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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
ConSynance Therapeutics
Study ID
NCT07348601
Phase
PHASE2
Status
Recruiting
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Conditions

  • Prader-Willi Syndrome

Eligibility Criteria

Sex
ALL
Age
13 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CSTI-500 (Open-label) Low Target Exposure
  • Experimental: CSTI-500 (Open-Label) Medium Target Exposure
  • Experimental: CSTI-500 (Open-label) High Target Exposure

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: 14 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Elizabeth Roof
[email protected]
6153433330

Find similar trials in Nashville, TN

By research site
Vanderbilt University Medical Center· Nashville, TN

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