Fatty Liver Disease (NAFLD/NASH) - High Point Clinical Trials Center
 

Fatty Liver Disease (NAFLD/NASH)

Fatty liver disease, specifically nonalcoholic steatohepatitis (NASH), is poised to become the leading cause of liver transplants by 2020.

 

Our Founder Dr. Adnan Mjalli, established our facility in 2008 to conduct early stage clinical pharmacology and Proof of Concept studies in Patient populations. Our long history of diabetes and obesity research makes us a Research Destination and a premier facility ideally suited to qualify, enroll and execute studies involving Patients with NAFLD and NASH..

ENHANCED PATIENT ACCESS

  • 15,000+ Patients with metabolic disease, obesity, and elevated liver enzymes
  • Proactive pre-screening initiatives collecting relevant Patient data: medical history, blood chemistry, CAP scores with Fibroscan, eGFR values and others
  • In-house recruitment team supported by mobile recruitment unit
  • Data-driven outreach targeting new and pre-screened Patients based on demographic selectors and I/E criteria
  • Consistent community outreach and medical volunteering efforts

EARLY STAGE POC EXPERIENCE

  • Patient-centric clinical facility with 24/7 medical oversight
  • Extensive Clinical Pharmacology and POC study experience
  • 40+ metabolic disorder studies
  • PK/PD, Efficacy, and Safety
  • SAD/MAD and POC Adaptive Designs
  • Wide range of ROA capabilities

TECHNICAL
SPECIALTIES

  • In-house Fibroscan Screening & Diagnosis
  • MRI and CAP score confirmed Patients
  • Strategic alliances for Metabolomics, Biomarker and Clinical Endpoint Assays

CASE STUDIES

Phase 2 Safety, Tolerability, Pharmacokinetics and Efficacy Study in Patients With NASH

 

2-Week Study In Patients With Nonalcoholic Fatty Liver Disease

RELEVANT MATERIAL

Pathway for NAFLD and NASH drug development in early phase clinical trials

Clinical Assessment of Hepatic de Novo Lipogenesis in NAFLD

“NAFLD can be a life-threatening condition with no currently approved therapy that is often undiagnosed. Our goal is to bring awareness to both the disease and opportunity for Patients to participate in promising clinical research studies”

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