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NCT04685993 · ClinicalTrials.gov registry record · Phase 2

A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial

A Phase 2 study of NASH - Nonalcoholic Steatohepatitis, sponsored by Lipocine.

Completed
Registry status
Phase 2
Development phase
25
Enrollment target
10
Study locations

NCT04685993 is a Phase 2 study of NASH - Nonalcoholic Steatohepatitis that has completed, run by Lipocine. The registered enrollment target is 25 participants, below the 268-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (91% lower). The trial reports 10 study locations across 6 states.

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The verdict

NCT04685993, a Phase 2 study of NASH - Nonalcoholic Steatohepatitis, has completed, sponsored by Lipocine.

COMPLETED
Registry status
Phase 2
Development phase
25 participants
Enrollment target
10
Study locations

Study Summary

This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.

Interventions

  • DRUG LPCN 1144

Study Locations (10)

Texas

  • R&H Clinical Research - Katy
  • Sun Research Institute - San Antonio
  • Endeavor Clinical Trials - San Antonio
  • Pioneer Research Soultions - Sugar Land

Utah

  • Advanced Clinical Research - Gut Whisperer - Riverton
  • Granger Medical Clinic - West Valley City

California

  • Clinical Trials Research - Roseville

Florida

  • Sensible Healthcare, LLC - Ocoee

Nevada

  • Jubilee Clinical Research, Inc. - Las Vegas

Virginia

  • Manassas Clinical Research Center - Manassas

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2020-11-11
Est. Completion 2022-03-01
Phase Phase 2

Sponsor

Lipocine

5 total trials

What the Registry Record Tells You About NCT04685993

The ClinicalTrials.gov registry entry for NCT04685993 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 268-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (91% lower). The listed sponsor is Lipocine, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 1 intervention - of which LPCN 1144 is the first listed.

NCT04685993 reports 10 study locations spanning 6 distinct geographic areas - top geographies include Texas, Utah, California.

Frequently Asked Questions

What is clinical trial NCT04685993 about?

NCT04685993 is a clinical study titled "A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial". This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.

What is the current status of trial NCT04685993?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2020-11-11. Estimated completion is 2022-03-01.

What conditions does trial NCT04685993 study?

This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis.

What interventions are being tested in trial NCT04685993?

The interventions under investigation include: LPCN 1144 (DRUG).

Who is sponsoring clinical trial NCT04685993?

This trial is sponsored by Lipocine, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04685993 being conducted?

This trial has 10 study locations across California, Florida, Nevada, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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