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

Lipocine Inc.25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

NASH - Nonalcoholic Steatohepatitis

Interventions

LPCN 1144DRUG

Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (10)

Clinical Trials Research

Roseville, California, United States

Sensible Healthcare, LLC

Ocoee, Florida, United States

Jubilee Clinical Research, Inc.

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

Safety and Tolerability of LPCN 1144

Number of subjects presenting with a treatment-emergent adverse events

Time frame: Baseline to Week 36

Data from ClinicalTrials.gov

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