Clinical Trial Details

Trial ID: L0223
Source ID: NCT04134091
Associated Drug: LPCN 1144
Title: A Study to Assess the Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis (NASH)
Acronym: --
Status: Completed
Study Results: No Results Available
Results: --
Conditions: Nonalcoholic Steatohepatitis (NASH)
Interventions: Drug: LPCN 1144 Formulation A|Drug: LPCN 1144 Formulation B|Drug: Placebo
Outcome Measures: Change in hepatic fat fraction based on MRI-PDFF measurements in LPCN 1144 treated subjects compared to placebo.|Change in NASH activity evaluated via a standardized scoring of liver biopsies at baseline and after 36 weeks of treatment in LPCN 1144 treated subjects compared to placebo.|Relative change in hepatic fat fraction based on MRI-PDFF measurements in LPCN 1144 treated subjects compared to placebo.|NAFLD resolution of subjects who at baseline are at least 5% with a decrease to less than 5% at end of study in LPCN 1144 treated subjects compared to placebo.|Resolution of NASH on overall histopathological reading in LPCN 1144 treated subjects compared to placebo. Resolution of NASH is defined as NAS score of 0-1 for inflammation, 0 for ballooning, and any value for steatosis.|Resolution of NASH on overall histopathological reading and no worsening of liver fibrosis on NASH CRN fibrosis score in LPCN 1144 treated subjects compared to placebo..|Change in fibrosis score via NASH Clinical Research Network fibrosis score (0-4) of liver biopsies in LPCN 1144 treated subjects compared to placebo.|Improvement in liver fibrosis greater than or equal to one stage (NASH Clinical Research Network fibrosis score, 0-4) in LPCN 1144 treated subjects compared to placebo..|Improvement in liver fibrosis greater than or equal to one stage (NASH Clinical Research Network fibrosis score, 0-4) and no worsening of NASH (defined as no increase in NAFLD Activity Score (0-8)) in LPCN 1144 treated subjects compared to placebo.|Change in insulin resistance (assessed by Homeostasis Model Assessment (HOMA)) in LPCN 1144 treated subjects compared to placebo.|Changes in liver enzymes aspartate transaminase (AST), (alanine transaminase (ALT), alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT), Total Bilirubin (TB) and Creatine Kinase (CK) in LPCN 1144 treated subjects compared to placebo.|Changes in non-invasive markers of fibrosis and steatosis in LPCN 1144 treated subjects compared to placebo.|Changes in serum lipid profile parameters (LDL, HDL, and triglycerides) in LPCN 1144 treated subjects compared to placebo.|Changes in Functional Activity (NHANES Physical Activity and Physical Fitness - PAQ, 2017) in LPCN 1144 treated subjects compared to placebo.|Changes in weight (kg) in LPCN 1144 treated subjects compared to placebo.|Changes in body mass index (BMI) in LPCN 1144 treated subjects compared to placebo.|Changes in waist circumference (cm) in LPCN 1144 treated subjects compared to placebo.|Changes in waist to hip ratio (each measured in cm) in LPCN 1144 treated subjects compared to placebo.|Changes in measurements of triceps skin fold thickness (mm) and upper arm circumference (mm) in LPCN 1144 treated subjects compared to placebo.
Sponsor/Collaborators: Lipocine Inc.
Gender: Male
Age: 18 Years to 80 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 56
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: August 27, 2019
Completion Date: June 24, 2021
Results First Posted: --
Last Update Posted: February 25, 2022
Locations: TriWest Research Associates, LLC, El Cajon, California, United States|United Medical Doctors, Murrieta, California, United States|Conquest Clinical Research, Orange, California, United States|Inland Empire Liver Foundation, Rialto, California, United States|Clinical Trials Research, Roseville, California, United States|Meridien Research-Maitland, Maitland, Florida, United States|Clinical Pharmacology of Miami, LLC, Miami, Florida, United States|Sensible Healthcare, LLC, Ocoee, Florida, United States|University of Chicago, Chicago, Illinois, United States|Tandem Clinical Research, Marrero, Louisiana, United States|Jubilee Clinical Research, Inc., Las Vegas, Nevada, United States|Clinical Research of South Nevada, Las Vegas, Nevada, United States|Awasty Research Network, Marion, Ohio, United States|R&H Clinical Research, Katy, Texas, United States|Sun Research Institute, San Antonio, Texas, United States|Endeavor Clinical Trials, San Antonio, Texas, United States|Clinical Trial Network-Houston, Spring, Texas, United States|Pioneer Research Soultions, Sugar Land, Texas, United States|Advanced Clinical Research - Gut Whisperer, Riverton, Utah, United States|Granger Medical Clinic, West Valley City, Utah, United States|Manassas Clinical Research Center, Manassas, Virginia, United States
URL: https://ClinicalTrials.gov/show/NCT04134091

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D211 LPCN 1144 Biological drug -- AR activator Metabolic disorder drug Under clinical trials Details
D094 Cysteamine Chemical drug DB00847 GSS stimulant Renal drug Under clinical trials Details
D095 Cysteamine bitartrate Chemical drug DB00847 -- -- Under clinical trials Details
D182 Insulin Biological drug DB00030 INSR agonist; CPE modulator&product of -- Under clinical trials Details
D199 L-alanine Chemical drug DB00160 KYNU -- Failed in clinical trials Details
D316 S-adenosyl-L-methionine Chemical drug DB00118 GNMT cofactor Antiviral Under clinical trials Details
D328 Serine Chemical drug DB00133 SRR Improve insulin resistance Under clinical trials Details
D545 Pig placenta extract Biological extract -- -- -- Under clinical trials Details