Back to resultsA Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
Primary Purpose
NASH - Nonalcoholic Steatohepatitis
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LPCN 1144
Sponsored by
About this trial
This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Clinical Trials Research
- Sensible Healthcare, LLC
- Jubilee Clinical Research, Inc.
- R&H Clinical Research
- Sun Research Institute
- Endeavor Clinical Trials
- Pioneer Research Soultions
- Advanced Clinical Research - Gut Whisperer
- Granger Medical Clinic
- Manassas Clinical Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment A
Arm Description
LPCN 1144
Outcomes
Primary Outcome Measures
Measure the safety and tolerability of LPCN 1144 by assessing the number of treatment-related adverse events
Monitor the safety and tolerability of LPCN 1144
Measure the effect of LPCN 1144 on liver injury markers
Monitor the safety and tolerability of LPCN 1144
Measure the effect of LPCN 1144 on serum lipid panels
Monitor the safety and tolerability of LPCN 1144
Measure the effect of LPCN 1144 on hematology panels
Monitor the safety and tolerability of LPCN 1144
Measure the safety and tolerability of LPCN 1144 by assessing changes in patient-reported disease severity using the PGI-S questionnaire
Monitor the safety and tolerability of LPCN 1144
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04685993
Brief Title
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
Official Title
An Open Label Extension Study of the Safety and Tolerability of LPCN 1144 for the Treatment of Subjects With Nonalcoholic Steatohepatitis (NASH) Who Have Completed the LPCN 1144-18-002 Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lipocine Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This is a multicenter, open-label extension protocol to provide LPCN 1144, an investigational drug, to subjects with NASH who have completed the LPCN 1144-18-002 protocol. Enrolled subjects will be given LPCN 1144 for up to 36 weeks. Subjects will be seen periodically to evaluate safety clinical laboratory tests, tolerability of LPCN 1144, adverse events, and overall subject health. Subjects will be given the option of having a liver biopsy performed at Week 36.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Description
LPCN 1144
Intervention Type
Drug
Intervention Name(s)
LPCN 1144
Intervention Description
Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).
Primary Outcome Measure Information:
Title
Measure the safety and tolerability of LPCN 1144 by assessing the number of treatment-related adverse events
Description
Monitor the safety and tolerability of LPCN 1144
Time Frame
Baseline to Week 36
Title
Measure the effect of LPCN 1144 on liver injury markers
Description
Monitor the safety and tolerability of LPCN 1144
Time Frame
Baseline to Week 36
Title
Measure the effect of LPCN 1144 on serum lipid panels
Description
Monitor the safety and tolerability of LPCN 1144
Time Frame
Baseline to Week 36
Title
Measure the effect of LPCN 1144 on hematology panels
Description
Monitor the safety and tolerability of LPCN 1144
Time Frame
Baseline to Week 36
Title
Measure the safety and tolerability of LPCN 1144 by assessing changes in patient-reported disease severity using the PGI-S questionnaire
Description
Monitor the safety and tolerability of LPCN 1144
Time Frame
Baseline to Week 36
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Clinical Trials Research
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Sensible Healthcare, LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Jubilee Clinical Research, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
R&H Clinical Research
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pioneer Research Soultions
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Advanced Clinical Research - Gut Whisperer
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Facility Name
Granger Medical Clinic
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84120
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
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