A Study to Assess the Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis (NASH)
Summary
This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH.
Description
This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH. The study will be conducted across multiple centers in the United States.
Approximately 75 subjects will be randomized in 1:1:1 ratio to receive one of the following treatments:
- Treatment A: Oral LPCN 1144 Formulation A
- Treatment B: Oral LPCN 1144 Formulation B
- Treatment C: Oral matching placebo
Subjects will undergo a screening period to determine study eligibility. As a part of screening, liver biopsies will be performed for subjects who have not had a liver biopsy within 6 months of Day 1, and fat fraction will be measured by MRI-PDFF in all subjects. Adult male subjects with histologic evidence of NASH will be enrolled into the study.
Eligible subjects will be randomized to one of the three treatment arms. The treatment phase will be for a duration of 36-weeks with assessments of liver biopsies, hepatic fat fraction, liver enzymes, lipid levels and other safety parameters. Safety and tolerability will be assessed throughout the study.
Study Design
Conditions
Nonalcoholic Steatohepatitis (NASH)
Intervention
LPCN 1144 Formulation A, LPCN 1144 Formulation B, Placebo
Location
Awasty Research Network
Marion
Ohio
United States
43302
Status
Recruiting
Source
Lipocine Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04134091
- ClinicalTrials.gov processed this data on October 25, 2019
Published on BioPortfolio: 2019-10-28T13:57:27-0400
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