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.
This is a 52-week, multicenter, double-blind, placebo-controlled, two arm study of LPCN 1148 in adult men with cirrhosis of the liver and sarcopenia on the liver transplant waitlist. This study will evaluate the efficacy, safety, and tolerability of LPCN 1148, determined through a range of clinical outcomes and functional and laboratory tests. Approximately 48 subjects will be randomized 1:1 ratio to receive one of the following treatments: * Treatment A: Oral LPCN 1148 * Treatment B: Oral matching placebo. Subjects will undergo a screening period to determine study eligibility. Adult male subjects with liver cirrhosis and sarcopenia on the transplant list will be enrolled into the study. There are two treatment phases to this study. * Stage 1: 24 weeks of blinded study treatment (LPCN 1148 or matching placebo) * Stage 2: 28-week open-label extension. Subjects who participate in Stage 1 of this trial will roll over to a 28-week open-label extension phase. All subjects will receive LPCN 1148; there will be no placebo in the extension period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
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
Change from baseline in Skeletal Muscle Index in LPCN 1148 treated subjects compared to placebo
Time frame: 24 weeks
Change from baseline in Liver Frailty Index in LPCN 1148 treated subjects compared to placebo
Time frame: 24 weeks
Change in number of breakthrough hepatic encephalopathy events in LPCN 1148 treated subjects compared to placebo
Breakthrough hepatic encephalopathy was defined as events of hepatic encephalopathy with a Common Terminology Criteria for Adverse Events grade greater than grade 1
Time frame: 24 weeks
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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