franconian
New member
Summary Results
* ACE-031 was well tolerated at all dose levels and demonstrated a linear pharmacokinetic profile with an average half-life ranging from 10-15 days
* Single doses of ACE-031 at 1 mg/kg and 3 mg/kg produced dose-dependent increases in lean body mass measured by dual energy X-ray absorptiometry (DXA) as early as day 15 that were sustained through day 57
* Subjects given single doses of placebo had a 0.2% decrease in lean body mass at day 57 compared to a 2.4% increase in subjects receiving 1 mg/kg ACE-031 and a 2.6% increase in subjects receiving 3 mg/kg ACE-031
* Subjects given single doses of placebo had a 0.2% decrease in muscle volume assessed by MRI at day 29 compared to a 3.5% increase in subjects receiving 1 mg/kg ACE-031 and 5% increase in subjects receiving 3 mg/kg ACE-031
* ACE-031 favorably affected biomarkers of fat mass (increased adiponectin and decreased leptin) and bone formation and resorption (increased bone-specific alkaline phosphatase (BSAP) and decreased C-terminal type 1 collagen telopeptide (CTX)) at doses of 1 and 3 mg/kg
Phase II started last month
* ACE-031 was well tolerated at all dose levels and demonstrated a linear pharmacokinetic profile with an average half-life ranging from 10-15 days
* Single doses of ACE-031 at 1 mg/kg and 3 mg/kg produced dose-dependent increases in lean body mass measured by dual energy X-ray absorptiometry (DXA) as early as day 15 that were sustained through day 57
* Subjects given single doses of placebo had a 0.2% decrease in lean body mass at day 57 compared to a 2.4% increase in subjects receiving 1 mg/kg ACE-031 and a 2.6% increase in subjects receiving 3 mg/kg ACE-031
* Subjects given single doses of placebo had a 0.2% decrease in muscle volume assessed by MRI at day 29 compared to a 3.5% increase in subjects receiving 1 mg/kg ACE-031 and 5% increase in subjects receiving 3 mg/kg ACE-031
* ACE-031 favorably affected biomarkers of fat mass (increased adiponectin and decreased leptin) and bone formation and resorption (increased bone-specific alkaline phosphatase (BSAP) and decreased C-terminal type 1 collagen telopeptide (CTX)) at doses of 1 and 3 mg/kg
Phase II started last month
