A Study of GLWL-01 in Patients With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Intervention: GLWL-01; Placebo
Intervention description: Oral administration of 3 capsules, twice a day; Oral administration of 3 capsules, twice a day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The aim of this study is to evaluate efficacy, safety, and pharmacokinetics of GLWL-01 in the
      treatment of patients with Prader-Willi Syndrome (PWS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of PWS based on genetic confirmation using DNA method

          -  Body mass index (BMI) of 27 to 60 kg/m2

          -  No evidence of weight excursion beyond 10% of baseline weight

          -  Patients must provide assent and have a reliable caregiver (must have been caring for
             the patient for at least 6 months) who provides a separate written informed consent to
             participate. The caregiver is expected to be the primary caregiver throughout the
             study and must be in frequent contact with the patient (defined as at least 4 awake
             hours per day). The caregiver must be able to communicate with site personnel and in
             the investigator's opinion must have adequate literacy to complete questionnaires. If
             a caregiver cannot continue, 1 caregiver replacement is allowed

          -  Are on a stable diet and exercise regimen for >2 months prior

        Exclusion Criteria:

          -  Current enrollment in or discontinuation within the last 30 days from a clinical trial
             involving any investigational drug or device

          -  Are currently living in a group home for more than 50% of the time

          -  A history or presence of other medical illness that indicates a medical problem that
             would preclude study participation

          -  Have an estimated glomerular filtration rate <60 mL/minute/1.73 m2. Have
             macroalbuminuria (defined as spot urine albumin to creatinine ratio of >300 μg/mg) or
             hematuria

          -  Are hypertensive (defined as sitting systolic blood pressure (BP) greater than or
             equal to (≥)140 millimeters of mercury (mmHg) and diastolic BP ≥90 mmHg)

          -  Patients on weight loss medications within 30 days of dosing, or with a history of
             bariatric surgery

          -  Unable to refrain from or anticipates the use of:

               1. Any drugs known to be significant inhibitors of Cytochrome P450, family 3,
                  subfamily A (CYP)3A enzymes and/or P-glycoprotein (P-gp) including regular
                  consumption of grapefruit or grapefruit juice for 14 days prior to the first
                  dose. Acetaminophen (up to 2 grams per 24-hour period) may be permitted

               2. Any drugs known to be significant inducers of Cytochrome P450, family 3,
                  subfamily A (CYP3A) enzymes and/or P-gp, including St. John's Wort

               3. Any medications that prolong the QT/QTc interval, unless the participant has been
                  stable on the medication for at least 3 months and has a corrected QT interval
                  (QTc) <450 msec

          -  Currently taking simvastatin >10 mg per day, atorvastatin >20 mg per day, or
             lovastatin >20 mg per day, or have a history of statin-induced myopathy/rhabdomyolysis

          -  Unsuitable for inclusion in the study in the opinion of the investigator