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in triglycerides
Description
mg/dL
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in triglycerides
Description
mmol/L
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in high-sensitivity c-reactive protein (hsCRP)
Description
mg/L
Time Frame
From baseline (week 0) to end of treatment (week 44)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age above or equal to 18 years at the time of signing informed consent.
BMI at least 25.0 kg/m^2 at screening.
Both parents of Asian descent.
History of at least one self-reported unsuccessful dietary effort to lose body weight.
Exclusion Criteria:
HbA1c at least 48 mmol/mol (6.5%) as measured by the central laboratory at screening.
History of type 1 or type 2 diabetes mellitus.
A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records.
Any participant where a substantial weight loss, in the investigator's opinion, might jeopardise the participant's safety.
Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 15 mL/min/1.73 m^2 at screening.
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. 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Daejeon
ZIP/Postal Code
35365
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Gyeonggi-do
ZIP/Postal Code
10326
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Gyeonggi-Do
ZIP/Postal Code
14068
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Seongnam-si, Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
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
Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity
We'll reach out to this number within 24 hrs