GTx, Inc., the Men's Health Biotech Company, today announced that ostarine, a first-in-class selective androgen receptor modulator (SARM), met its primary endpoint in a Phase II proof of concept double blind, randomized, placebo controlled clinical trial in 120 subjects...
(60 elderly men and 60 postmenopausal women
)... A summary of the topline data is as follows
Primary endpoint: total lean body mass (LBM) measured by dual energy x-ray absorptiometry (DEXA) at baseline compared to three months
-- Among all subjects (n=114), ostarine treatment resulted in a dose dependent increase in total lean body mass, with an increase of 1.3 kg compared to baseline and 1.4 kg compared to placebo (p<0.001) at the 3 mg dose. (Note: This is 2.86 pounds and 3.08 pounds respectively.... for a time period of THREE months... a good diet program and exercise program could have easily beat out those figures!
-- Among females (n=56), ostarine treatment resulted in a dose dependent increase in LBM with the 3 mg dose having an increase of 1.7 kg compared to baseline and an increase of 1.4 kg compared to placebo (p=0.02). (Note: That is 3.74 pounds and and 3.08 pounds respectively.... for a time period of THREE months... a good diet program and exercise program could have easily beat out those figures!
-- Among males (n=58), treatment with a 1 mg dose of ostarine resulted in a LBM increase of 0.7 kg compared to baseline and an increase of 1.2 kg compared to placebo (p=0.03), and treatment with a 3 mg dose of ostarine resulted in an increase of 1.0 kg compared to baseline and an increase of 1.4 kg compared to placebo (p=0.005). (Note: Simply shows that the drug is highly dose dependant)
Secondary endpoints: performance, fat mass, bone mineral density, and bone turnover markers
-- In a stair climb functional performance test that measured speed (time to completion) and power exerted (watts), subjects treated with a 3 mg dose of ostarine demonstrated on average a 15.5% faster time to completion (p=0.006) and exerted on average 25.5% more power (p=0.005) than subjects receiving placebo. (Note: Again, simple dietary programs emphasizing protein and proper fats combined with resistance training can readily beat out those figures.
-- Total tissue percent fat decreased compared to placebo in a dose dependent fashion and achieved statistical significance at the 1 mg dose (p=0.02) and 3 mg dose (p=0.006) of ostarine. Total fat mass was lower in subjects receiving either the 3 mg or 1 mg ostarine dose, although not at a statistically significant level
(p = 0.08 for both doses). For subjects receiving the 3 mg ostarine dose, total fat on average declined 0.6 kg compared to placebo
. The site of fat loss differed among male and female subjects, with males losing fat primarily from the trunk and abdomen, and females losing fat primarily from the thighs and legs. (Note: That is a grand total of 1.32 lbs in a THREE MONTH time period... again, a good dietary regimen and exercise program - even at a moderate level - would beat the pants off of those figures
-- In this trial, ostarine had no apparent effect on bone mineral density, and bone turnover markers results were mixed