The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis
NASH
A Phase 2, Randomized Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis (NASH)
1 other identifier
interventional
56
1 country
19
Brief Summary
This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2019
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2019
CompletedStudy Start
First participant enrolled
August 27, 2019
CompletedFirst Posted
Study publicly available on registry
October 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2021
CompletedResults Posted
Study results publicly available
December 14, 2023
CompletedDecember 14, 2023
December 1, 2023
1.8 years
August 16, 2019
August 14, 2023
December 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute Change in Hepatic Fat Fraction Based on MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo.
The change in magnetic resonance imaging derived proton fat fraction (MRI-PDFF) from baseline to week 12 in LPCN 1144 treated subjects and subjects given placebo.
Baseline and Week 12
Secondary Outcomes (12)
Relative Change in MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo.
Baseline and week 12
Number of Participants With Resolution of NASH on Overall Histopathological Reading in LPCN 1144 Treated Subjects Compared to Placebo
Baseline and Week 36
Number of Subjects Achieving Resolution of NASH on Overall Histopathological Reading and no Worsening of Liver Fibrosis in LPCN 1144 Treated Subjects Compared to Placebo.
Baseline and Week 36
Number of Subjects With Improvement in NASH Evaluated by Paired Biopsies Analysis and no Worsening of Liver Fibrosis in LPCN 1144 Treated Subjects Compared to Placebo.
Baseline and week 36
Change in the Mean Score of NAS Components at Baseline and After 36 Weeks of Treatment in LPCN 1144 Treated Subjects Compared to Placebo.
Baseline and Week 36
- +7 more secondary outcomes
Study Arms (3)
Treatment A
EXPERIMENTALLPCN 1144 Formulation A
Treatment B
EXPERIMENTALLPCN 1144 Formulation B
Treatment C
PLACEBO COMPARATORPlacebo
Interventions
Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as 225 mg testosterone undecanoate twice daily (BID).
Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as 225 mg testosterone undecanoate + 238 mg d-alpha tocopherol BID
Eligibility Criteria
You may qualify if:
- Male between 18 and 80 years of age, inclusive.
- Subject with histologic evidence of NASH upon central read of a liver biopsy.
- i. A historical biopsy no more than 4 months before Screening may be considered for use with medical monitor approval if the following criteria are met:
- Stable weights between the time of the biopsy and Screening. Stable weight is defined as no more than a 5% change.
- Is either not taking or is on a stable dose of Thiazolidinedione(TZDs)/glitazones for 3 months before Day 1.
- Background therapy for other ongoing chronic conditions, and weight should be stable for at least 3 months before trial enrollment. Stable weight is defined as no more than a 5% change.
- Judged to be in good general health as determined by the investigator at screening.
You may not qualify if:
- Significant alcohol consumption more than 30 g/day on average, either currently or for a period of more than 3 consecutive months in the 5 years prior to screening.
- Inability to reliably quantify alcohol intake.
- Biochemical, clinical or histologic evidence of cirrhosis on liver biopsy (stage 4 fibrosis).
- Evidence of other causes of chronic liver disease including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus, etc.
- Suspected or proven liver cancer.
- Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
- Hematocrit \> upper limits of normal (ULN)
- Hemoglobin \> ULN
- Prostate-specific antigen (PSA) \> 4 ng/mL
- Serum aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 200 IU/L
- Serum alkaline phosphatase (ALP) \> 2 x ULN
- Serum creatinine of 2.0 mg/dL or greater
- Total bilirubin \> ULN
- International normalized ratio (INR) ≥ 1.3.
- Prolactin \> ULN
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lipocine Inc.lead
Study Sites (19)
TriWest Research Associates, LLC
El Cajon, California, 92020, United States
United Medical Doctors
Murrieta, California, 92563, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
Clinical Trials Research
Roseville, California, 95661, United States
Meridien Research-Maitland
Maitland, Florida, 32751, United States
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014, United States
Sensible Healthcare, LLC
Ocoee, Florida, 34761, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, 89106, United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121, United States
Awasty Research Network
Marion, Ohio, 43302, United States
R&H Clinical Research
Katy, Texas, 77494, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Endeavor Clinical Trials
San Antonio, Texas, 78229, United States
Clinical Trial Network-Houston
Spring, Texas, 77386, United States
Pioneer Research Soultions
Sugar Land, Texas, 77479, United States
Advanced Clinical Research - Gut Whisperer
Riverton, Utah, 84065, United States
Granger Medical Clinic
West Valley City, Utah, 84120, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director of Clinical Development
- Organization
- Lipocine Inc
Study Officials
- STUDY DIRECTOR
Anthony DelConte
Lipocine Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Subjects meeting the enrollment criteria will be randomly assigned to one of the three treatment arms. The randomization will be carried out by central assignment. The study is a blinded study; therefore all the randomization codes will be centrally maintained and no data from the randomization will be available to Sponsor, contract research organization (CRO) operations team, medical monitors, monitors or any site staff.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2019
First Posted
October 21, 2019
Study Start
August 27, 2019
Primary Completion
June 24, 2021
Study Completion
June 24, 2021
Last Updated
December 14, 2023
Results First Posted
December 14, 2023
Record last verified: 2023-12