Overview
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
Status:
Enrolling by invitation
Enrolling by invitation
Trial end date:
2022-08-01
2022-08-01
Target enrollment:
0
0
Participant gender:
Male
Male
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Lipocine Inc.
Criteria
Inclusion Criteria:1. Subjects who have completed the 38 week study LPCN 1144-18-002 and wish to be treated
with LPCN 1144
2. Subject must sign the Informed Consent Form to participate in the study
Exclusion Criteria:
1. Has participated or is participating in any other clinical (investigational) study
after completion of LPCN 1144-18-002 study
2. Subjects who are currently receiving any androgens or estrogens
3. Subjects who are not willing to use adequate contraception for the duration of the
study
4. 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
5. Any other condition, which in the opinion of the investigator would impede compliance
or hinder completion of the study