A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)
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.
Timeline
- Start
- 2021-12-17
- Primary completion
- 2024-01-20
- Completion
- 2026-06-02
Outcome
Met primary endpoint
Stopped (Business): “The study was stopped early for business reasons (not due to changes in the benefits or risks of paltusotine).”
registry Paltusotine vs Placebo; p <0.0001; Odds Ratio (OR) 42.806 NCT05192382 ↗
release “Crinetics’ Once-Daily Oral Paltusotine Achieved the Primary and All Secondary Endpoints in the Phase 3 PATHFNDR-2 Study in Acromegaly Patients” crinetics.com ↗
release “Phase 3 PATHFNDR-2 study achieved primary and all secondary endpoints” crinetics.com ↗
release “All primary and secondary endpoints were met in both Phase 3 studies.” crinetics.com ↗
release “All primary and secondary endpoints were met in both Phase 3 studies.” crinetics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paltusotine | Small molecule | — | Oral |