Professor of Medicine
Campus mail:
03119 Hosp South, Suite 03107, Room 03125, Durham, NC 27710
Phone:
(919) 684-3262
My research interests include metabolic liver disease, particularly obesity-related liver disease and its association with complications of the insulin resistance syndrome. I am interested in studying the clinical, environmental, and genetic risk factors for nonalcoholic fatty liver disease, new therapeutic options for treatment, and evaluating the impact of NAFLD from a public health perspective.
Education and Training
- University of Missouri Kansas City, School of Medicine, M.D. 1992
- Mayo School of Health Sciences, Medical Resident, Medicine
- Mayo School of Health Sciences, Fellow in Gastroenterology, Medicine
Selected Grants and Awards
- Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (ALPINE 4)
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH
- TERN101-201 - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered TERN-101 Tablets in Adult Patients
- A multidisciplinary study of biological disparities in NASH progression and response to statins to inform personalized liver cancer chemoprevention in NAFLD
- A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation
- Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN)
- A 52-Week, Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients with Non-alcoholic Fatty Liver Disease (NAFLD) (MAESTRO-NAFLD-1)
- ARMOR
- Celgene CC-90001 NASH-001
- Investigation of efficacy and safety of semaglutide s.c. once-weekly versus placebo in subjects with non-alcoholic steatohepatitis and compensated liver cirrhosis
- Duke CTSA (TL1)
- VK2809 A Phase 2b Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 52 Weeks Followed by a 4-Week Off-Drug Phase in Subjects with Biopsy Proven Non-Alcoholic
- A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver or Nonalcoholic Steatohepatitis.
- Is Heart Failure with Preserved Edection Fraction the Symptomatic Manifestation of Liver Disease
- A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacodynamic Effects of MEDI0382 in Obese Subjects with Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH)
- Intercept 747-303 - A phase 3 double-blind, randomized, long-term, placebo-controlled, multicenter study evaluating the safety and efficacy of Obeticholic acid in subjects with Nonalcoholic Steatohepatitis.
- Genentech GC41003
- A Randomized, Open-label, Phase 1b Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Signals of DUR-928 in Patients with Non-Alcoholic Steatohepatitis (NASH)
- A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in adults with nonalcoholic steatohepatitis (NASH) and Compensated Liver Cirrhosis
- A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in adults with nonalcoholic steatohepatitis (NASH) and Stage 3 liver fibrosis
- Inventiva IVA337
- NGM282 18-0108
- A Phase 2a, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess the Safety, Tolerability,
Pharmacokinetics, and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis - Genfit GFT505-315-1 NASH - A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy adn Safety of Elafibranor in Patients with Nonalcoholic Steatohepatitis (NASH) and fibrosis.
- A randomized, double-blind, placebo-controlled, parallel group trial to assess the efficacy and safety of PXL770
versus placebo after 12 weeks of treatment in patients with Nonalcoholic Fatty Liver Disease (NAFLD) with or without type 2 diabetes - Novartis LJC242A2201J
- A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis
- Ancillary Studies of NAFLD and NASH in HIV infected Adults
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis
- Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis (NASH)
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
- Progenity PRO-121-NAFLD - EVALUATION OF THE SIGNIFICANCE OF CELL FREE DNA AND EPIGENETIC MARKERS AS PREDICTIVE FACTORS FOR NONALCOHOLIC FATTY LIVER DISEASE (NAFLD)
- A Phase 2 Dose Ranging, Randomized Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Non-Alcoholic Steatohepatitis (NASH) EDP 305-101
- Gilead 454-4378 A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects with Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) due to NASH
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis
- Galectin GI-026 A Multi-Center, Randomized, Controlled, Double-blind, Parallel Group, Phase 2/3 Clinical Trial to Evaluate the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients with NASH
- Genetic and Epigenetic Markers of Progressive Nonalcoholic Fatty Liver Disease
- Gilead 384-1497 A Phase 2, Randomized, Open Label Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 alone or in Combination with Simtuzumab (SIM) in Subjects with Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3.
- A multi-centre, double-blind, parallel-group, randomised, placebo controlled phase II a study to
investigate safety, tolerability, pharmacodynamics, and pharmacokinetics of different doses of
orally administered BI 1467335 - Conatus IDN 6556-14 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Porta
- TOBIRA 652-2-203
- Madrigal MGL-3196-05 A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 in Patients with Non-alcoholic Steatohepatitis
- Conatus IDN-6556-12 A Multicenter, Randomized, Double-Blind, Placebo controlled
Trial of Emricasan (IDN-6556), an Oral Caspase Inhibitor, in Subjects with Non-alcoholic Steatohepatitis
(NASH) Fibrosis - A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for 12 Weeks in Patients with Histologically Confirmed Nonalcoholic Steatohepatit
- BMS MB130-045
- Immuron IMM-124E
A phase II, randomized, double-blind, placebo-controlled study of IMM-124E for patients with non-alcoholic steatohepatitis. - Shire SHP626-201...A Phase 2 Double-Blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability and Efficacy of Volixibat Potassium, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi) in Adults with
- Gilead 402-1852 A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS 9674 in Subjects with Nonalcoholic Steatohepatitis (NASH)
- GILEAD 426-3989 A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects with Nonalcoholic Steatohepatitis
- A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis with Fibrosis
- A Phase IIb, double blind randomized, controlled clinical trial, to evaluate the efficacy and safety of two aramchol doses versus placebo in patients with Non-Alcoholic Steatohepatitis (NASH)
- Intercept 747-209 A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study
Investigating the Effects of Obeticholic Acid and Atorvastatin Treatment on
Lipoprotein Metabolism in Subjects with Nonalcoholic Steatohepatitis - Cirius EMMINENCE
- Exalenz - CSPH-EX-0414 Clinical Study of the BreathID® LF System to train the algorithm for the ¹³C-Methacetin Breath Test (MBT) in assessment of Portal Hypertension in Patients with Compensated Liver Cirrhosis
- To evaluate how protease expression changes throughout the course of NASH.
- Acoustic Radiation Force Based Hepatic Elasticity Quantification and Imaging
- ARI-3037MO-006 A RANDOMIZED, DOUBLE-BLIND, EXPLORATORY PHASE 2 STUDY TO ASSESS THE EFFECTS OF ARI¿3037MO ON HEPATIC FAT METABOLISM IN PATIENTS WITH DYSGLYCEMIA AND EVIDENCE OF HEPATIC STEATOSIS WITH NONALCOHOLIC FATTY LIVER DISEASE OR NONALCOHOLIC ST
- Impact of Fructose on Metabolism, Energy Homeostasis and MR biomarkers in NAFLD
- Synageva BioPharma LAL-CSS01
A STUDY TO IDENTIFY THE FREQUENCY OF LYSOSOMAL ACID LIPASE DEFICIENCY IN AT-RISK PATIENT POPULATIONS - Development and clinical validation of a clinical diagnostic/prognostic laboratory test for liver disease
- Characterizing Alcohol's Effects on Repair of Liver Injury
- Hyperinsulimia and Insulin Resistance in Nonalcoholic Fatty Liver Disease