NCT04685993 is a Phase 2 clinical trial of LPCN 1144 in NASH - Nonalcoholic Steatohepatitis, sponsored by Lipocine Inc..

Who is sponsoring NCT04685993?

NCT04685993 is sponsored by Lipocine Inc..

What drugs are being tested in NCT04685993?

Interventions in NCT04685993: LPCN 1144.

What condition does NCT04685993 study?

NCT04685993 studies NASH - Nonalcoholic Steatohepatitis.

Is NCT04685993 still recruiting?

NCT04685993 is currently completed. Last updated 17 July 2024.

Are results published for NCT04685993?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-07-17 · How we verify

NCT04685993

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 17 July 2024

What this trial tests

Phase 2 trial testing LPCN 1144 in NASH - Nonalcoholic Steatohepatitis in 25 participants. Completed in 1 March 2022.

Timeline

11 November 2020

Primary endpoint
1 March 2022

1 March 2022

Quick facts

Lead sponsor	Lipocine Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	11 November 2020
Primary completion	1 March 2022
Estimated completion	1 March 2022
Sites	10 locations across United States

Drugs / interventions tested

LPCN 1144 — full drug profile →

Conditions studied

NASH - Nonalcoholic Steatohepatitis — all drugs for NASH - Nonalcoholic Steatohepatitis →

Sponsor

Lipocine Inc. — full company profile →

Who can join

Adults 18 to 80, male only, with NASH - Nonalcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety and Tolerability of LPCN 1144 Primary · Baseline to Week 36

Number of subjects presenting with a treatment-emergent adverse events

Group	Value	95% CI
Treatment A	10

Adverse events — posted to ClinicalTrials.gov

Time frame: 9 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment A

Serious: 1/25 (4%)

Deaths: 1/25

Serious adverse events (1 terms)

Reaction	System	Treatment A
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Treatment A
Upper respiratory infection	Infections and infestations	—

Most-reported serious reactions: Respiratory Failure.

Data from ClinicalTrials.gov NCT04685993 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for NASH - Nonalcoholic Steatohepatitis

Currently open trials in the same condition.

NCT05499949 — The Franciscus Obesity NASH Study · active not recruiting
NCT05023044 — Nonalcoholic Fatty Liver Disease in HIV Database · active not recruiting
NCT04232566 — Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity · recruiting
NCT05165446 — Novel MRE Technique to Assess a Risk Factor for Liver Cancer · active not recruiting
NCT04697810 — Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH) · Phase 2 · recruiting

Other Lipocine Inc. trials

Trials by the same sponsor.

NCT06979544 — A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD · Phase 3 · completed
NCT04874350 — A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver · Phase 2 · completed
NCT04134091 — The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis · Phase 2 · completed
NCT03868059 — Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04685993 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lipocine Inc.
Last refreshed: 17 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04685993.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing