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Completed

NCT Number: NCT05564117

Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

G.A. Research Associates Ltd., Moncton, New Brunswick, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

Semaglutide tablets orally once daily for 64 weeks.

Placebo Semaglutide

Drug

Semaglutide placebo-matching tablets orally once daily for 64 weeks.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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'.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Change in Glycosylated Haemoglobin (HbA1c)

    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.

  12. Change in Total Cholesterol - Ratio to Baseline

    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).

  13. Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline

    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).

  14. Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline

    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).

  15. Change in Very Low-Density Lipoproteins (VLDL) Cholesterol - Ratio to Baseline

    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).

  16. Change in Triglycerides - Ratio to Baseline

    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).

  17. Change in Free Fatty Acids - Ratio to Baseline

    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).

  18. Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline

    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).

  19. Change in Fasting Plasma Glucose (FPG)

    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.

  20. Change in Fasting Serum Insulin - Ratio to Baseline

    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).

  21. Number of Participants With Body Mass Index (BMI) Less Than (<) 30 at Week 64 (Yes/no)

    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.

  22. Number of Participants With Change in Glycaemic Status

    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%.

  23. Number of Treatment Emergent Adverse Events (TEAEs)

    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.

  24. Number of Serious Treatment Emergent Adverse Events

    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.

  25. Change in Pulse

    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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Oral Semaglutide 25 mg Once Daily in Adults With Overweight or Obesity

Acronym: OASIS 4

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2022
Registry last updated
Feb 25, 2026

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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