EUCTR2014-001540-38-GB
Active, not recruiting
Phase 1
Investigation of safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus. A 52-week, randomised, double-blind, placebo-controlled, sixteen-armed, parallel group, multi-centre, multinational trial with liraglutide 3.0 mg as active comparator
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 957
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Informed consent obtained before any trial\-related activities. Trial\-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •2\. Male or female, age \= 18 years at the time of signing inform consent
- •3\. Body mass index (BMI) \= 30\.0 kg/m^2 at the screening visit
- •4\. At least one unsuccessful weight loss attempt per investigator judgement
- •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 885
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 50
Exclusion Criteria
- •1\. A HbA1c \= 6\.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus
- •2\. Treatment with glucose lowering agent(s) within 90 days before screening
- •3\. Screening calcitonin \= 50 ng/L (pg/mL)
- •4\. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- •5\. History of pancreatitis (acute or chronic)
- •6\. Obesity induced by endocrine disorders (e.g. Cushing Syndrome)
- •7\.Treatment with any medication within 90 days before screening that based on investigator’s judgement may cause significant weight change
- •8\. Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed \> 1 year before screening is allowed)
- •9\. History of major depressive disorder within 2 years before randomisation
- •10\. Any lifetime history of a suicidal attempt
Outcomes
Primary Outcomes
Not specified
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