NASH - Nonalcoholic Steatohepatitis
Conditions
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.
Interventions
DRUGLPCN 1144
Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).
Sponsors
Lipocine Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who have completed the 38 week study LPCN 1144-18-002 and wish to be treated with LPCN 1144 2. Subject must sign the Informed Consent Form to participate in the study
Exclusion criteria
1. Has participated or is participating in any other clinical (investigational) study after completion of LPCN 1144-18-002 study 2. Subjects who are currently receiving any androgens or estrogens 3. Subjects who are not willing to use adequate contraception for the duration of the study 4. 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 5. Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of LPCN 1144 | Baseline to Week 36 | Number of subjects presenting with a treatment-emergent adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment A LPCN 1144: Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose). | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Treatment A |
|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 25 |
| other Total, other adverse events | 2 / 25 |
| serious Total, serious adverse events | 1 / 25 |
Outcome results
Primary
Safety and Tolerability of LPCN 1144
Number of subjects presenting with a treatment-emergent adverse events
Time frame: Baseline to Week 36
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment A | Safety and Tolerability of LPCN 1144 | 10 Participants |