NCT04134091Phase 2Completed

The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2021-06-24Actual

Enrollment · participants56Actual

Source updated2023-12-14Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Nonalcoholic Steatohepatitis (NASH)

Treatments or interventions studied

LPCN 1144 Formulation ADrugAlso known as testosterone undecanoate
LPCN 1144 Formulation BDrugAlso known as testosterone undecanoate with d-alpha tocopherol
PlaceboDrugAlso known as Oral placebo

Primary outcomes · main study measures

measure: Absolute Change in Hepatic Fat Fraction Based on MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo.; description: The change in magnetic resonance imaging derived proton fat fraction (MRI-PDFF) from baseline to week 12 in LPCN 1144 treated subjects and subjects given placebo.; timeFrame: Baseline and Week 12

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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