With only 80 patients enrolled, secondary indicators showing statistical significant improvements.
However no statistical significant improvements in hepatic fat fraction detected to date, however given the early stage of the trial - this is not surprising. Also very difficult to get statistical significant with such a small sample size.
Key thing is that the data committee has recommended the trial to continue with safety and preliminary efficacy data positive.
Primary purpose of a phase 2 trial is to establish safety and find the most effective dosage and patient population. Statistical significant results are a 'bonus' and not necessary to continue to phase III.
Goodluck!
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