Clinical trial NCT04685993: A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NASH - Nonalcoholic Steatohepatitis
Lead sponsor: Lipocine Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-28
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability of LPCN 1144
timeFrame: Baseline to Week 36
Secondary outcomes:
Other outcomes:
Locations:
city: Roseville
country: United States
facility: Clinical Trials Research
state: California
city: Ocoee
country: United States
facility: Sensible Healthcare, LLC
state: Florida
city: Las Vegas
country: United States
facility: Jubilee Clinical Research, Inc.
state: Nevada
city: Katy
country: United States
facility: R&H Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Sugar Land
country: United States
facility: Pioneer Research Soultions
state: Texas
city: Riverton
country: United States
facility: Advanced Clinical Research - Gut Whisperer
state: Utah
city: West Valley City
country: United States
facility: Granger Medical Clinic
state: Utah
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
Study officials:
affiliation: Lipocine Inc.
name: Anthony DelConte
role: STUDY_DIRECTOR
References: