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

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

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.

Study Overview

• Status: Completed
• Conditions: NASH - Nonalcoholic Steatohepatitis
• Intervention / Treatment: Drug: LPCN 1144

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Roseville, California, United States, 95661
      • Clinical Trials Research
  • Florida
    • Ocoee, Florida, United States, 34761
      • Sensible HealthCare, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Jubilee Clinical Research, Inc.
  • Texas
    • Katy, Texas, United States, 77494
      • R&H Clinical Research
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute
    • Sugar Land, Texas, United States, 77479
      • Pioneer Research Soultions
  • Utah
    • Riverton, Utah, United States, 84065
      • Advanced Clinical Research - Gut Whisperer
    • West Valley City, Utah, United States, 84120
      • Granger Medical Clinic
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; LPCN 1144	Drug: LPCN 1144; Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).; Other Names: testosterone undecanoate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of LPCN 1144	Number of subjects presenting with a treatment-emergent adverse events	Baseline to Week 36

Collaborators and Investigators

• Sponsor: Lipocine Inc.
• Investigators: Study Director: Anthony DelConte, Lipocine Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: LPCN 1144-20-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No