Clinical trial NCT04998136: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-08-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.


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.

Primary outcomes:
measure: Change in Body Weight (%) : In-trial Observation Period
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in Body Weight (%) : On-treatment Observation Period
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period
timeFrame: At week 44
measure: Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period
timeFrame: At week 44
Secondary outcomes:
measure: Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no)
timeFrame: At week 44
measure: Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no)
timeFrame: At week 44
measure: Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no)
timeFrame: At week 44
measure: Change in Waist Circumference
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in Body Weight (kg)
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in Body Mass Index
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in Systolic Blood Pressure (mmHg)
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in Total Cholesterol (mg/dL) - Ratio to Baseline
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in Total Cholesterol (mmol/L) - Ratio to Baseline
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in Triglycerides (mg/dL) - Ratio to Baseline
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in Triglycerides (mmol/L) - Ratio to Baseline
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in High-sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in HbA1c (%)
timeFrame: Baseline (week 0), end of treatment (week 44)
measure: Change in HbA1c (mmol/Mol)
timeFrame: Baseline (week 0), end of treatment (week 44)
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Konyang university hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Gyeonggi-Do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital_Bangkok
city: Bangkok
country: Thailand
facility: Obstetrics&Gynecology King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Division of Nutrition and Biochemical Medicine
city: Bangkok
country: Thailand
facility: Siriraj Hospital_Bangkok_1
city: Bangkok
country: Thailand
facility: Siriraj Institute of Clinical Research
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: