testosterone prodrug (LPCN 1148) / Lipocine - LARVOL DELTA

LPCN 1148: Rebuilding muscle memory in cirrhosis patients. (PubMed, Hepatology) - No abstract available

Journal • Fibrosis • Immunology

Reply: Considerations on the use of LPCN 1148 in cirrhotic patients with sarcopenia. (PubMed, Hepatology) - No abstract available

Journal • Liver Cirrhosis • Sarcopenia

Letter to the editor: Considerations on the use of LPCN 1148 in cirrhotic patients with sarcopenia. (PubMed, Hepatology) - No abstract available

Journal • Liver Cirrhosis • Sarcopenia

FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis (PRNewswire) - "Lipocine Inc...announced that the U.S. Food and Drug Administration ('FDA') has granted Fast Track Designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis. LPCN 1148, an oral prodrug of bioidentical testosterone, was recently studied in a proof-of-concept (POC) Phase 2 study in patients with decompensated cirrhosis. Treatment with LPCN 1148 in the POC study improved sarcopenia and associated clinical outcomes."

Fast track • CNS Disorders • Liver Cirrhosis • Sarcopenia

Oral LPCN 1148 improves sarcopenia and hepatic encephalopathy in male patients with cirrhosis: A randomized, placebo-controlled phase 2 trial. (PubMed, Hepatology) - P2 | "LPCN 1148 treatment improved sarcopenia and reduced the number of overt HE episodes in men with cirrhosis and sarcopenia awaiting liver transplant. These findings support additional research on the efficacy of LPCN 1148 in treating sarcopenia and preventing HE recurrence."

Journal • P2 data • CNS Disorders • Fibrosis • Gastroenterology • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis • Sarcopenia • Transplantation • AR

Thanks to @HealioGastro for covering my #EASLCongress presentation on LPCN 1148, an oral androgen receptor agonist, improving sarcopenia in men with advanced cirrhosis as early as week 12 — with sustained improvement through 52 weeks. https://bit.ly/3VVkSvq #livertwitter

Oral androgen receptor agonist improves sarcopenia over 52 weeks in men with cirrhosis (Healio) - "'Sarcopenia is common in cirrhosis and impacts clinically meaningful outcomes,' Arun Sanyal, MD...said during a presentation at EASL Congress. 'There are multiple mechanisms that contribute to sarcopenia in cirrhosis. Of these, several pathways are impacted by androgens....Of note, 90% of males with cirrhosis have low free testosterone.'"

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Intervention with oral LPCN 1148 improves sarcopenia and hepatic encephalopathy (HE) in patients with cirrhosis: a 52-week phase 2 randomized clinical trial (EASL-ILC 2024) - P2 | "Basal T level was not considered for study eligibility and participants were not asked to change diet, exercise, or background therapies including rifaximin or lactulose during the study. LPCN 1148 is the first therapeutic intervention to both improve sarcopenia and reduce overt HE episodes in men with cirrhosis awaiting liver transplant. Furthermore, LPCN 1148 was well- tolerated with up to 52 weeks of therapy. These results provide support for further study of LPCN 1148 for the treatment of sarcopenia and prevention of HE recurrence in advanced cirrhosis."

Clinical • Late-breaking abstract • P2 data • Anemia • Cardiovascular • CNS Disorders • Fibrosis • Hematological Disorders • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis • Liver Failure • Sarcopenia • Thrombosis

LPCN 1148 Achieves Phase 2 Study Endpoints in Cirrhosis Management (HCPLive) - "'The rapid and sustained increases in muscle mass seen in this study with LPCN 1148 are very exciting, especially as there are currently no FDA-approved pharmacotherapeutics for sarcopenia in cirrhosis,' Jennifer Lai, MD...said in a statement."

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A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: Lipocine Inc. | Active, not recruiting ➔ Completed | Trial primary completion date: Jun 2023 ➔ Dec 2023

Trial completion • Trial primary completion date • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis • Sarcopenia

Oral androgen receptor agonist improves sarcopenia, encephalopathy in cirrhosis (Healio) - "'Sarcopenia is commonly present in those with decompensated cirrhosis and impacts clinically meaningful outcomes,' Arun J. Sanyal...'LPCN 1148...improved sarcopenia in adult male patients with cirrhosis,' Sanyal concluded."

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ORAL LPCN 1148 IMPROVES SARCOPENIA AND HEPATIC ENCEPHALOPATHY IN PATIENTS WITH CIRRHOSIS (AASLD 2023) - P2 | "Basal T level was not considered for study eligibility and participants were not asked to change diet, exercise, or background therapies including rifaximin or lactulose. LPCN 1148 is the first therapeutic intervention to both improve sarcopenia and reduce the number of overt HE episodes, in men with cirrhosis awaiting liver transplant. These results provide support for further study of LPCN 1148 for the treatment of sarcopenia and prevention of HE recurrence."

Clinical • Late-breaking abstract • Anemia • Cardiovascular • CNS Disorders • Fibrosis • Gastroenterology • Hematological Disorders • Hepatic Encephalopathy • Hepatocellular Cancer • Hepatology • Immunology • Liver Cirrhosis • Liver Failure • Sarcopenia • Thrombosis • Transplantation

LPCN 1148 Phase 2 Study Meets Primary Endpoint in Patients with Cirrhosis (BioSpace) - "Dr. Arun J. Sanyal, MD...commented, 'Sarcopenia and frailty are major markers of poor outcomes for patients with end-stage liver disease. It is very exciting to see proof of concept that correction of sarcopenia by LPCN 1148 safely improved muscle mass, functional status and quality of life as well as reduced days in the hospital compared to placebo...I look forward to larger studies to further confirm the efficacy and safety of LPCN 1148 that was observed in this study.' Dr. Jennifer Lai, MD, MBA...added, 'All of these patients had advanced liver disease awaiting liver transplant which predisposes them to losing muscle mass. The fact that those who received LPCN 1148 gained muscle mass in a relatively short time is remarkable. The signals toward improved clinical outcomes, such as hospitalized days and rates of hepatic encephalopathy, are scientifically plausible effects of having higher muscle mass and are quite promising.'"

Media quote

A multimodal treatment candidate for sarcopenia in men with decompensated cirrhosis: a randomized, placebo-controlled trial evaluating LPCN 1148 (EASL-ILC 2023) - "There are trends within this sarcopenic, decompensated cirrhotic population indicating dysfunction in other key physiologic areas, including hematologic, thrombotic, androgenic, metabolic, immunity, and frailty. Potentially related to the failing liver and reduced muscular mass, systemic ammonia levels are high in the majority of the study population which predisposes participants to episodes of overt HE."

Clinical • Fibrosis • Hematological Disorders • Hepatic Encephalopathy • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Non-alcoholic Steatohepatitis • Sarcopenia • Transplantation • IGF1

A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Lipocine Inc. | Recruiting ➔ Active, not recruiting | N=48 ➔ 30

Enrollment change • Enrollment closed • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis • Sarcopenia

A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Lipocine Inc. | Trial primary completion date: Sep 2023 ➔ May 2023

Trial primary completion date • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis • Sarcopenia

A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Lipocine Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2021 ➔ Dec 2021

Enrollment open • Trial initiation date • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis • Sarcopenia

A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: Lipocine Inc.

Clinical • New P2 trial • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis • Sarcopenia