At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 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 Double-blind, Placebo-controlled, Randomized Withdrawal Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly That Are Responders to Octreotide LAR or Lanreotide Depot (ACROBAT Evolve)
In Brief
A Phase 2 clinical trial evaluating Paltusotine and Placebo for Acromegaly. Completed, enrolled 13 participants across 11 sites in 8 countries.
Detailed Summary
A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are responders to octreotide LAR or lanreotide depot.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcromegaly
CountriesBrazil, Greece, Hungary, New Zealand, Poland, Serbia, Slovakia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartMar 2019
Primary CompletionJul 2020
Study CompletionAug 2020
TodayJul 2026
First PostedJan 3, 2019
Enrollment StartMar 11, 2019
Primary CompletionJul 15, 2020
Study CompletionAug 12, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.5 years ago
Interventions
Paltusotinedrug
Paltusotine, capsules, once daily by mouth
Placebodrug
Placebo, capsules, once daily by mouth