NCT04874350

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

A Phase 2, Randomized Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Lipocine Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Liver Cirrhosis
• Sarcopenia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-30
• Primary completion: 2023-12-18
• Completion: 2023-12-18
• First posted: 2021-05-05
• Last updated: 2024-03-15

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study