RecruitingPhase 2NCT07348601

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

Sponsor

ConSynance Therapeutics

Enrollment

12 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Prader-Willi Syndrome

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.

Eligibility

Min Age: 13 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CSTI-500 for people with prader-willi syndrome. The study is currently recruiting participants at 1 location. People eligible for this study include aged 13 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCSTI-500

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

Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT07348601

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