A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial

Lipocine

Status and phase: Completed; Phase 2

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Drug: LPCN 1144

Study type: Interventional

Funder types: Industry

Identifiers

NCT04685993

LPCN 1144-20-002

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 25 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Treatment A

Experimental group

Description:

LPCN 1144

Treatment:

Drug: LPCN 1144