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

NCT04874350 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: LPCN 1148-21-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Liver Cirrhosis; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Skeletal Muscle Index in LPCN 1148 treated subjects compared to placebo

  24 weeks

Secondary Outcomes (2)

• Change from baseline in Liver Frailty Index in LPCN 1148 treated subjects compared to placebo

  24 weeks

• Change in number of breakthrough hepatic encephalopathy events in LPCN 1148 treated subjects compared to placebo

  24 weeks

Study Arms (2)

LPCN 1148

EXPERIMENTAL

Oral LPCN 1148 capsules, administered as BID.

Drug: LPCN 1148

Placebo

PLACEBO COMPARATOR

Oral matching placebo capsules, administered as BID.

Drug: Placebo

Interventions

LPCN 1148 DRUG

LPCN 1148 is an oral capsule product containing an ester prodrug of bioidentical testosterone, designed to enable absorption via intestinal lymphatics.

LPCN 1148

Placebo DRUG

Oral matching placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Lipocine Inc.: lead

Study Sites (10)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California San Francisco

San Francisco, California, 94117, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Methodist Health System

Dallas, Texas, 75203, United States

Location

University of Texas Southwestern

Dallas, Texas, 75309, United States

Location

Mt.Olympus Medical Research

Houston, Texas, 77030, United States

Location

Intermountain Healthcare

Murray, Utah, 84107, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis; Sarcopenia

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized 1:1 to LPCN 1148 or placebo

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 5, 2021
• Study Start: November 30, 2021
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

US (10)