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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT04998136 (opens ClinicalTrials.gov in a new tab)Other idNN9536-4707Other idU1111-1265-5285
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
150 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
2 countries

South Korea, Thailand

Start
15 Aug 2022
Primary completion
16 Oct 2023
Completion
20 Nov 2023
First posted
10 Aug 2021
Last update posted
30 Dec 2025
Conditions
Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024
  1. Ph 3

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

    NCT04998136

    15 Aug 2022 to 20 Nov 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Semaglutide 2.4 mgDrug
  • Placebo (semaglutide 2.4 mg)Drug

Arms2

  • Experimental

    Semaglutide 2.4 mg

  • Placebo comparator

    Placebo

Primary outcomes4

Outcomes the sponsor listed as primary.

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

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

    Registry description

    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).

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

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

    Registry description

    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.

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

    Time frame · At week 44

    Registry description

    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).

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

    Time frame · At week 44

    Registry description

    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.

Secondary outcomes(19)

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

    Time frame · At week 44

    Registry description

    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).

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

    Time frame · At week 44

    Registry description

    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).

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

    Time frame · At week 44

    Registry description

    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).

  4. Change in Waist Circumference

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

    Registry description

    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).

  5. Change in Body Weight (kg)

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

    Registry description

    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).

  6. Change in Body Mass Index

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

    Registry description

    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).

  7. Change in Systolic Blood Pressure (mmHg)

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

    Registry description

    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).

  8. Change in Diastolic Blood Pressure

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

    Registry description

    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).

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

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

    Registry description

    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).

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

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

    Registry description

    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).

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

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

    Registry description

    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).

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

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

    Registry description

    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).

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

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

    Registry description

    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).

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

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

    Registry description

    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).

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

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

    Registry description

    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).

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

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

    Registry description

    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).

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

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

    Registry description

    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).

  18. Change in HbA1c (%)

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

    Registry description

    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).

  19. Change in HbA1c (mmol/Mol)

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

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (week 0), end of treatment (week 44)

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

GroupValue (Percentage of body weight)Spread
Semaglutide-16.47.3
Placebo-2.65.8
Primary outcomeMean· Baseline (week 0), end of treatment (week 44)

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

GroupValue (Percentage of body weight)Spread
Semaglutide-16.47.4
Placebo-2.75.8
Primary outcomeCount of participants· At week 44

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

GroupValue (Participants)
Semaglutide96
Placebo12
Primary outcomeCount of participants· At week 44

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

GroupValue (Participants)
Semaglutide92
Placebo12
Secondary and other outcome results(4)
Secondary outcomeCount of participants· At week 44

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

GroupValue (Participants)
Semaglutide78
Placebo5
Secondary outcomeCount of participants· At week 44

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

GroupValue (Participants)
Semaglutide53
Placebo2
Secondary outcomeCount of participants· At week 44

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

GroupValue (Participants)
Semaglutide30
Placebo0
Secondary outcomeMean· Baseline (week 0), end of treatment (week 44)

Change in Waist Circumference

GroupValue (Centimeter (cm))Spread
Semaglutide-12.07.5
Placebo-3.05.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SemaglutideParticipants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.0 / 10113 / 10180 / 101
PlaceboParticipants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.0 / 494 / 4934 / 49

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

9 results

Once-weekly semaglutide 2·4 mg in an Asian population with obesity, defined as BMI ≥25 kg/m2, in South Korea and Thailand (STEP 11): a randomised, double-blind, placebo-controlled, phase 3 trial.

Lim et al. 2025The lancet. Diabetes & endocrinologycited by 14

PMID 40825340DOI 10.1016/s2213-8587(25)00164-0PUB-40825340

Full text at the publisher9 results
Publisher pageSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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