semaglutide
DrugSemaglutide tablets orally once daily for 64 weeks.
NCT Number: NCT05564117
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
G.A. Research Associates Ltd., Moncton, New Brunswick, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Semaglutide tablets orally once daily for 64 weeks.
Semaglutide placebo-matching tablets orally once daily for 64 weeks.
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.
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.
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.
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.
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.
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'.
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.
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.
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.
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.
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.
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.
Time frame: Baseline (week 0), end of treatment (week 64)
Change in HbA1c from baseline (week 0) to end of treatment (week 64) is presented.
Time frame: Baseline (week 0), end of treatment (week 64)
Change in total cholesterol (measured in millimoles per liter [mmol/L]) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), end of treatment (week 64)
Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), end of treatment (week 64)
Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), end of treatment (week 64)
Change in VLDL cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), end of treatment (week 64)
Change in triglycerides (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), end of treatment (week 64)
Change in free fatty acids (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), end of treatment (week 64)
Change in high sensitivity C-Reactive Protein (hsCRP) (milligram per litre [mg/L]) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Time frame: Baseline (week 0), end of treatment (week 64)
Change in FPG measured in milligrams per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 64) is presented.
Time frame: Baseline (week 0), end of treatment (week 64)
Change in fasting serum insulin measured in picomoles per liter (pmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Time frame: From baseline (week 0) to end of treatment (week 64)
Number of participants with BMI <30 at the end of treatment (week 64) from baseline (week 0) is presented. The outcome measure is applicable for participants with BMI ≥ 30 at baseline (week 0). In the reported data, 'Yes' infers the number of participants who have achieved BMI less than 30, whereas 'No' infers the number of participants who have not achieved BMI less than 30 at week 64.
Time frame: Baseline (week 0), end of treatment (week 64)
Number of participants with change in glycaemic status from baseline (week 0) to the end of treatment (week 64) is presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) <5.7%; 2) Pre-diabetes: 5.7% <= HbA1c < 6.5% 3) Type 2 diabetes: HbA1c >=6.5%.
Time frame: From baseline (week 0) to end of study (week 71)
Number of treatment emergent adverse events from baseline (week 0) to end of study (week 71) is presented. An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.
Time frame: From baseline (week 0) to end of study (week 71)
Number of treatment emergent serious adverse events from baseline (week 0) to end of study (week 71) is presented. A serious adverse event (SAE) is any untoward medical occurrence that fulfils at least one of following criteria: results in death; is life-threatening; requires inpatient or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is congenital anomaly/birth defect; important medical event.
Time frame: Baseline (week 0), end of treatment (week 64)
Change in pulse from baseline (week 0) to end of treatment (week 64) is presented.
Novo Nordisk A/S
Industry
Efficacy and Safety of Oral Semaglutide 25 mg Once Daily in Adults With Overweight or Obesity
Acronym: OASIS 4
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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