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)

Efficacy and safety of oral semaglutide 25 mg once daily in adults with overweight or obesity (OASIS 4) - OASIS 4

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006534-40-PL

Enrollment

300

Registered

2022-08-12

Start date

2022-09-21

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Rybelsus 3 mg tablets Pharmaceutical Form: Tablet INN or Proposed INN: SEMAGLUTIDE CAS Number: 910463-68-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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 2. Male or female, age greater than or equal to 18 years at the time of signing informed consent. 3. Body mass index (BMI) of a) 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 b) Greater than or equal to 30.0 kg/m^2. 4. History of at least one self-reported unsuccessful dietary effort to lose body weight Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: 1. A self-reported change in body weight greater than 5 kg within 90 days before screening irrespective of medical records 2. HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening

Design outcomes

Primary

Measure	Time frame
Main Objective: To confirm superior efficacy on body weight reduction from baseline (week 0) to end of treatment (week 64) of oral semaglutide 25 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity in adults with overweight or obesity.;Secondary Objective: - To confirm superior efficacy on physical function from baseline (week 0) to end of treatment (week 64) of oral semaglutide 25 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity in adults with overweight or obesity. - To estimate the efficacy on cardio-metabolic parameters from baseline (week 0) to end of treatment (week 64) of oral semaglutide 25 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity in adults with overweight or obesity. - To compare the safety and tolerability from baseline (week 0) to end of study (week 71) of oral semaglutide 25 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity in adults with overweight or obesity.;Primary end point(s): 1. Relative change in body weight 2. Achievement of body weight reduction = 5% (Yes/No);Timepoint(s) of evaluation of this end point: 1. From baseline (week 0) to end of treatment (week 64). 2.. At end-of-treatment (week 64)	—

Measure

Time frame

Main Objective: To confirm superior efficacy on body weight reduction from baseline (week 0) to end of treatment (week 64) of oral semaglutide 25 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity in adults with overweight or obesity.;Secondary Objective: - To confirm superior efficacy on physical function from baseline (week 0) to end of treatment (week 64) of oral semaglutide 25 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity in adults with overweight or obesity. - To estimate the efficacy on cardio-metabolic parameters from baseline (week 0) to end of treatment (week 64) of oral semaglutide 25 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity in adults with overweight or obesity. - To compare the safety and tolerability from baseline (week 0) to end of study (week 71) of oral semaglutide 25 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity in adults with overweight or obesity.;Primary end point(s): 1. Relative change in body weight 2. Achievement of body weight reduction = 5% (Yes/No);Timepoint(s) of evaluation of this end point: 1. From baseline (week 0) to end of treatment (week 64). 2.. At end-of-treatment (week 64)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Achievement of body weight reduction = 10% (Yes/No) 2. Achievement of body weight reduction = 15% (Yes/No) 3. Achievement of body weight reduction = 20% (Yes/No) 4. Change in Physical function domain (5-items) score (Impact of Weight on Quality of Life-Lite-Clinical Trials version [IWQOL-Lite-CT]) 5. Change in body mass index (BMI) 6. Change in waist circumference 7. Change in systolic blood pressure 8. Change in diastolic blood pressure 9. Change in HbA1c 10. Change in lipids: • Total cholesterol • HDL cholesterol • LDL cholesterol • VLDL cholesterol • Triglycerides • Free fatty acids 11. Change in high sensitivity C Reactive Protein 12. Change in fasting plasma glucose (FPG) 13. Change in fasting serum insulin 14. Number of treatment emergent adverse events 15. Number of treatment emergent serious adverse events;Timepoint(s) of evaluation of this end point: 1-3. At end-of-treatment (week 64) 4- 7. From baseline (week 0) to end of treatment (week 64) 8. From randomisation (week 0) to end of treatment (week 64) 9- 13. From baseline (week 0) to end of treatment (week 64) 14 - 15. From baseline (week 0) to end of study (week 71)	—

Measure

Time frame

Secondary end point(s): 1. Achievement of body weight reduction = 10% (Yes/No) 2. Achievement of body weight reduction = 15% (Yes/No) 3. Achievement of body weight reduction = 20% (Yes/No) 4. Change in Physical function domain (5-items) score (Impact of Weight on Quality of Life-Lite-Clinical Trials version [IWQOL-Lite-CT]) 5. Change in body mass index (BMI) 6. Change in waist circumference 7. Change in systolic blood pressure 8. Change in diastolic blood pressure 9. Change in HbA1c 10. Change in lipids: • Total cholesterol • HDL cholesterol • LDL cholesterol • VLDL cholesterol • Triglycerides • Free fatty acids 11. Change in high sensitivity C Reactive Protein 12. Change in fasting plasma glucose (FPG) 13. Change in fasting serum insulin 14. Number of treatment emergent adverse events 15. Number of treatment emergent serious adverse events;Timepoint(s) of evaluation of this end point: 1-3. At end-of-treatment (week 64) 4- 7. From baseline (week 0) to end of treatment (week 64) 8. From randomisation (week 0) to end of treatment (week 64) 9- 13. From baseline (week 0) to end of treatment (week 64) 14 - 15. From baseline (week 0) to end of study (week 71)

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Countries

Canada, European Union, Poland, United States

Contacts

Public ContactClinical Transparency (2834)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026