semaglutide
DrugParticipants will receive semaglutide orally.
Recruiting
NCT Number: NCT07770841
Research Study on How Well Oral Semaglutide Works for Weight Loss in Adults With Excess Body Weight
The purpose of this study is to see how oral semaglutide, when taken in lower doses help lowering of body weight in participants with excess body weight when compared to 'dummy' tablets (placebo). Results from this study will help select the most optimal lower dose of oral semaglutide that can be used for treating participants living with overweight or obesity.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Anima Research Center, Alken, Belgium
Loading trial locations.
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.
- Female or male (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- Body mass index (BMI) of
- ≥ 27.0 kilogram per square meter (kg/m^2) with the presence of at least one weight-related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or CV disease.
OR
- ≥ 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% within 90 days before screening irrespective of medical records.
- HbA1c ≥ 6.5% (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.
- Consistent use of glucagon like peptide-1 (GLP-1) receptor agonists, including medication with glucagon like peptide-1 receptor agonist (GLP-1 RA) activity like dual GLP-1/gastric inhibitory peptide RAs, or amylin analogues before screening. Consistent use is defined as treatment.
Treatment and study plan
Placebo
DrugParticipants will receive placebo orally.
Primary outcomes
-
Relative change in body weight
Time frame: From baseline (week 0) to week 60
Measured as percentage change in body weight.
Secondary outcomes
-
Achievement of body weight reduction greater than or equal to (≥) 5 percentage (%) (Yes/No)
Time frame: At week 60
Measured as count of participant.
-
Achievement of body weight reduction ≥ 10% (Yes/No)
Time frame: At week 60
Measured as count of participant.
-
Achievement of body weight reduction ≥ 15% (Yes/No)
Time frame: At week 60
Measured as count of participant.
-
Change in waist circumference
Time frame: From baseline (week 0) to week 60
Measured as centimeter (cm).
-
Change in body weight
Time frame: From baseline (week 0) to week 60
Measured as kilogram (kg).
-
Change in high sensitivity C-Reactive Protein (hsCRP)
Time frame: From baseline (week 0) to week 60
Measured as milligrams per deciliter (mg/dL).
-
Change in systolic blood pressure
Time frame: From baseline (week 0) to week 60
Measured as millimetres of mercury (mmHg).
-
Change in diastolic blood pressure
Time frame: From baseline (week 0) to week 60
Measured as (mmHg).
-
Change in fasting plasma glucose (FPG)
Time frame: From baseline (week 0) to week 60
Measured as ratio to baseline.
-
Change in glycated haemoglobin (HbA1c)
Time frame: From baseline (week 0) to week 60
Measured as %-point.
-
Change in glycaemic status
Time frame: From baseline (week 0) to week 60
Measured as count of participants.
-
Change in lipids: Total cholesterol
Time frame: From baseline (week 0) to week 60
Measured as ratio to baseline.
-
Change in lipids: High density lipoprotein (HDL) cholesterol
Time frame: From baseline (week 0) to week 60
Measured as ratio to baseline.
-
Change in lipids: Non-HDL cholesterol
Time frame: From baseline (week 0) to week 60
Measured as ratio to baseline.
-
Change in lipids: Low density lipoprotein (LDL) cholesterol
Time frame: From baseline (week 0) to week 60
Measured as ratio to baseline.
-
Change in lipids: Very low density lipoprotein (VLDL) cholesterol
Time frame: From baseline (week 0) to week 60
Measured as ratio to baseline.
-
Change in lipids: Triglycerides
Time frame: From baseline (week 0) to week 60
Measured as ratio to baseline.
-
Change in lipids: Free fatty acids
Time frame: From baseline (week 0) to week 60
Measured as ratio to baseline.
-
Change in waist-height ratio (WtHR)
Time frame: From baseline (week 0) to week 60
Measured as change in waist-height ratio.
-
Number of treatment emergent adverse events
Time frame: From baseline (week 0) to week 67
Measured as count of events.
-
Number of treatment emergent serious adverse events
Time frame: From baseline (week 0) to week 67
Measured as count of events.
-
Number of treatment emergent adverse events leading to permanent treatment discontinuation
Time frame: From baseline (week 0) to week 67
Measured as count of events.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Novo Nordisk A/S
Industry
Registry information
Official study title
Efficacy and Safety of Once Daily Oral Semaglutide in Adults With Overweight or Obesity
Acronym: OASIS 5
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Aug 18, 2026
- Registry last updated
- Aug 18, 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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