Phase 3 · Semaglutide

NCT04998136 trial results

Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Asians With Obesity Diagnosed as BMI ≥ 25 kg/m2 According to Local Guidelines

Change in Body Weight (%) : In-trial Observation Period (Percentage of body weight), Baseline (week 0), end of treatment (week 44). Semaglutide: -16.4; Placebo: -2.6.

Participants: 150
Status: completed
Completed: 2023-11-20
Sponsor: Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT04998136), updated at source Dec 30, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT04998136 measured first

Change in Body Weight (%) : In-trial Observation PeriodPercentage of body weight · Baseline (week 0), end of treatment (week 44) · mean

Semaglutiden=100	Placebon=48
-16.4(7.3)	-2.6(5.8)

Change in Body Weight (%) : On-treatment Observation PeriodPercentage of body weight · Baseline (week 0), end of treatment (week 44) · mean

Semaglutiden=96	Placebon=47
-16.4(7.4)	-2.7(5.8)

Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation PeriodParticipants · At week 44 · count of participants

Measure	Semaglutiden=100	Placebon=48
Yes	96	12
No	4	36

Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation PeriodParticipants · At week 44 · count of participants

Measure	Semaglutiden=96	Placebon=47
Yes	92	12
No	4	35

Side effects by arm

Side effects in NCT04998136

Percent of participants affected, From (week 0) to (week 49).. The most common events the registry lists.

Event	Semaglutide	Placebo
Any serious event	12.9%	8.2%
Nausea	37.6%	14.3%
COVID-19	14.9%	32.7%
Diarrhoea	27.7%	6.1%
Nasopharyngitis	11.9%	24.5%
Constipation	21.8%	16.3%
Upper respiratory tract infection	7.9%	14.3%
Decreased appetite	12.9%	4.1%
Headache	12.9%	6.1%
Dyspepsia	11.9%	10.2%
Dizziness	10.9%	6.1%
Vomiting	10.9%	4.1%
Arthralgia	4%	10.2%
Alopecia	6.9%	0%
Gastroenteritis	5%	6.1%

Secondary outcomes

What else it measured

Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no)Participants · At week 44 · count of participants

Measure	Semaglutiden=100	Placebon=48
Yes	78	5
No	22	43

Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no)Participants · At week 44 · count of participants

Measure	Semaglutiden=100	Placebon=48
Yes	53	2
No	47	46

Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no)Participants · At week 44 · count of participants

Measure	Semaglutiden=100	Placebon=48
Yes	30	0
No	70	48

Change in Waist CircumferenceCentimeter (cm) · Baseline (week 0), end of treatment (week 44) · mean

Semaglutiden=100	Placebon=48
-12.0(7.5)	-3.0(5.4)

Change in Body Weight (kg)Kg · Baseline (week 0), end of treatment (week 44) · mean

Semaglutiden=100	Placebon=48
-13.0(5.5)	-2.0(5.1)

Change in Body Mass IndexKilogram per square meter (kg/m^2) · Baseline (week 0), end of treatment (week 44) · mean

Semaglutiden=100	Placebon=48
-4.9(2.1)	-0.8(1.9)

Change in Systolic Blood Pressure (mmHg)Millimeter of mercury (mmHg) · Baseline (week 0), end of treatment (week 44) · mean

Semaglutiden=100	Placebon=48
-11(14)	-1(13)

Change in Diastolic Blood PressureMmHg · Baseline (week 0), end of treatment (week 44) · mean

Semaglutiden=100	Placebon=48
-4(11)	0(12)

Change in Total Cholesterol (mg/dL) - Ratio to BaselineRatio of total cholesterol · Baseline (week 0), end of treatment (week 44) · geometric mean

Semaglutiden=100	Placebon=48
0.91(15.7)	1.03(12.3)

Change in Total Cholesterol (mmol/L) - Ratio to BaselineRatio of total cholesterol · Baseline (week 0), end of treatment (week 44) · geometric mean

Semaglutiden=100	Placebon=48
0.91(15.7)	1.03(12.3)

Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to BaselineRatio of HDL cholesterol · Baseline (week 0), end of treatment (week 44) · geometric mean

Semaglutiden=99	Placebon=48
1.00(15.3)	1.04(13.7)

Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to BaselineRatio of HDL cholesterol · Baseline (week 0), end of treatment (week 44) · geometric mean

Semaglutiden=99	Placebon=48
1.00(15.3)	1.04(13.7)

The trial

How NCT04998136 was run

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.

Semaglutide 2.4 mg
Placebo

Who could join the trial

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.

Published papers

Papers from NCT04998136

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.

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.