Research study looking at how well semaglutide works in people living with obesity and prediabetes
- Conditions
- Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersObesity
- Registration Number
- EUCTR2020-002939-29-FI
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 201
- Male or female aged above or equal to 18 years at the time of signing informed consent.
- BMI greater than or equal to 30.0 kg/m^2
- Prediabetes defined as at least one of the following:
a) HbA1c between 6.0 and 6.4 % (42 and 47 mmol/mol) (both inclusive) as measured by central laboratory at screening.
b) FPG between 5.5 and 6.9 mmol/L (99 and 125 mg/dL) (both inclusive) as measured by central laboratory at screening.
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 185
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
- History of type 1 or type 2 diabetes.
- Treatment with glucose-lowering agent(s) within 90 days before screening.
- HbA1c greater than or equal to 6.5 % (greater than or equal to 48 mmol/mol) as measured by central laboratory at screening.
- FPG greater than or equal to 7.0mmol/L (126 mg/dL) as measured by central laboratory at screening.
- A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.
- Treatment with any medication for the indication of obesity within the past 90 days before screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method