At a glance
ClinicalIndex Comparison RecordPhase 3Active· 58 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, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Acromegaly Treated With Long-acting Somatostatin Receptor Ligands (PATHFNDR-1)
In Brief
A Phase 3 clinical trial evaluating Paltusotine and Placebo for Acromegaly. Active but no longer recruiting, targeting 58 participants across 39 sites in 14 countries.
Detailed Summary
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcromegaly
CountriesArgentina, Belgium, Brazil, Bulgaria, France, Hungary, Israel, Italy, Peru, Poland, Russia, Serbia, United Kingdom, United States
Collaborators--
Timeline
Phase 3Active
202220232024202520262027
First PostedApr 2021
Enrollment StartMay 2021
Primary CompletionJul 2023
TodayJul 2026
Study CompletionJun 2027
First PostedApr 8, 2021
Enrollment StartMay 12, 2021
Primary CompletionJul 10, 2023
Study CompletionJun 1, 2027
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.2 years ago
Interventions
Paltusotinedrug
Paltusotine, tablets, once daily by mouth
Placebodrug
Placebo, tablets, once daily by mouth