NCT04874350View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 30, 2021

Primary Completion Date

December 18, 2023

Study Completion Date

December 18, 2023

Conditions
Liver CirrhosisSarcopenia
Interventions
DRUG

LPCN 1148

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

DRUG

Placebo

Oral matching placebo capsule

Trial Locations (10)

21201

University of Maryland Medical Center, Baltimore

75203

Methodist Health System, Dallas

75309

University of Texas Southwestern, Dallas

77030

Mt.Olympus Medical Research, Houston

84107

Intermountain Healthcare, Murray

84132

University of Utah, Salt Lake City

85259

Mayo Clinic, Scottsdale

90095

University of California, Los Angeles, Los Angeles

94117

University of California San Francisco, San Francisco

02215

Beth Israel Deaconess Medical Center, Boston

Sponsors

Lead Sponsor

Lipocine Inc.
All Listed Sponsors
lead

Lipocine Inc.

INDUSTRY

NCT04874350 - A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia | Biotech Hunter | Biotech Hunter