A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly
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.
Timeline
- Start
- 2021-05-12
- Primary completion
- 2023-07-10
- Completion
- 2026-05-29
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 NUMBER Paltusotine: 83.3 percentage of participants NUMBER Placebo: 3.6 percentage of participants NCT04837040 ↗
registry analysis (superiority test); Paltusotine vs Placebo; p <0.0001 NCT04837040 ↗
release “positive results by meeting the primary endpoint and all secondary endpoints of the Phase 3 PATHFNDR-1 study ( NCT04837040 ).” 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 |