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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | LPCN 1144 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPCN 1144 | Drug | Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of LPCN 1144 | Number of subjects presenting with a treatment-emergent adverse events | Baseline to Week 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony DelConte | Lipocine Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Research | Roseville | California | 95661 | United States | ||
| Sensible Healthcare, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A | LPCN 1144: Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered twice daily (225 mg testosterone undecanoate per dose). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2021 |
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| Ocoee |
| Florida |
| 34761 |
| United States |
| Jubilee Clinical Research, Inc. | Las Vegas | Nevada | 89106 | United States |
| R&H Clinical Research | Katy | Texas | 77494 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78229 | United States |
| Pioneer Research Soultions | Sugar Land | Texas | 77479 | United States |
| Advanced Clinical Research - Gut Whisperer | Riverton | Utah | 84065 | United States |
| Granger Medical Clinic | West Valley City | Utah | 84120 | United States |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
Subjects who completed the 38 week study LPCN 1144-18-002 as planned and wanted to continue in this open label extension study
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A | LPCN 1144: Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability of LPCN 1144 | Number of subjects presenting with a treatment-emergent adverse events | Posted | Count of Participants | Participants | Baseline to Week 36 |
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|
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | LPCN 1144: Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose). | 1 | 25 | 1 | 25 | 2 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
After the multicenter publication or twelve months after the completion of the study, whichever occurs first, the PI may itself publish the results of its data from the study. The PI shall provide Sponsor with an advance copy of any proposed publication or oral presentation at least sixty days prior to the planned date of submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director of Clinical Development | Lipocine Inc | 801.994.7383 | admin@lipocine.com |
| Jun 21, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C010792 | testosterone undecanoate |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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