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

NCT ID: NCT04998136

Last Updated: 2025-12-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-11-20

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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Semaglutide 2.4 mg

Group Type EXPERIMENTAL

Semaglutide 2.4 mg

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo (semaglutide 2.4 mg)

Intervention Type DRUG

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

Interventions

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Semaglutide 2.4 mg

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

Placebo (semaglutide 2.4 mg)

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Konyang University Hospital

Daejeon, , South Korea

Site Status

Dongguk University Ilsan Hospital_Gyeonggi-do

Gyeonggi-do, , South Korea

Site Status

Hallym University Sacred Heart Hospital

Gyeonggi-do, , South Korea

Site Status

Gachon University Gil Hospital

Incheon, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, , South Korea

Site Status

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

Ajou University Hospital

Suwon, , South Korea

Site Status

King Chulalongkorn Memorial Hospital_Bangkok

Bangkok, , Thailand

Site Status

King Chulalongkorn Memorial Hospital_Endocrinology

Bangkok, , Thailand

Site Status

King Chulalongkorn Memorial Hospital_Obstetrics&Gynecology

Bangkok, , Thailand

Site Status

Obstetrics&Gynecology King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status

Ramathibodi Hospital_Nutrition and Biochemical

Bangkok, , Thailand

Site Status

Siriraj Hospital_Bangkok_1

Bangkok, , Thailand

Site Status

Siriraj Hospital_Dept Cardio

Bangkok, , Thailand

Site Status

Siriraj Institute of Clinical Research

Bangkok, , Thailand

Site Status

Maharaj Nakorn Chiang Mai_Hematology and Oncology

Chiang Mai, , Thailand

Site Status

Countries

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South Korea Thailand

References

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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.

Reference Type DERIVED
PMID: 40825340 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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U1111-1265-5285

Identifier Type: OTHER

Identifier Source: secondary_id

NN9536-4707

Identifier Type: -

Identifier Source: org_study_id