A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Phase II Trial of JKB-121 for the Treatment of Nonalcoholic Steatohepatitis (NASH)
Status: Completed
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice daily and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in patients with biopsy-proven nonalcoholic steatohepatitis
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years
• Provision of written informed consent
• Biopsy-proven NASH within 12 months or at screening
• ALT \> 40 U/L for women and \> 60 U/L for men at screening and at least once in the previous 12 months.
• HBA1C of ≤ 9.0
Locations
United States
Alabama
Digestive Disease Specialists of the Southeast
Dothan
Illinois
Northwestern University Feinberg School of Medicine
Chicago
North Carolina
Duke University
Durham
Nevada
Digestive Associates
Las Vegas
Ohio
Digestive Disease Specialists
Cincinnati
Texas
Brook Army Medical Center
Houston
Virginia
University of Virginia Health Systems
Charlottesville
Medical College of Virginia
Richmond
Time Frame
Start Date: 2015-08-01
Completion Date: 2017-09-24
Participants
Target number of participants: 65
Treatments
Active_comparator: A
JKB 121, 5 mg twice daily
Active_comparator: B
JKB 121, 10 mg twice daily
Placebo_comparator: C
Identical appearing placebo
Authors
Stephen A Harrison, Stephen H Caldwell, Arun J Sanyal, Mark E Jonas, Samuel J Tarwater, Zeid K Kayali, Manal F Abdelmalek, Mary Rinella
Related Therapeutic Areas
Sponsors
Leads: Manal Abdelmalek