A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Liver Cirrhosis, Sarcopenia

In brief

This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of LPCN 1148 in men with cirrhosis of the liver and sarcopenia.

Key facts

Study ID

NCT04874350

Run by

Lipocine Inc.

People needed

30

Starts

2021-11-30

Expected to finish

2023-12-18

Last updated by the study team

2024-03-15

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male ≥ 18 years old
• Currently listed, on the liver transplant waitlist for cirrhosis secondary to Hepatitis B or C infection, Alcoholic Liver Disease (ALD), Non-Alcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC), or Primary Sclerosing Cholangitis (PSC)
• Evidence of sarcopenia with appropriate cutoff recommended by clinical guidance

You may not qualify if…

• Suspected or proven hepatocellular carcinoma (HCC)
• History of current or suspected prostate or breast cancer
• History of malignancies other than prostate, breast, or HCC, unless successfully treated with curative intent and believed to be cured (defined as complete remission lasting at least 5 years)
• History of uncontrolled or recurrent portal hypertensive bleeding, including uncontrolled or recurrent bleeding from varices, gastropathy, colopathy, or hemorrhoidal bleeding in the past 6 months.
• History or current thrombosis (including portal vein thrombosis), thromboembolism, or treatment for portal vein thrombosis
• History of hemochromatosis
• History of hypercoagulable state (e.g. Factor V Leiden deficiency, protein C deficiency, protein S deficiency, anti-thrombin III deficiency, or the presence of lupus anticoagulant)
• Prior history of complications of ascites in the past 6 months including:
• Spontaneous bacterial peritonitis
• Hepatic hydrothorax
• MELD score > 25
• Abnormal lab value in serum chemistry, hematology, or urinalysis that the PI considers clinically significant, including but not limited to:
• PSA > 4 ng/mL
• Polycythemia (Hematocrit > ULN) or history of polycythemia
• ALT or AST > 5x ULN
• ALP > 2x ULN; subjects with PBC or PSC are excluded if ALP is > 10x ULN
• Platelet count < 30,000/mL
• EGFR < 30 mL/min/1.73 m2 for subjects not undergoing routine, scheduled dialysis
• Serum albumin < 2.0 g/dL
• INR > 2.3
• Subjects with PSA between 2.5 ng/mL and 4 ng/mL are excluded only if any of the below criteria are met at baseline:
• Hematocrit > 48%
• I-PSS > 19
• Any irregularity found on digital rectal examination of the prostate
• Subjects with PSA > 3 ng/mL are excluded only if any of the below criteria are met at baseline:

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Methodist Health System — Dallas, Texas, United States
• University of Texas Southwestern — Dallas, Texas, United States
• Mt.Olympus Medical Research — Houston, Texas, United States
• Intermountain Healthcare — Murray, Utah, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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