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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 Oct 20, 2026, 10:53 PM 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 27, 2019 (Actual)
Primary completion
Jun 24, 2021 (Actual)
Completion
Jun 24, 2021 (Actual)
Last update posted
Dec 14, 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 14, 2023 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04134091 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →