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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Drug: LPCN 1144


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>LPCN 1144 | Drug: LPCN 1144<br>* Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the safety and tolerability of LPCN 1144 by assessing the number of treatment-related adverse events | Monitor the safety and tolerability of LPCN 1144 | Baseline to Week 36 | 
| Measure the effect of LPCN 1144 on liver injury markers | Monitor the safety and tolerability of LPCN 1144 | Baseline to Week 36 | 
| Measure the effect of LPCN 1144 on serum lipid panels | Monitor the safety and tolerability of LPCN 1144 | Baseline to Week 36 | 
| Measure the effect of LPCN 1144 on hematology panels | Monitor the safety and tolerability of LPCN 1144 | Baseline to Week 36 | 
| Measure the safety and tolerability of LPCN 1144 by assessing changes in patient-reported disease severity using the PGI-S questionnaire | Monitor the safety and tolerability of LPCN 1144 | Baseline to Week 36 |