Past & Current Clinical Trials – Evidentis Research

Evidentis Clinical Research is led by a principal investigator with extensive experience conducting multi-center, investigator-led and industry-sponsored clinical trials at UT Southwestern and collaborating institutions. This background informs the operational standards, scientific rigor and participant-centered approach used at Evidentis today.

Below is a selection of notable trials led or supported by our investigator prior to Evidentis.

Study Information	Phase / Sponsor	Role	Highlights / NCT Number
INT-787 in alcohol-associated hepatitis (FRESH)	Phase 2a / Intercept	Principal Investigator	Second-highest enroller worldwide; intensive PK sampling; no major protocol deviations NCT05639543
DUR-928 in alcohol-associated hepatitis (AHFIRM)	Phase 2b / DURECT	Co-Investigator	High-enrolling site; strong protocol adherence; no major protocol deviations NCT04563026
Anakinra in alcohol-associated hepatitis (Alc-Hep-Net Multicenter)	Phase 2b / NIH	Steering Committee; Co-Investigator	Highest enroller in the U.S.; contributed to national protocol refinement NCT04072822
GSK4532990 in alcohol-related liver disease (STARLIGHT)	Phase 2 / GlaxoSmithKline	Co-Investigator	Strong early enrollment pipeline; recognized for efficient study ramp-up NCT0661369
Pemvidutide in alcohol-related liver disease (RESTORE)	Phase 2 / Altimmune	Co-Investigator	Early startup performance recognized by sponsor NCT07009860
IL-22 and acamprosate in alcohol-associated hepatitis and alcohol use disorder (ITAALD Multicenter)	Phase 2 / NIH	Steering Committee; Co-Investigator	Active role in multicenter coordination; strong site-level feasibility and enrollment setup NCT07060638
Natural history of alcohol-associated liver disease — The Dallas Dionysus Study	Observational / Investigator-led / NIH	Principal Investigator	Enrolled >100 participants across a multi-site translational program; advanced biospecimen workflows K23AA031310
Additional Trials (Phase 2–4)	Various	Co-Investigator	Broad experience with early- and late-phase therapeutics across liver, metabolic, and immunologic pathways

This track record demonstrates the depth of clinical research experience informing Evidentis operations:

controlled research environment for protocol-directed assessments

timed sampling workflows for intensive PK schedules

overnight observation capability for extended PK windows

participant monitoring area for timed procedures

dedicated phlebotomy and sample-processing space

This setup enables precise execution of 24-48 hour PK sampling and early-phase procedures in a controlled, participant-centered environment.