Skip to content

Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name OASIS 4

NCTNCT05564117 (opens ClinicalTrials.gov in a new tab)Other idNN9932-4954Other idU1111-1271-9056Other id2021-006534-40
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
307 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
4 countries

United States, Canada, Germany, Poland

Start
11 Oct 2022
Primary completion
18 Apr 2024
Completion
7 May 2024
First posted
3 Oct 2022
Last update posted
25 Feb 2026
Conditions
Overweight · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 3

    OASIS 4

    NCT05564117

    11 Oct 2022 to 7 May 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SemaglutideDrug
  • Placebo semaglutideDrug

Arms2

  • 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).

  • Placebo comparator

    Oral semaglutide placebo

    Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percentage Change in Body Weight

    Time frame · Baseline (week 0), end of treatment (week 64)

    Registry description

    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)

    Registry description

    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(20)

  1. Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)

    Time frame · At end of treatment (week 64)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (week 0), end of treatment (week 64)

Percentage Change in Body Weight

GroupValue (Percentage change in body weight)Spread
Oral Semaglutide 25 mg-14.410.5
Placebo-2.57.9
Primary outcomeCount of participants· At end of treatment (week 64)

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)

GroupValue (Participants)
Oral Semaglutide 25 mg152
Placebo28
Secondary and other outcome results(6)
Secondary outcomeCount of participants· At end of treatment (week 64)

Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)

GroupValue (Participants)
Oral Semaglutide 25 mg121
Placebo13
Secondary outcomeCount of participants· At end of treatment (week 64)

Number of Participants Who Achieved Body Weight Reduction ≥ 15% (Yes/No)

GroupValue (Participants)
Oral Semaglutide 25 mg96
Placebo5
Secondary outcomeCount of participants· At end of treatment (week 64)

Number of Participants Who Achieved Body Weight Reduction ≥ 20% (Yes/No)

GroupValue (Participants)
Oral Semaglutide 25 mg57
Placebo3
Secondary outcomeMean· Baseline (week 0), 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)

GroupValue (Score on a scale)Spread
Oral Semaglutide 25 mg16.820.4
Placebo8.316.7
Secondary outcomeCount of participants· 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)

GroupValue (Participants)
Oral Semaglutide 25 mg104
Placebo31
Secondary outcomeMean· Baseline (week 0), end of treatment (week 64)

Change in Body Weight - Kilogram (kg)

GroupValue (kg)Spread
Oral Semaglutide 25 mg-15.011.3
Placebo-2.38.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oral Semaglutide 25 mgParticipants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.0 / 2058 / 204172 / 204
PlaceboParticipants received placebo matched to semaglutide orally once daily up to week 64.0 / 1029 / 10279 / 102

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

7 results

Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity.

Wharton et al. 2025The New England journal of medicinecited by 54

PMID 40934115DOI 10.1056/nejmoa2500969PUB-40934115

Full text at the publisher7 results
Publisher pageSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.