Oral LPCN 1148 improves sarcopenia and hepatic encephalopathy in male patients with cirrhosis: A randomized, placebo-controlled phase 2 trial.
Bruno, B. J., et al.Hepatology 2025 [record in progress].
Aims
This study aimed to examine the effect of LPCN1148 in male patients with sarcopenia and cirrhosis awaiting liver transplant.
Interventions
Participants were randomly assigned to either the LPCN 1148 group or the placebo group.
Participants
32 adult male patients being awaiting liver transplant due to liver cirrhosis.
Outcomes
The primary outcome was change in skeletal muscle index from baseline to 24 weeks. The secondary outcome was the number of overt hepatic encephalopathy (HE) events.
Follow-up
24 weeks from baseline
CET Conclusions
This multicentre, double-blind phase 2 randomised study randomised 29 male patients with sarcopenia and cirrhosis awaiting liver transplant to receive the androgen receptor agonist LCPN 1148 or placebo for 24 weeks. Patients in the study group demonstrated an increase in skeletal muscle index, as well as fewer episodes of hepatic encephalopathy when compared to controls. These are interesting findings that may have implications for the pre-transplant optimisation of patients with sarcopenia and cirrhosis. The study is well designed and conducted. The main limitations are the small sample size, including only of male patients, and a lack of longer-term outcomes including transplant rates and post-transplant outcomes. Future studies should address these limitations.
Data analysis
Modified intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT04874350