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

Phase 2

Completed

• Conditions: NASH - Nonalcoholic Steatohepatitis
• Interventions: Drug: LPCN 1144

• Registration Number: NCT04685993
• Lead Sponsor: Lipocine Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-11-11
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Status Verified: 2024-03
• Results First Submitted: 2024-06-25
• Results First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Results First Posted: 2024-07-17
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment A	LPCN 1144	LPCN 1144

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of LPCN 1144	Baseline to Week 36	Number of subjects presenting with a treatment-emergent adverse events

Trial Locations

Locations (10)

Sun Research Institute; 🇺🇸 San Antonio, Texas, United States

Sensible Healthcare, LLC; 🇺🇸 Ocoee, Florida, United States

Clinical Trials Research; 🇺🇸 Roseville, California, United States

Jubilee Clinical Research, Inc.; 🇺🇸 Las Vegas, Nevada, United States

R&H Clinical Research; 🇺🇸 Katy, Texas, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States

Pioneer Research Soultions; 🇺🇸 Sugar Land, Texas, United States

Advanced Clinical Research - Gut Whisperer; 🇺🇸 Riverton, Utah, United States

Manassas Clinical Research Center; 🇺🇸 Manassas, Virginia, United States

Granger Medical Clinic; 🇺🇸 West Valley City, Utah, United States