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An Open Label Extension Study of the Safety and Tolerability of LPCN 1144 for the Treatment of Subjects With Nonalcoholic Steatohepatitis (NASH) Who Have Completed the LPCN 1144-18-002 Trial
This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.
This is a multicenter, open-label extension protocol to provide LPCN 1144, an investigational drug, to subjects with NASH who have completed the LPCN 1144-18-002 protocol. Enrolled subjects will be given LPCN 1144 for up to 36 weeks. Subjects will be seen periodically to evaluate safety clinical laboratory tests, tolerability of LPCN 1144, adverse events, and overall subject health. Subjects will be given the option of having a liver biopsy performed at Week 36.
Age
18 - 80 years
Sex
MALE
Healthy Volunteers
No
Clinical Trials Research
Roseville, California, United States
Sensible Healthcare, LLC
Ocoee, Florida, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, United States
R&H Clinical Research
Katy, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Pioneer Research Soultions
Sugar Land, Texas, United States
Advanced Clinical Research - Gut Whisperer
Riverton, Utah, United States
Granger Medical Clinic
West Valley City, Utah, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Start Date
November 11, 2020
Primary Completion Date
March 1, 2022
Completion Date
March 1, 2022
Last Updated
July 17, 2024
25
ACTUAL participants
LPCN 1144
DRUG
Lead Sponsor
Lipocine Inc.
NCT03587831
NCT03997422
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05479721