At a glance
ClinicalIndex Comparison RecordPhase 3Active· 111 enrolled
Drug / intervention
Paltusotine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Non-pharmacologically Treated Acromegaly (PATHFNDR-2)
In Brief
A Phase 3 clinical trial evaluating Paltusotine and Placebo for Acromegaly. Active but no longer recruiting, targeting 111 participants across 57 sites in 15 countries.
Detailed Summary
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcromegaly
CountriesArgentina, Brazil, Bulgaria, China, France, Germany, Greece, Hungary, India, Israel, Italy, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3Active
2022202320242025202620272028
Enrollment StartDec 2021
First PostedJan 2022
Primary CompletionJan 2024
TodayJul 2026
Study CompletionJan 2028
First PostedJan 14, 2022
Enrollment StartDec 17, 2021
Primary CompletionJan 20, 2024
Study CompletionJan 1, 2028
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 4.5 years ago
Interventions
Paltusotinedrug
Paltusotine, tablets, once daily by mouth
Placebodrug
Placebo, tablets, once daily by mouth