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
Verified date | February 2022 |
Source | Lipocine Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Lipocine Inc. |
United States,
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 |
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