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

NASH - Nonalcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04685993
• Other study ID #: LPCN 1144-20-002
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 11, 2020
• Est. completion date: August 2022

Study information

• Verified date: February 2022
• Source: Lipocine Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

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

Locations

Country	Name	City	State
United States	R&H Clinical Research	Katy	Texas
United States	Jubilee Clinical Research, Inc.	Las Vegas	Nevada
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Sensible Healthcare, LLC	Ocoee	Florida
United States	Advanced Clinical Research - Gut Whisperer	Riverton	Utah
United States	Clinical Trials Research	Roseville	California
United States	Endeavor Clinical Trials	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	Pioneer Research Soultions	Sugar Land	Texas
United States	Granger Medical Clinic	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Lipocine Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Measure the effect of LPCN 1144 on liver injury markers	Monitor the safety and tolerability of LPCN 1144	Baseline to Week 36
Primary	Measure the effect of LPCN 1144 on serum lipid panels	Monitor the safety and tolerability of LPCN 1144	Baseline to Week 36
Primary	Measure the effect of LPCN 1144 on hematology panels	Monitor the safety and tolerability of LPCN 1144	Baseline to Week 36
Primary	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