TT-401: Proof-of-concept trial data
A multiple ascending-dose proof-of-concept (POC) trial in 60 Type II diabetic and non-diabetic obese patients showed that the 3 highest dose levels of once-weekly TT-401 significantly reduced mean FPG from baseline to week 5 vs. placebo in Type II diabetics. Additionally, the 3 highest dose levels of TT-401 significantly reduced body weight relative to baseline. Transition said that a similar reduction in body weight was also observed in the cohort of non-diabetic obese patients who received a single dose level of once-weekly TT-401 for 5 weeks. TT-401 was tolerable at all dose levels in both diabetics and non-diabetic obese patients. The most common adverse event was decreased appetite. Non-diabetics received 1 dose level of TT-401, while diabetics received 1 of 5 dose levels of TT-401 or placebo. Diabetics were also on stable doses of metformin. Transition said the data support a larger Phase II trial with TT-401, but did not disclose details. ...