Efficacy and safety of oral semaglutide 50 mg once daily in subjects with overweight or obesity
Phase 3
- Conditions
- Obesity
- Registration Number
- JPRN-jRCT2031210297
- Lead Sponsor
- ishida Hiroko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Male or female, age >= 18 years at the time of signing informed consent
2. Body mass index (BMI):
a) >=27.0 kg/m2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
b)>= 30.0 kg/m2
3. History of at least one self-reported unsuccessful dietary effort to lose body weight
Exclusion Criteria
1. HbA1c >=6.5% (48 mmol/mol) as measured by the central laboratory at screening
2. A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoints:<br>1. Ralative change in body weight from baseline to end-of-treatment (%-point)<br>2. Achievement of body weight reduction >= 5% (Yes/No) at end-of-treatment (count of subjects)
- Secondary Outcome Measures
Name Time Method