ObesityPhase 3NCT04998136

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

A Phase 3 study testing Semaglutide 2.4 mg in people with Obesity, run by Novo Nordisk A/S at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obesity
What is being tested?: Semaglutide 2.4 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 16 sitesin 2 countries
Study dates: 15 Aug 2022to 20 Nov 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

16 sites in 2 countries.

Country

City, postcode or hospital

16 sites in 2 countries

Thailand9 sites

King Chulalongkorn Memorial Hospital_Bangkok
Bangkok, 10330
King Chulalongkorn Memorial Hospital_Endocrinology
Bangkok, 10330
King Chulalongkorn Memorial Hospital_Obstetrics&Gynecology
Bangkok, 10330
Obstetrics&Gynecology King Chulalongkorn Memorial Hospital
Bangkok, 10330
Ramathibodi Hospital_Nutrition and Biochemical
Bangkok, 10400
Siriraj Hospital_Bangkok_1
Bangkok, 10700
Siriraj Hospital_Dept Cardio
Bangkok, 10700
Siriraj Institute of Clinical Research
Bangkok, 10700
Maharaj Nakorn Chiang Mai_Hematology and Oncology
Chiang Mai, 50200

Other trials in Thailand

South Korea7 sites

Konyang University Hospital
Daejeon, 35365
Dongguk University Ilsan Hospital_Gyeonggi-do
Gyeonggi-do, 10326
Hallym University Sacred Heart Hospital
Gyeonggi-do, 14068
Gachon University Gil Hospital
Incheon, 405-760
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
SMG-SNU Boramae Medical Center
Seoul, 07061
Ajou University Hospital
Suwon, 16499

Other trials in South Korea

About this study

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

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.

Conditions: Obesity
Being tested: Semaglutide 2.4 mg, Placebo (semaglutide 2.4 mg)
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04998136
Study group	Role	What they receive
Semaglutide 2.4 mg	Experimental	Not described Receives: Drug: Semaglutide 2.4 mg
Placebo	Placebo comparator	Not described Receives: Drug: Placebo (semaglutide 2.4 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At week 44

Secondary outcomes (19)

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline (week 0), end of treatment (week 44)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 202220 Nov 2023

First posted10 Aug 2021
Study start15 Aug 2022
Primary completion16 Oct 2023
Study completion20 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04998136
Sponsor's protocol ID: NN9536-4707
Other IDs: U1111-1265-5285
Status last verified: Dec 2025
First submitted: 4 Aug 2021
Last updated: 30 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

Lim S, Buranapin S, Bao X, Quiroga M, Park KH, Kang JH, Rinnov AR, Suwanagool A. 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. Lancet Diabetes Endocrinol. 2025 Oct;13(10):838-847. doi: 10.1016/S2213-8587(25)00164-0. Epub 2025 Aug 15.
PubMed 40825340

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04998136
Acronym / sponsor ID: NN9536-4707
Conditions: Obesity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 15 Aug 2022 (actual)
Primary completion: 16 Oct 2023 (actual)
Study completion: 20 Nov 2023 (actual)
First posted: 10 Aug 2021 (actual)
Results: Posted 3 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Semaglutide 2.4 mg	Experimental	Drug: Semaglutide 2.4 mg
Placebo	Placebo comparator	Drug: Placebo (semaglutide 2.4 mg)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Semaglutide 2.4 mgAdministered 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	Drug	Semaglutide 2.4 mg
Placebo (semaglutide 2.4 mg)Administered s.c. as well as reduced-calorie diet and increased physical activity for 44 weeks	Drug	Placebo

Primary outcome

Change in Body Weight (%) : In-trial Observation Period
Time frame: Baseline (week 0), end of treatment (week 44)
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).
Change in Body Weight (%) : On-treatment Observation Period
Time frame: Baseline (week 0), end of treatment (week 44)
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.
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
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).
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
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.

19 secondary outcomes

Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no)
Time frame: At week 44
Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no)
Time frame: At week 44
Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no)
Time frame: At week 44
Change in Waist Circumference
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Body Weight (kg)
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Body Mass Index
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Systolic Blood Pressure (mmHg)
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Diastolic Blood Pressure
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Total Cholesterol (mg/dL) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Total Cholesterol (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Triglycerides (mg/dL) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in Triglycerides (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in High-sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 44)
Change in HbA1c (%)
Time frame: Baseline (week 0), end of treatment (week 44)
Change in HbA1c (mmol/Mol)
Time frame: Baseline (week 0), end of treatment (week 44)

Results and safety

Results posted to the registry on 3 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Semaglutide	101	101
Placebo	49	49

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

Time frame: Baseline (week 0), end of treatment (week 44). Mean (Standard Deviation). Unit: Percentage of body weight

Measure	Semaglutide n = 100	Placebo n = 48
Value	-16.4 (7.3)	-2.6 (5.8)

Semaglutide vs Placebo: Treatment difference: -12.99 (95% CI -15.28 to -10.70), p <0.0001, ANCOVA

Population analysed: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.

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

Time frame: Baseline (week 0), end of treatment (week 44). Mean (Standard Deviation). Unit: Percentage of body weight

Measure	Semaglutide n = 96	Placebo n = 47
Value	-16.4 (7.4)	-2.7 (5.8)

Semaglutide vs Placebo: Treatment Difference: -13.40 (95% CI -15.70 to -11.11), p <0.0001, MMRM

Population analysed: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Semaglutide n = 100	Placebo n = 48
Yes	96	12
No	4	36

Semaglutide vs Placebo: Odds Ratio (OR): 88.87 (95% CI 21.96 to 359.61), p <0.0001, Regression, Logistic

Population analysed: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Semaglutide n = 96	Placebo n = 47
Yes	92	12
No	4	35

Semaglutide vs Placebo: Odds Ratio (OR): 253.47 (95% CI 38.41 to 1672.57), p <0.0001, Regression, Logistic

Population analysed: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: From (week 0) to (week 49).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Semaglutide	13 of 101 (12.9%)	80 of 101 (79.2%)	0 of 101
Placebo	4 of 49 (8.2%)	34 of 49 (69.4%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40825340Lim S, Buranapin S, Bao X, Quiroga M, Park KH, Kang JH, Rinnov AR, Suwanagool A. 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. Lancet Diabetes Endocrinol. 2025 Oct;13(10):838-847. doi: 10.1016/S2213-8587(25)00164-0. Epub 2025 Aug 15.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Transparency (dept. 1452) study director

Novo Nordisk A/S

16 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semaglutide 2.4 mg in people with Obesity, run by Novo Nordisk A/S at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Thailand, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Weight (%) : In-trial Observation Period (time frame: Baseline (week 0), end of treatment (week 44)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04998136, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.