PWS Clinical Trial: Effects Of GLWL-01 On Hyperphagia, Phase 2

GLWL Research is now recruiting patients for its Phase 2 study to evaluate the efficacy, safety and pharmacokinetics of GLWL-01 in the treatment of patients with Prader-Willi syndrome. The study will compare the effects of GLWL-01 on hyperphagia as compared to a placebo. You can learn more about GLWL-01 in the video below, from the clinical trials session at the 2017 FPWR conferece:

For this study, participants will be assigned to one of two treatment sequences (GLWL-01/Placebo or Placebo/GLWL-01), allowing each patient to experience both the drug and the placebo. Medication will be given through the oral administration of 3 capsules, twice a day.

GLWL-01 Study Sites

Multiple study sites have been identified to date:

Rady Children's Hospital San Diego
San Diego, California, United States, 92123
Contact: Rachel Winograd, 858-966-8453
Principal Investigator: Lynne Bird

University of Florida
Gainesville, Florida, United States, 32601
Contact: Beverly Giordano, 352-294-5280
Principal Investigator: Jennifer Miller

Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Contact: Margo Black, 615-343-5846
Principal Investigator: Ashley Shoemaker

University Hospitals, Cleveland Medical Center
Cleveland, Ohio
Contact: Audrey Lynn 216-844-7124, audrey.lynn@Uhhospitals.org 
Principal Investigator: Shawn McCandless

Alberta Diabetes Institute, University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Contact: Kristie Dehaan, 780-492-1095
Principal Investigator: Andrea Haqq 

CRCHUM
Montreal, Quebec, Canada, H2W 1T8
Contact: Susanne Bordeleau, 514-890-8000
Principal Investigator: Andre Lacroix

Centre Hospilaier Universitaire Ste-Justine
Montreal, Quebec, Canada, H3T 1C5
Contact: Caroline Champagne 514-345-4931 ext 6788
Principal Investigator: Cheri Deal

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:
• Any drugs known to be significant inhibitors of cytochrome P450 (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
• Any drugs known to be significant inducers of CYP3A enzymes and/or P-gp, including St. John's Wort
• Any medications that prolong the QT interval/corrected QT interval (QTc)
• 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

For the latest information on this clinical trial, visit its page on the clinicaltrials.gov website. 

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