Phase 3
N=150
Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04998136 ↗Enrolled (actual)
150
Serious AEs
11.3%
Results posted
Apr 2025
Primary outcome: Primary: Change in Body Weight (%) : In-trial Observation Period — -16.4; -2.6 Percentage of body weight — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Semaglutide 2.4 mg (Drug); Placebo (semaglutide 2.4 mg) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight (%) : In-trial Observation Period |
-16.4; -2.6 | <0.0001 sig |
| PRIMARY Change in Body Weight (%) : On-treatment Observation Period |
-16.4; -2.7 | <0.0001 sig |
| PRIMARY Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period |
96; 12; 4; 36 | <0.0001 sig |
| PRIMARY Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period |
92; 12; 4; 35 | <0.0001 sig |
| SECONDARY Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no) |
78; 5; 22; 43 | — |
| SECONDARY Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no) |
53; 2; 47; 46 | — |
| SECONDARY Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no) |
30; 0; 70; 48 | — |
| SECONDARY Change in Waist Circumference |
-12.0; -3.0 | — |
| SECONDARY Change in Body Weight (kg) |
-13.0; -2.0 | — |
| SECONDARY Change in Body Mass Index |
-4.9; -0.8 | — |
| SECONDARY Change in Systolic Blood Pressure (mmHg) |
-11; -1 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-4; 0 | — |
| SECONDARY Change in Total Cholesterol (mg/dL) - Ratio to Baseline |
0.91; 1.03 | — |
| SECONDARY Change in Total Cholesterol (mmol/L) - Ratio to Baseline |
0.91; 1.03 | — |
| SECONDARY Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline |
1.00; 1.04 | — |
| SECONDARY Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline |
1.00; 1.04 | — |
| SECONDARY Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline |
0.93; 1.04 | — |
| SECONDARY Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline |
0.93; 1.04 | — |
| SECONDARY Change in Triglycerides (mg/dL) - Ratio to Baseline |
0.72; 0.96 | — |
| SECONDARY Change in Triglycerides (mmol/L) - Ratio to Baseline |
0.72; 0.96 | — |
| SECONDARY Change in High-sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline |
0.54; 0.89 | — |
| SECONDARY Change in HbA1c (%) |
-0.4; 0.0 | — |
| SECONDARY Change in HbA1c (mmol/Mol) |
-4.5; -0.1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04998136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.