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

NCT04998136 | Completed Phase 3 Results

• 2 other identifiers: NN9536-4707U1111-1265-5285
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 16

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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).

  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.

  At week 44

Secondary Outcomes (19)

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

  At week 44

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

  At week 44

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

  At week 44

• Change in Waist Circumference

  Baseline (week 0), end of treatment (week 44)

• Change in Body Weight (kg)

  Baseline (week 0), end of treatment (week 44)

Study Arms (2)

Semaglutide 2.4 mg

EXPERIMENTAL

Drug: Semaglutide 2.4 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo (semaglutide 2.4 mg)

Interventions

Placebo (semaglutide 2.4 mg) DRUG

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

Placebo

Semaglutide 2.4 mg 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

Semaglutide 2.4 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (16)

Konyang University Hospital

Daejeon, 35365, South Korea

Location

Dongguk University Ilsan Hospital_Gyeonggi-do

Gyeonggi-do, 10326, South Korea

Location

Hallym University Sacred Heart Hospital

Gyeonggi-do, 14068, South Korea

Location

Gachon University Gil Hospital

Incheon, 405-760, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

King Chulalongkorn Memorial Hospital_Bangkok

Bangkok, 10330, Thailand

Location

King Chulalongkorn Memorial Hospital_Endocrinology

Bangkok, 10330, Thailand

Location

King Chulalongkorn Memorial Hospital_Obstetrics&Gynecology

Bangkok, 10330, Thailand

Location

Obstetrics&Gynecology King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Ramathibodi Hospital_Nutrition and Biochemical

Bangkok, 10400, Thailand

Location

Siriraj Hospital_Bangkok_1

Bangkok, 10700, Thailand

Location

Siriraj Hospital_Dept Cardio

Bangkok, 10700, Thailand

Location

Siriraj Institute of Clinical Research

Bangkok, 10700, Thailand

Location

Maharaj Nakorn Chiang Mai_Hematology and Oncology

Chiang Mai, 50200, Thailand

Location

Related Publications (1)

• 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.

  PMID: 40825340 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 10, 2021
• Study Start: August 15, 2022
• Primary Completion: October 16, 2023
• Study Completion: November 20, 2023
• Last Updated: December 30, 2025
• Results First Posted: April 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

KR (7); TH (9)