Build status - In Progress

A Randomized Controlled Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with Non-pharmacologically Treated Acromegaly

Recruiting
99 years or below
All
Phase 3
5 participants needed
1 Location

Brief description of study

1) To evaluate the effect of paltusotine versus placebo on IGF-1(Insulin-like growth factor) response 2) To evaluate the effect of paltusotine versus placebo on IGF-1 level 3) To evaluate the effect of paltusotine versus placebo on GH (growth hormone) response 4) To evaluate the effect of paltusotine versus placebo on acromegaly symptoms 1. Proportion of subjects who maintain biochemical response in IGF-1 (less than or equal to 1.0X the upper limit of normal (ULN) at the End of The Randomized Control Phase 1.Change from baseline in IGF-1, in units of ULN, to EOR 2. Proportion of subjects who achieve IGF-1 less than 1.3X ULN at EOR 3.Proportion of subjects with GH less than 1.0 ng/ml at Week 22 4. Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Medical Research
  • Age: 99 years or below
  • Gender: All
Updated on 08 Feb 2023. Study ID: 852026

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