Status:
COMPLETED
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
Lead Sponsor:
Lipocine Inc.
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
MALE
18-80 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 gi...
Eligibility Criteria
Inclusion
- Subjects who have completed the 38 week study LPCN 1144-18-002 and wish to be treated with LPCN 1144
- Subject must sign the Informed Consent Form to participate in the study
Exclusion
- Has participated or is participating in any other clinical (investigational) study after completion of LPCN 1144-18-002 study
- Subjects who are currently receiving any androgens or estrogens
- Subjects who are not willing to use adequate contraception for the duration of the study
- Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 weeks in the 2 years prior to enrollment
- Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study
Key Trial Info
Start Date :
November 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04685993
Start Date
November 11 2020
End Date
March 1 2022
Last Update
July 17 2024
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trials Research
Roseville, California, United States, 95661
2
Sensible Healthcare, LLC
Ocoee, Florida, United States, 34761
3
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, United States, 89106
4
R&H Clinical Research
Katy, Texas, United States, 77494