Phase 3
Completed N=307
Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range
Source: ClinicalTrials.gov NCT05564117 ↗Enrolled (actual)
307
Serious AEs
5.6%
Results posted
Feb 2026
Primary outcomePrimary: Percentage Change in Body Weight — -14.4; -2.5 Percentage change in body weight — p=<0.0001
◆ Published Evidence
Established
63citations · ~63 / year
Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity.
Summary
This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. Participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.
Linked Publications
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Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Body Weight |
-14.4; -2.5 | <0.0001 sig |
| PRIMARY Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No) |
152; 28; 40; 62 | <0.0001 sig |
| SECONDARY Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No) |
121; 13; 71; 77 | — |
| SECONDARY Number of Participants Who Achieved Body Weight Reduction ≥ 15% (Yes/No) |
96; 5; 96; 85 | — |
| SECONDARY Number of Participants Who Achieved Body Weight Reduction ≥ 20% (Yes/No) |
57; 3; 135; 87 | — |
| SECONDARY Change in Physical Function Domain (5-items) Score Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT) |
16.8; 8.3 | — |
| SECONDARY Number of Participants Who Achieved ≥14.6 IWQOL-Lite-CT Physical Function Domain (PFD) Score (Yes/No) |
104; 31; 84; 58 | — |
| SECONDARY Change in Body Weight - Kilogram (kg) |
-15.0; -2.3 | — |
| SECONDARY Change in Body Mass Index (BMI) |
-5.3; -0.9 | — |
| SECONDARY Change in Waist Circumference |
-12.9; -3.1 | — |
| SECONDARY Change in Systolic Blood Pressure |
-7; -5 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-3; -2 | — |
| SECONDARY Change in Glycosylated Haemoglobin (HbA1c) |
-0.3; -0.0 | — |
| SECONDARY Change in Total Cholesterol - Ratio to Baseline |
0.96; 0.98 | — |
| SECONDARY Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline |
1.04; 0.99 | — |
| SECONDARY Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline |
0.96; 0.99 | — |
| SECONDARY Change in Very Low-Density Lipoproteins (VLDL) Cholesterol - Ratio to Baseline |
0.80; 0.92 | — |
| SECONDARY Change in Triglycerides - Ratio to Baseline |
0.80; 0.93 | — |
| SECONDARY Change in Free Fatty Acids - Ratio to Baseline |
0.86; 0.95 | — |
| SECONDARY Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline |
0.50; 0.91 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
-7.3; 0.1 | — |
| SECONDARY Change in Fasting Serum Insulin - Ratio to Baseline |
0.74; 1.03 | — |
| SECONDARY Number of Participants With Body Mass Index (BMI) Less Than (<) 30 at Week 64 (Yes/no) |
77; 9; 102; 77 | — |
| SECONDARY Number of Participants With Change in Glycaemic Status |
92; 35; 5; 11; 0; 0 | — |
| SECONDARY Number of Treatment Emergent Adverse Events (TEAEs) |
1239; 432 | — |
| SECONDARY Number of Serious Treatment Emergent Adverse Events |
17; 13 | — |
| SECONDARY Change in Pulse |
2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- Body mass index (BMI) of
- Greater than or equal to 27.0 kg/m^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular (CV) disease OR
- Greater than or equal to 30.0 kg/m^2
- History of at least one self-reported unsuccessful dietary effort to lose body weight
Exclusion Criteria
- A self-reported change in body weight greater than 5 kg (11 pound [lbs]) within 90 days before screening irrespective of medical records
- HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
Data sourced from ClinicalTrials.gov (NCT05564117) and the linked publication. 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. Informational only — not medical advice.