Open Clinical Trials

This study tests a novel FXR agonist, INT-787, as a treatment for those with severe alcohol-associated hepatitis. This is a Phase 2a,  proof-of-concept study to evaluate the safety, tolerability, efficacy, and PK of INT-787 in participants with severe alcohol-associated hepatitis who require hospitalization.

Subjects must meet the following criteria to be eligible for study participation:

Inclusion Criteria

    1. Males or females aged 18 to 65 years (inclusive)

    2. Clinical diagnosis of sAH based on all the following:

 a. History of ongoing excess alcohol (>60 g/day [male] or >40 g/day [female]) use for ≥6 months, with <60 days of abstinence prior to the onset of jaundice

b. Serum total bilirubin >3.0 mg/dL

c. AST ≥50 U/L

 d. AST/ALT ratio ≥1.5

e. Onset of jaundice within prior 8 weeks

f. Maddrey Score > 32

g. MELD score ≥21 to ≤30

Selected Exclusion Criteria

• Patients taking >2 doses of systemic corticosteroids within 30 days prior to randomization
• Abstinence from alcohol consumption for >2 months before Day 1
• AST or ALT >400 U/L
• Kidney injury defined as a serum creatinine >1.5 mg/dL or the requirement for renal replacement therapy whether prior to or after study screening
  
   

Study Coordinator:
Vyvian Ngo
650-498-9125 
vyviann@stanford.edu

PI: Dr Aparna Goel: goela21@stanford.edu

Metabolic dysfunction-associated steatotic liver disease is the most common liver disease worldwide. Present in approximately 25% of the United States population, these individuals are at risk for progressive liver disease and the development of metabolic dysfunction-associated steatohepatitis (MASH) that can lead to progressive fibrosis and cirrhosis. This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of of the FGF-21 analogue efruxifermin in subjects with noncirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).  

Inclusion

Males and non-pregnant, non-lactating females between 18–80  years of age, 

Previous history or presence of T2D (as determined by medical history or based on screening lab values if previously undiagnosed [i.e., HbA1c ≥ 6.5%]) or 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose).

Body mass index (BMI) ≥ 25.0 kg/m2. 4

Screening visit: a. FibroScan® liver stiffness measurement (LSM) > 8.5 kPa; b. Enhanced Liver Fibrosis (ELF) score ≥ 9.8; c. Aspartate aminotransfer4. ase (AST) > 35 U/L at Screening;

Estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1. at Screening; b. Hemoglobin A1c (HbA1c) ≤ 9.5% at Screening;

 Total bilirubin < 1.3 mg/dL at Screening and Pre-baseline and direct bilirubin ≤ 0.5 mg/dL at Screening.

 Platelet count ≥ 100,000/μL at Screening; g. Triglyceride (TG) level ≤ 500 mg/dL at Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least 1 point in each of the following components: 1. Steatosis (scored 0 to 3), 2. Ballooning degeneration (scored 0 to 2), and 3. Lobular inflammation (scored 0 to 3) b. Cohort 2: Biopsy-proven fibrosis stage 3. Subjects with NAS <4 may be enrolled and are not required to meet 1 point in each of the components of NAS.

Study Coordinator:  
Jennifer Smart 
650-721-8517 
jsmart2@stanford.edu

PI: Dr Paul Kwo: pkwo@stanford.edu

Inclusion Criteria

 1. Eligible disease(s)/stage(s): esophageal cancer, Barrett’s, gastric intestinal metaplasia, gastric cancer, colon cancer and healthy controls

2. Age greater than 18 years

3. Undergoing endoscopic procedure

4. Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria

Potential study participants must NOT MEET any of the following criteria:

1. Secondary malignancy except nonmelanomatous skin cancer

2. Pregnant or breastfeeding women

3. Liver cirrhosis

4. End-stage renal disease

5. History of chronic lung disease requiring supplemental oxygen

Study Coordinator:  
Maya Ryan
650-721-2741
mayaryan@stanford.edu

PI: Dr. David Goldenberg : degold@stanford.edu

Subjects must meet the following criteria to be eligible for study participation:

• Adults with ulcerative colitis or Crohn’s disease in clinical remission on stable therapy for ≥3 months
• BMI ≥30 and plan to start semaglutide (Wegovy/Ozempic) or tirzepatide as part of standard of care
• HbA1c <7% and not on therapy for type 2 diabetes

Key exclusion criteria include:

• Contraindications to GLP-1RAs or prior use at maximal dose within the last year
• Active perianal disease requiring treatment
• IBD-related surgery within 6 months
• Use of systemic steroids or antibiotics, active oncologic disease, or pregnancy
• Nutritional therapy (oral, enteral, or parenteral) or known gallstones

Study Coordinator:
Maya Ryan
650-721-2741
mayaryan@stanford.edu

PI:  Dr. Stephan Rogalla srogalla@stanford.edu and Dr. Yoni Rubin yrubin@stanford.edu