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Completed Phase 2 Interventional Results available

The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis

ClinicalTrials.gov ID: NCT04134091

Public ClinicalTrials.gov record NCT04134091. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 2:13 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04134091
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Lipocine Inc.
Industry
Enrollment
56 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 26, 2019
Primary completion
Jun 23, 2021
Completion
Jun 23, 2021
Last update posted
Dec 13, 2023

2019 – 2021

United States locations

U.S. sites
19
U.S. states
8
U.S. cities
17
Facility City State ZIP Site status
TriWest Research Associates, LLC El Cajon California 92020
United Medical Doctors Murrieta California 92563
Inland Empire Liver Foundation Rialto California 92377
Clinical Trials Research Roseville California 95661
Meridien Research-Maitland Maitland Florida 32751
Clinical Pharmacology of Miami, LLC Miami Florida 33014
Sensible Healthcare, LLC Ocoee Florida 34761
Tandem Clinical Research Marrero Louisiana 70072
Jubilee Clinical Research, Inc. Las Vegas Nevada 89106
Clinical Research of South Nevada Las Vegas Nevada 89121
Awasty Research Network Marion Ohio 43302
R&H Clinical Research Katy Texas 77494
Sun Research Institute San Antonio Texas 78215
Endeavor Clinical Trials San Antonio Texas 78229
Clinical Trial Network-Houston Spring Texas 77386
Pioneer Research Soultions Sugar Land Texas 77479
Advanced Clinical Research - Gut Whisperer Riverton Utah 84065
Granger Medical Clinic West Valley City Utah 84120
Manassas Clinical Research Center Manassas Virginia 20110

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04134091, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 13, 2023 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04134091 live on ClinicalTrials.gov.

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