Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity who have reached target dose during run-in period
Phase 3
Completed
- Conditions
- Obesitas en overgewicht met co-morbiditeitenObesityoverweight
- Registration Number
- NL-OMON46356
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
-Informed consent obtained before any trial-related activities
-Male or female, age >= 18 years at the time of signing informed consent
-BMI >= 30 kg/m2 or >= 27 kg/m2 with the presence of at least one of the following weightrelated
comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive
sleep apnoea or cardiovascular disease
-History of at least one self-reported unsuccessful dietary effort to lose body weight
Exclusion Criteria
- HbA1c >= 48 mmol/mol (6.5%) as measured by central laboratory at screening
- 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 <p>Change from randomisation (week 20) to week 68 in body weight (%)</p><br>
- Secondary Outcome Measures
Name Time Method <p>From randomisation (week 20) to week 68 change in waist circumference (cm),<br /><br>systolic blood pressure (mmHg), physical functioning score (SF-36) and total<br /><br>score (Weight Related Sign and Symptom Measure (WRSSM)).</p><br>