Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04874350
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2021-05-03
Brief Title:
A Study to Assess the Efficacy Safety and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia
Sponsor:
Lipocine Inc
Organization:
Lipocine Inc
Study Overview
Official Title:
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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 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
Approximately 48 subjects will be randomized 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None