Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity

Novo Nordisk A/S150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Obesity

Interventions

Semaglutide 2.4 mgDRUG

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

Placebo (semaglutide 2.4 mg)DRUG

Administered s.c. as well as reduced-calorie diet and increased physical activity for 44 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Konyang University Hospital

Daejeon, South Korea

Dongguk University Ilsan Hospital_Gyeonggi-do

Gyeonggi-do, South Korea

Hallym University Sacred Heart Hospital

Gyeonggi-do, South Korea

Gachon University Gil Hospital

Incheon, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

SMG-SNU Boramae Medical Center

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

King Chulalongkorn Memorial Hospital_Bangkok

Bangkok, Thailand

King Chulalongkorn Memorial Hospital_Endocrinology

Bangkok, Thailand

King Chulalongkorn Memorial Hospital_Obstetrics&Gynecology

Bangkok, Thailand

...and 6 more locations

Outcomes

Primary Outcomes

Change in Body Weight (%) : In-trial Observation Period

Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in Body Weight (%) : On-treatment Observation Period

Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: The time period where participants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses.

Time frame: Baseline (week 0), end of treatment (week 44)

Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period

Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: At week 44

Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period

Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: the time period where partici-pants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses.

Time frame: At week 44

Secondary Outcomes

Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no)

Number of participants who achieved body weight reduction more than or equal to 10 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: At week 44

Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no)

Number of participants who achieved body weight reduction more than or equal to 15 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: At week 44

Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no)

Number of participants who achieved body weight reduction more than or equal to 20 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: At week 44

Change in Waist Circumference

Change in waist circumference from baseline (week 0) to the end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Data from ClinicalTrials.gov

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Time frame: Baseline (week 0), end of treatment (week 44)

Change in Body Weight (kg)

Change in body weight in kilogram (kg) is presented from baseline (week 0) to the end of treatment (week 44) and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in Body Mass Index

Change in body mass index from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in Systolic Blood Pressure (mmHg)

Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in Diastolic Blood Pressure

Change in diastolic blood pressure from baseline (week 0) to end of the treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in Total Cholesterol (mg/dL) - Ratio to Baseline

Change in total cholesterol in milligram per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in Total Cholesterol (mmol/L) - Ratio to Baseline

Change in total cholesterol in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline

Change in HDL cholesterol in mg/dL from (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline

Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline

Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline

Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in Triglycerides (mg/dL) - Ratio to Baseline

Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in Triglycerides (mmol/L) - Ratio to Baseline

Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in High-sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline

Change in hsCRP in milligram per liter (mg/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in HbA1c (%)

Change in glycosylated haemoglobin (HbA1c) in percentage from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)

Change in HbA1c (mmol/Mol)

Change in glycosylated heamoglobin (HbA1c) in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Time frame: Baseline (week 0), end of treatment (week 44)