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

Completed · Phase 2

Conditions studied: NASH - Nonalcoholic Steatohepatitis

In brief

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.

Key facts

Study ID

NCT04685993

Run by

Lipocine Inc.

People needed

25

Starts

2020-11-11

Expected to finish

2022-03-01

Last updated by the study team

2024-07-17

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who have completed the 38 week study LPCN 1144-18-002 and wish to be treated with LPCN 1144
• Subject must sign the Informed Consent Form to participate in the study

You may not qualify if…

• Has participated or is participating in any other clinical (investigational) study after completion of LPCN 1144-18-002 study
• Subjects who are currently receiving any androgens or estrogens
• Subjects who are not willing to use adequate contraception for the duration of the study
• 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
• Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study

Where it is running

• Clinical Trials Research — Roseville, California, United States
• Sensible Healthcare, LLC — Ocoee, Florida, United States
• Jubilee Clinical Research, Inc. — Las Vegas, Nevada, United States
• R&H Clinical Research — Katy, Texas, United States
• Sun Research Institute — San Antonio, 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
• Granger Medical Clinic — West Valley City, Utah, United States
• Manassas Clinical Research Center — Manassas, Virginia, United States

Full record on ClinicalTrials.gov

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