The effect of AOD9604 on weight loss in obese adults.
Phase 2
Completed
- Conditions
- Obesity.Diet and Nutrition - Obesity
- Registration Number
- ACTRN12605000067673
- Lead Sponsor
- Metabolic Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 360
Inclusion Criteria
BMI of >= 30 kg/m2 and = < 45 kg/m2 with a waist circumference of > = 102 cm (males) or >= 95 cm (females) who are otherwise healthy.
Exclusion Criteria
Subjects taking regular medication, diabetes, hypertension, hypersensitivity to hGH-related products, severe or multiple allergies, dieting or participation in any weight reduction programme in the 3 months prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine if orally administered AOD9604 causes a reduction in body weight following daily dosing for 12 weeks. [At screening, baseline and 2, 4, 6, 8 and 12 weeks following treatment. commencement.];To investigate the safety and tolerability profile of AOD9604 following daily dosing for 24 weeks.[At screening, baseline, and 2, 4, 6, 8, 12, 16, 20, and 24 weeks following treatment commencement, and 4 weeks following treatment cessation.]
- Secondary Outcome Measures
Name Time Method