NCT03274856

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

A Phase 2 Study to Evaluate Efficacy, Safety, and Pharmacokinetics of GLWL-01 in the Treatment of Patients With Prader-Willi Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: GLWL Research Inc. · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	GLWL-01	Oral administration of 3 capsules, twice a day
DRUG	Placebo	Oral administration of 3 capsules, twice a day

Timeline

• Start date: 2018-02-20
• Primary completion: 2019-06-12
• Completion: 2019-06-12
• First posted: 2017-09-07
• Last updated: 2020-03-27
• Results posted: 2020-03-27

Locations

7 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study