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

NCT04685993 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: LPCN 1144-20-002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of LPCN 1144

  Number of subjects presenting with a treatment-emergent adverse events

  Baseline to Week 36

Study Arms (1)

Treatment A

EXPERIMENTAL

LPCN 1144

Drug: LPCN 1144

Interventions

LPCN 1144 DRUG

Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).

Also known as: testosterone undecanoate

Treatment A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have completed the 38 week study LPCN 1144-18-002 and wish to be treated with LPCN 1144
• Subject must sign the Informed Consent Form to participate in the study

You may not qualify if:

• Has participated or is participating in any other clinical (investigational) study after completion of LPCN 1144-18-002 study
• Subjects who are currently receiving any androgens or estrogens
• Subjects who are not willing to use adequate contraception for the duration of the study
• Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 weeks in the 2 years prior to enrollment
• Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study

Sponsors & Collaborators

• Lipocine Inc.: lead

Study Sites (10)

Clinical Trials Research

Roseville, California, 95661, United States

Location

Sensible Healthcare, LLC

Ocoee, Florida, 34761, United States

Location

Jubilee Clinical Research, Inc.

Las Vegas, Nevada, 89106, United States

Location

R&H Clinical Research

Katy, Texas, 77494, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

Pioneer Research Soultions

Sugar Land, Texas, 77479, United States

Location

Advanced Clinical Research - Gut Whisperer

Riverton, Utah, 84065, United States

Location

Granger Medical Clinic

West Valley City, Utah, 84120, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Senior Director of Clinical Development
• Organization: Lipocine Inc

admin@lipocine.com

801.994.7383

Study Officials

• Anthony DelConte

  Lipocine Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 28, 2020
• Study Start: November 11, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 17, 2024
• Results First Posted: July 17, 2024

Record last verified: 2024-03

Locations

US (10)