LPCN 1148 for Liver Cirrhosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Liver Cirrhosis+2 More
LPCN 1148 - Drug
Eligibility
18+
Male
What conditions do you have?
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Study Summary

This trial will test whether LPCN 1148 is safe and effective in treating men with cirrhosis and sarcopenia.

Eligible Conditions
  • Liver Cirrhosis
  • Sarcopenia

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 52 weeks

24 weeks
Change from baseline in Skeletal Muscle Index in LPCN 1148 treated subjects compared to placebo
Up to 52 weeks
Change from baseline in Liver Frailty Index in LPCN 1148 treated subjects compared to placebo
Change in number of waitlist events in LPCN 1148 treated subjects compared to placebo

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

LPCN 1148
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: LPCN 1148 · Has Placebo Group · Phase 2

LPCN 1148
Drug
Experimental Group · 1 Intervention: LPCN 1148 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 52 weeks

Who is running the clinical trial?

Lipocine Inc.Lead Sponsor
6 Previous Clinical Trials
724 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: October 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.