Research study investigating how well semaglutide works in people suffering from overweight or obesity
- Conditions
- ObesityMedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2017-003436-36-BG
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1950
Main phase:
1. Male or female, age = 18 years at the time of signing informed consent
2. Body mass index (BMI) = 30 kg/sqm or = 27 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
3. History of at least one self-reported unsuccessful dietary effort to lose body weight
Extension phase:
1. Informed consent for the extension phase obtained before any trial related activities for the extension phase
2. On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo
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 1560
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 390
Main phase:
1. HbA1C = 48 mmol/mol (6.5%) 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
Extension phase:
1. Female who is pregnant or intends to become pregnant during the extension phase
2. Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion, might jeopardise the subject’s compliance with the extension of the trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on body weight;Primary end point(s): 1. Change in body weight (%)<br>2. Subjects who achieve body weight reduction = 5% (yes/no);Timepoint(s) of evaluation of this end point: 1. From baseline at week 0 to week 68 <br>2. After 68 weeks from baseline at week 0;Secondary Objective: 1. To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on:<br>- Cardiovascular risk factors<br>- Clinical Outcome Assessments (COAs)<br>2. To compare the safety and tolerability of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Subjects who achieve (yes/no):<br>- Body weight reduction = 10% <br>- Body weight reduction = 15% <br>2. Change in:<br>- Waist circumference (cm)<br>- Systolic blood pressure (mmHg)<br>- Physical functioning score (SF-36)<br>- Physical function domain (5-items) score (IWQoL-Lite for CT);Timepoint(s) of evaluation of this end point: 1. After 68 weeks from baseline at week 0<br>2. From baseline at week 0 to week 68