Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range (OASIS 4)

February 23, 2026 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
307

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • G.A. Research Associates Ltd.
    • Ontario
      • Hamilton, Ontario, Canada, L8L 5G8
        • Wharton Med Clin Trials
  • Germany
      • Essen, Germany, 45136
        • InnoDiab Forschung GmbH
      • Lingen, Germany, 49808
        • Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
      • Münster, Germany, 48153
        • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
      • Oldenburg in Holstein, Germany, 23758
        • RED-Institut für medizinische Forschung und Fortbildung GmbH
      • Rehlingen-Siersburg, Germany, 66780
        • Praxis Dr. med. Wenzl-Bauer
      • Stuttgart, Germany, 70378
        • MZM Praxis Drs. Erlinger
      • Villingen-Schwenningen, Germany, 78048
        • Praxis für Prävention und Therapie, Drs Jacob
      • Wangen, Germany, 88239
        • Zentrum für klinische Studien Allgäu Oberschwaben
  • Poland
    • Lower Silesian Voivodeship
      • Legnica, Lower Silesian Voivodeship, Poland, 59-220
        • Beata Miklaszewicz&Dariusz Dabrowski "CARDIAMED" s.j.
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-412
        • ETG Lublin
    • Masovian Voivodeship
      • Siedlce, Masovian Voivodeship, Poland, 08-110
        • ETG Siedlce
      • Warsaw, Masovian Voivodeship, Poland, 02-677
        • ETG Warszawa Sp. z o.o.
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-281
        • Gabinet Leczenia Otylosci i Chorob Dietozaleznych
    • Wielkopolskie Voivodeship
      • Poznan, Wielkopolskie Voivodeship, Poland, 60-589
        • Centrum Zdrowia Metabolicznego
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univsty Of AL At Birmingham
    • California
      • Costa Mesa, California, United States, 92627
        • FDRC
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East West Medical Research Institute_Honolulu
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Accellacare
    • Texas
      • Dallas, Texas, United States, 75390-9302
        • UT Southwestern Med Cntr
    • Virginia
      • Arlington, Virginia, United States, 22206
        • Washington Cntr Weight Mgmt
      • Winchester, Virginia, United States, 22601
        • Selma Medical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Oral semaglutide 25 mg
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).
Drug: Semaglutide
Semaglutide tablets orally once daily for 64 weeks.
Placebo Comparator: Oral semaglutide placebo
Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.
Drug: Placebo semaglutide
Semaglutide placebo-matching tablets orally once daily for 64 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (week 0), end of treatment (week 64)
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.
At end of treatment (week 64)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At end of treatment (week 64)
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.
At end of treatment (week 64)
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.
At end of treatment (week 64)
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'.
Baseline (week 0), end of treatment (week 64)
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.
Baseline (week 0), end of treatment (week 64)
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.
Baseline (week 0), end of treatment (week 64)
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.
Baseline (week 0), end of treatment (week 64)
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.
Baseline (week 0), end of treatment (week 64)
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.
Baseline (week 0), end of treatment (week 64)
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.
Randomisation (week 0), end of treatment (week 64)
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.
Baseline (week 0), end of treatment (week 64)
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).
Baseline (week 0), end of treatment (week 64)
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).
Baseline (week 0), end of treatment (week 64)
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).
Baseline (week 0), end of treatment (week 64)
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).
Baseline (week 0), end of treatment (week 64)
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).
Baseline (week 0), end of treatment (week 64)
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).
Baseline (week 0), end of treatment (week 64)
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).
Baseline (week 0), end of treatment (week 64)
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.
Baseline (week 0), end of treatment (week 64)
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).
Baseline (week 0), end of treatment (week 64)
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.
From baseline (week 0) to end of treatment (week 64)
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%.
Baseline (week 0), end of treatment (week 64)
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.
From baseline (week 0) to end of study (week 71)
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.
From baseline (week 0) to end of study (week 71)
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.
Baseline (week 0), end of treatment (week 64)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9932-4954
  • U1111-1271-9056 (Other Identifier: World Health Organization (WHO))
  • 2021-006534-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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