NASH
STUDY SPONSOR: VIKING
PI: Dr. Mary Rinella
COORDINATOR: Jeanne Gottstein, phone 312-694-0264, j-gottstein@northwestern.edu
STUDY TITLE: 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 steatohepatitis with fibrosis.
MOA: VK2809 is being developed for the treatment of NASH. A safe, liver-directed THR-β agonist.
| INCLUSION: |
EXCLUSION: |
- Males or females ≥ 18 years old
- MRI-PDFF fat fraction ≥8% done during screening period
- Liver biopsy NAS score ≥4, Fibrosis 2-3
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- History of significant alcohol consumption
- Weight change > 5% within 6 months prior to liver biopsy
- Type 1 diabetes patients
- History of bariatric surgery or intestinal bypass surgery
- Patients with decompensated diabetes (HbA1c >9.0%)
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STUDY SPONSOR: Enanta
PI: Dr. Mary Rinella
COORDINATOR: Jeanne Gottstein, phone 312-694-0264, j-gottstein@northwestern.edu
STUDY TITLE: A PHASE 2b RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING SAFETY AND EFFICACY OF EDP-305 IN SUBJECTS WITH LIVER-BIOPSY PROVEN NON-ALCOHOLIC STEATOHEPATITIS (NASH) (ARGON-2)
MOA: EDP-305 is a farnesoid X receptor (FXR) agonist being investigated by Enanta Pharmaceuticals, Inc. (Enanta) as a potential treatment for Nonalcoholic Steatohepatitis (NASH) with liver fibrosis.
| INCLUSION: |
EXCLUSION: |
- Males or females ≥ 18 years old
- (NAS) of 4 or greater with a score of at least 1 in each component of the, fibrosis 2-3 on biopsy
|
- History of significant alcohol consumption
- MELD >12
- Subjects with clinically or otherwise documented cardiovascular or cerebrovascular disease including clinically significant anomalies of rhythm or pattern of ECG
- Use of a new fibrate regimen from 3 months prior to Screening
- Patients with decompensated diabetes (HbA1c >9.5%)
|
STUDY SPONSOR: NGM
PI: Dr. Rinella
COORDINATOR: Jeanne 312-694-0264 or Kim 312-694-1293, j-gottstein@northwestern.edu, k-sipich@northwestern.edu
STUDY TITLE: Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Doubleblind, Placebo-controlled, Multi-center Study in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)
MOA: By engaging both FGFR4 and FGFR1c pathways to reduce bile acid toxicity and lipotoxicity, and to improve insulin sensitivity, NGM282 has demonstrated robust anti-steatotic, anti-inflammatory and anti-fibrotic activities in multiple animal models of NASH
| INCLUSION: |
EXCLUSION: |
- Adults from 18 to 75 years
- Total liver fat ≥ 8%, MRI-PDFF
- Liver biopsy NAS score ≥4, Cirrhosis
- Statin use based on the following criteria for statin-naïve or statin-experienced at Screening:
- Statin naïve is defined as no statins within 3 months prior to Screening.
- Statin Experienced is defined as administration of < 50% of the maximal dose of current statin therapy
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- Clinically significant acute or chronic liver disease of an etiology other than NASH
- MELD score > 12
- No evidence of varices on EGD
- Type 1 diabetes patients.
- Any contraindication or inability to obtain an MRI
|
STUDY SPONSOR: MADRIGAL 11
PI: Dr. Mary Rinella
COORDINATOR: Kim Sipich, phone 312-694-1293, k-sipich@northwestern.edu
STUDY TITLE: A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation
MOA: MGL-3196 is being developed for the treatment of NASH and for potential use in hypercholesterolemia/dyslipidemia. A safe, liver-directed THR-β agonist.
| INCLUSION: |
EXCLUSION: |
- Males or females ≥ 18 years old
- MRI-PDFF fat fraction ≥8% done during screening period
- Liver biopsy NAS score ≥4, Fibrosis 2-3
- Estimated glomerular filtration rate (GFR) ≥45
|
- History of significant alcohol consumption.
- Regular use of drugs historically associated with NAFLD, which include, but are not limited, to the following: amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens, anabolic steroids, valproic acid.
- Type 1 diabetes patients
- History of bariatric surgery or intestinal bypass surgery
- Patients with decompensated diabetes (HbA1c >9.0%)
|
STUDY SPONSOR: MADRIGAL 14
PI: Dr. Mary Rinella
COORDINATOR: Kim Sipich, phone 312-694-1293, k-sipich@northwestern.edu
STUDY TITLE: 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)
MOA: MGL-3196 is being developed for the treatment of NASH and for potential use in hypercholesterolemia/dyslipidemia. A safe, liver-directed THR-β agonist.
| INCLUSION: |
EXCLUSION: |
- Males or females ≥ 18 years old
- MRI-PDFF fat fraction ≥8% done during screening period
- Liver biopsy
NAS ≥4, steatosis ≥1, fibrosis stage 0 or 1A/1C with PRO-C3 <14
NAS <4 steatosis ≥1, with fibrosis stage ≤3
NAS ≥4, steatosis ≥1, fibrosis stage ≤3 without ballooning |
- History of significant alcohol consumption
- Regular use of drugs historically associated with NAFLD, which include, but are not limited, to the following: amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens, anabolic steroids, valproic acid
- Type 1 diabetes patients
- History of bariatric surgery or intestinal bypass surgery
- Patients with decompensated diabetes (HbA1c >9.0%)
|
STUDY SPONSOR: Galmed
PI: Dr. Mary Rinella
COORDINATOR: Jeanne Gottstein, phone 312-694-0264, j-gottstein@northwestern.edu
STUDY TITLE: A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects with Nonalcoholic Steatohepatitis (NASH) with Open-Label Part to Evaluate the Safety, PK and Treatment Response Kinetics of Aramchol
MOA: Aramchol is the first in a new pharmacological class of fatty acid-bile acid conjugates (FABACs).
| INCLUSION: |
EXCLUSION: |
- Males or females ≥ 18 years old
- MRI-PDFF fat fraction ≥8% done during screening period
- Liver biopsy
NAS ≥4, steatosis ≥1, fibrosis stage 0 or 1A/1C with PRO-C3 <14
NAS <4 steatosis ≥1, with fibrosis stage ≤3
NAS ≥4, steatosis ≥1, fibrosis stage ≤3 without ballooning |
- History of significant alcohol consumption
- Type 1 diabetes patients
- History of bariatric surgery or intestinal bypass surgery
- Patients with decompensated diabetes (HbA1c >9.0%)
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