NCT07348601

A Study of CSTI-500 in Patients With Prader-Willi Syndrome

A Proof-of-Concept Open-Label Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of CSTI-500 in Participants With Prader-Willi Syndrome

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: ConSynance Therapeutics · Industry
• Sex: All
• Age: 13 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a proof-of-concept, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CSTI-500 in participants with genetically confirmed Prader-Willi Syndrome (PWS) who are 13 to 50 years of age. Participants will receive increasing doses of CSTI-500, and blood levels will be measured to guide individualized dosing.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	CSTI-500	CSTI-500 given orally in an open-label, dose-escalation design with individualized dosing.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study