A Study of GLWL-01 in Patients With Prader-Willi Syndrome
NCT ID: NCT03274856
Last Updated: 2020-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
19 participants
INTERVENTIONAL
2018-02-20
2019-06-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Treatment Sequence 1
GLWL-01 (450mg) twice a day/ Placebo
GLWL-01
Oral administration of 3 capsules, twice a day
Placebo
Oral administration of 3 capsules, twice a day
Treatment Sequence 2
Placebo / GLWL-01 (450mg), twice a day
GLWL-01
Oral administration of 3 capsules, twice a day
Placebo
Oral administration of 3 capsules, twice a day
Interventions
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GLWL-01
Oral administration of 3 capsules, twice a day
Placebo
Oral administration of 3 capsules, twice a day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
65 Years
ALL
No
Sponsors
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GLWL Research Inc.
OTHER
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
GLWL Research Inc.
Locations
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Rady Children's Hospital San Diego
San Diego, California, United States
University of Florida
Gainesville, Florida, United States
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, United States
Vanderbilt University
Nashville, Tennessee, United States
Alberta Diabetes Institute, University of Alberta
Edmonton, Alberta, Canada
CRCHUM
Montreal, Quebec, Canada
Centre Hospitalier Universitaire Ste-Justine
Montreal, Quebec, Canada
Countries
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References
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Miller JL, Lacroix A, Bird LM, Shoemaker AH, Haqq A, Deal CL, Clark KA, Ames MH, Suico JG, de la Pena A, Fortier C. The Efficacy, Safety, and Pharmacology of a Ghrelin O-Acyltransferase Inhibitor for the Treatment of Prader-Willi Syndrome. J Clin Endocrinol Metab. 2022 May 17;107(6):e2373-e2380. doi: 10.1210/clinem/dgac105.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GLWL-PWS
Identifier Type: -
Identifier Source: org_study_id
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