The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Steatohepatitis (NASH)

In brief

This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH.

Key facts

Study ID

NCT04134091

Run by

Lipocine Inc.

People needed

56

Starts

2019-08-27

Expected to finish

2021-06-24

Last updated by the study team

2023-12-14

Who can join

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

You may qualify if…

• Male between 18 and 80 years of age, inclusive.
• Subject with histologic evidence of NASH upon central read of a liver biopsy.
• i. A historical biopsy no more than 4 months before Screening may be considered for use with medical monitor approval if the following criteria are met:
• Stable weights between the time of the biopsy and Screening. Stable weight is defined as no more than a 5% change.
• Is either not taking or is on a stable dose of Thiazolidinedione(TZDs)/glitazones for 3 months before Day 1.
• Background therapy for other ongoing chronic conditions, and weight should be stable for at least 3 months before trial enrollment. Stable weight is defined as no more than a 5% change.
• Judged to be in good general health as determined by the investigator at screening.

You may not qualify if…

• Significant alcohol consumption more than 30 g/day on average, either currently or for a period of more than 3 consecutive months in the 5 years prior to screening.
• Inability to reliably quantify alcohol intake.
• Biochemical, clinical or histologic evidence of cirrhosis on liver biopsy (stage 4 fibrosis).
• Evidence of other causes of chronic liver disease including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus, etc.
• Suspected or proven liver cancer.
• Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
• Hematocrit > upper limits of normal (ULN)
• Hemoglobin > ULN
• Prostate-specific antigen (PSA) > 4 ng/mL
• Serum aspartate aminotransferase (AST) or alanine transaminase (ALT) > 200 IU/L
• Serum alkaline phosphatase (ALP) > 2 x ULN
• Serum creatinine of 2.0 mg/dL or greater
• Total bilirubin > ULN
• International normalized ratio (INR) ≥ 1.3.
• Prolactin > ULN
• Subjects with evidence of worsening liver function based on the two initial laboratory values used to establish the screening / baseline values.
• Model for End-Stage Liver Disease (MELD) score greater than 12
• Subjects with a documented history of Gilbert's syndrome
• Evidence of portal hypertension (e.g., low platelet counts, esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly).
• 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 randomization.
• Subjects who are not on a stable dose of lipid-lowering drugs, diabetic and / or hypertensive medication in the 3 months prior to biopsy or the 3 months prior to randomization
• Any over-the-counter medication or herbal remedy that is being taken with an intent to improve hyperlipidemia must be stable for at least 3 months prior to randomization and through the end of the study.
• Vitamin E supplementation of greater than 100 IU/day, unless completed adequate washout for at least 4 weeks prior to Day 1 or biopsy if one is required.
• Inability to safely obtain a liver biopsy.
• History of total parenteral nutrition in the year prior to screening.

Where it is running

• TriWest Research Associates, LLC — El Cajon, California, United States
• United Medical Doctors — Murrieta, California, United States
• Inland Empire Liver Foundation — Rialto, California, United States
• Clinical Trials Research — Roseville, California, United States
• Meridien Research-Maitland — Maitland, Florida, United States
• Clinical Pharmacology of Miami, LLC — Miami, Florida, United States
• Sensible Healthcare, LLC — Ocoee, Florida, United States
• Tandem Clinical Research — Marrero, Louisiana, United States
• Jubilee Clinical Research, Inc. — Las Vegas, Nevada, United States
• Clinical Research of South Nevada — Las Vegas, Nevada, United States
• Awasty Research Network — Marion, Ohio, 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
• Clinical Trial Network-Houston — Spring, 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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