A Study of GLWL-01 in Patients With Prader-Willi Syndrome

Study Purpose

GLWL is conducting a Phase 2 clinical trial to to evaluate the efficacy, safety, and pharmacokinetics of GLWL-01 in treating hyperphagia in patients with PWS. Participants will be assigned to one of two treatment sequences (GLWL-01/Placebo or Placebo/GLWL-01), with each sequence consisting of two treatment periods separated by a washout period.

Recruitment Criteria

Study Type: Randomized, triple-blind, crossover assignment
Eligible Ages: 16 to 65 years
Other Criteria: BMI of 27-60 kg/mw

Trial Details

Trial IdNCT03274856
Phase: 2
Duration: 18 weeks
Status:
 recruiting
Lead Sponsor: GLWL
Countries: United States, Canada
Additional Details: 

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 (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 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

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you. More information on this study is available on the study information page at clincaltrials.gov.  


This Study is enrolling at the following 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

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

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

 

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