Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range
ID: NCT05564117
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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.
Semaglutide tablets orally once daily for 64 weeks.
Semaglutide placebo-matching tablets orally once daily for 64 weeks.
Treatment Arms Description
Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 64 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), and 25 mg (weeks 13 to 64).
Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.
- 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
- 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
Primary Outcome Measures
- Percentage Change in Body Weight — Time Frame: Baseline (week 0), end of treatment (week 64)
Percentage change in body weight from baseline (week 0) to end of treatment (week 64) is presented.
- Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No) — Time Frame: At end of treatment (week 64)
Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.
View Secondary Outcome Measures (25)
- Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No) — Time Frame: At end of treatment (week 64)
Number of participants who achieved ≥ 10% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction.
- Number of Participants Who Achieved Body Weight Reduction ≥ 15% (Yes/No) — Time Frame: At end of treatment (week 64)
Number of participants who achieved ≥ 15% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 15% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 15% weight reduction.
- Number of Participants Who Achieved Body Weight Reduction ≥ 20% (Yes/No) — Time Frame: At end of treatment (week 64)
Number of participants who achieved ≥ 20% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 20% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 20% weight reduction.
- Change in Physical Function Domain (5-items) Score Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT) — Time Frame: Baseline (week 0), end of treatment (week 64)
Change in physical function domain score IWQOL-Lite-CT from baseline (week 0) to the end of treatment (week 64) is presented. IWQOL-Lite-CT is a 20-item obesity-specific PRO measures used to assess the impact of body weight changes on patient's physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial functioning (13 items) in 3 composite scores (Physical Function, Physical and Psychosocial) and a Total score, all ranging from 0 to 100 with higher scores reflecting better levels of functioning. This outcome measure shows results for 'physical function domain'.
- Number of Participants Who Achieved ≥14.6 IWQOL-Lite-CT Physical Function Domain (PFD) Score (Yes/No) — Time Frame: Baseline (week 0), end of treatment (week 64)
Number of participants who achieved ≥14.6 in IWQOL-Lite-CT PFD score (Yes/No) from baseline to end of treatment (week 64) is presented. IWQOL-Lite-CT is a 20-item obesity-specific PRO measures used to assess the impact of body weight changes on patient's physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial functioning (13 items) in 3 composite scores (Physical Function, Physical and Psychosocial) and a Total score, all ranging from 0 to 100 with higher scores reflecting better levels of functioning.
- Change in Body Weight - Kilogram (kg) — Time Frame: Baseline (week 0), end of treatment (week 64)
Change in body weight from baseline (week 0) to end of treatment (week 64) is presented.
- Change in Body Mass Index (BMI) — Time Frame: Baseline (week 0), end of treatment (week 64)
Change in BMI from baseline (week 0) to end of treatment (week 64) is presented.
- Change in Waist Circumference — Time Frame: Baseline (week 0), end of treatment (week 64)
Change in waist circumference from baseline (week 0) to end of treatment (week 64) is presented.
- Change in Systolic Blood Pressure — Time Frame: Baseline (week 0), end of treatment (week 64)
Change in systolic blood pressure from baseline (week 0) to end of treatment (week 64) is presented.
- Change in Diastolic Blood Pressure — Time Frame: Randomisation (week 0), end of treatment (week 64)
Change in diastolic blood pressure from randomisation (week 0) to end of treatment (week 64) is presented.
This trial is recruiting at 23 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 23 Facilities & Contact Sites
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- Wharton S, Lingvay I, Bogdanski P, Duque do Vale R, Jacob S, Karlsson T, Shaji C, Rubino D, Garvey WT; OASIS 4 Study Group. Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity. N Engl J Med. 2025 Sep 18;393(11):1077-1087. doi: 10.1056/NEJMoa2500969.PubMed ↗
View Official Medical/Scientific Title
Efficacy and Safety of Oral Semaglutide 25 mg Once Daily in Adults With Overweight or Obesity