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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 21, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT07348601). This is a study registration, not published results. Lead sponsor: ConSynance Therapeutics. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 12 participants (ESTIMATED). Conditions: Prader-Willi Syndrome. Interventions: DRUG: CSTI-500. Primary outcome measures: Incidence of treatment-emergent adverse events (TEAEs) , 14 weeks; Proportion achieving target CSTI-500 steady-state Cmax with PK-guided dose individualization , 12 weeks; Incidence of clinically significant findings in laboratory values , 12 weeks; Incidence of clinically significant findings in 12-lead electrocardiograms (ECGs) , 12 weeks; Incidence of clinically significant findings in vital signs , 12 weeks. Brief 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.