Phase 2
Completed N=25
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
NASH - Nonalcoholic Steatohepatitis
Source: ClinicalTrials.gov NCT04685993 ↗
Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Jul 2024
Primary outcomePrimary: Safety and Tolerability of LPCN 1144 — 10 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of LPCN 1144 |
10 | — |
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
Data sourced from ClinicalTrials.gov (NCT04685993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.