CURRENT GASTROENTEROLOGY CLINICAL TRIALS
 

Madrigal: A phase 3 study of MGL-3196 (Resmetirom) in patients with NASH stages 1,2,3 to resolve NASH and reduce progression to cirrhosis and/or hepatic decompensation.
Inclusion Criteria:
• Biopsy-proven NASH (Baseline liver biopsy) based on a liver biopsy obtained within 24 weeks before anticipated date of randomization) with fibrosis stage 1A, 1B, 2, or 3
Exclusion Criteria:
• Hep B, Hep C, HIV, Cirrhosis, Clinically significant cardiovascular disease & several screening labs

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Madrigal: A phase 3 study to evaluate safety and biomarkers of MGL-3196 (Resmetirom) in patients with NAFLD (open label arm for cirrhotic patients open to limited number of participants).
Inclusion Criteria: (EXTENSIVE, here are a few)
• Diagnosis of NAFLD suggested by historical data (Fibroscan >5.5, MRE >2.0 or MRI-PDFF >8%)
Exclusion Criteria: (EXTENSIVE, here are a few)
• Hep B, Hep C, HIV, Cirrhosis, Clinically significant cardiovascular disease & several screening labs

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Madrigal: A 52-week, phase 3 open-label extension study, with a single-blind lead-in, to evaluate safety and biomarkers of MGL-3196 (Resmetirom) in patients with NAFLD, MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE).
Inclusion Criteria:
• Must have participated in MGL-3196-14, completed the week 52 visit, and completed the week 56 visit within 90 days of the extension day 1 visit, and are willing to participate in the extension study

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VIKING: A phase 2b study to evaluate the efficacy, tolerability and safety of VK2809 in patients with NASH with fibrosis.
Inclusion Criteria: (EXTENSIVE, here are a few)
• Histologically confirmed diagnosis of NASH with fibrosis stage 1 to stage 3 and NAS score of > 4
• MRI-PDFF with > 8% liver fat fraction
Exclusion Criteria: (EXTENSIVE, here are a few)
• Have evidence of current or history of excessive alcohol consumption within 6 months of qualifying biopsy
• Uncontrolled Type II diabetes

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Pfizer: A phase 2 dose finding study to evaluate efficacy and safety of PF-06865571 alone and when co-administered with PF-05221304 in patients with NASH with fibrosis stage 2 or 3.
Inclusion Criteria: (EXTENSIVE, here are a few)
• Total NAS score of > 4 along with fibrosis of F2 or F3
• BMI > 25 kg/m with upper limit of 40 kg/m
Exclusion Criteria: (EXTENSIVE, here are a few)
• Current significant alcohol consumption, cirrhosis, hepatitis B, hepatitis C or HCC

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Novo Nordisk: Phase 3a (NASH) NN9931-4553 - The effect of Semaglutide in subjects with Non-cirrhotic Non-alcoholic Steatohepatitis.
Inclusion Criteria:
• Fibrosis stage 2 or stage 3
• Histological evidence of NASH based on a central pathologist evaluation
• A histological NAS ≥ 4 with a score of 1 or more in both steatosis, lobular inflammation and hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy
Exclusion Criteria:
• Known or suspected excessive consumption of alcohol
• Treatment with vitamin E (at doses ≥800 IU/day)
• eGFR < 30 mL/min
• HbA1c > 80 mmol/mol (9.5%)

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Akero: Phase 2b, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Efruxifermin in Non-cirrhotic Subjects with Non-alcoholic Steatohepatitis.
Inclusion Criteria:
• Fibrosis stage 2 or 3
• HX of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, HTN, elevated fasting glucose) or T2DM
Exclusion Criteria:
• Uncontrolled T2DM
• Poorly controlled HTN
• Osteoporosis

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Sagimet: Phase 2b, multi-center, double-blind, randomized, placebo-controlled study of the safety and efficacy of TVB-2640 in subjects with Non-alcoholic Steatohepatitis (NASH).
Inclusion Criteria:
• BMI < 45 kg/m2
• Biopsy proven NASH prior to randomization
• > 8% liver fat on PDFF-MRI during screening period
• Female pts of non-child bearing potential
Exclusion Criteria:
• Hx of harmful alcohol intake within 3 months
• Uncontrolled T2DM
• Stage 4 fibrosis

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HANMI: A phase 2 study to evaluate efficacy, safety and tolerability of HM15211 in patients with biopsy confirmed NASH.
Inclusion Criteria: (EXTENSIVE, here are a few)
• Have a diagnosis of noncirrhotic NASH stage F1-F3 and NAS score > 4
Exclusion Criteria: (EXTENSIVE, here are a few)
• Alcoholic liver disease, cirrhosis, viral hepatitis or autoimmune hepatitis

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Inventiva: A phase 3 study evaluating long-term efficacy and safety of Lanifibranor in patients with NASH fibrosis 2 or 3.
Inclusion Criteria: (EXTENSIVE, here are a few)
• Diagnosis of NASH with Steatosis ≥1
• Activity score A3 or A4
• Fibrosis F2 or F3
• Stable dose Statins for 3 months
Exclusion Criteria: (EXTENSIVE, here are a few)
• Drug-induced liver disease
• Alcoholic liver disease
• Liver cirrhosis or HCC

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BIO89-100: Phase 2b, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of BIO89-100 in subjects with biopsy-confirmed Non-alcoholic Steatohepatitis (NASH).
Inclusion Criteria: (EXTENSIVE, here are a few)
• BMI < 45 kg/m2
• Fibrosis stage 2 or 3
• HX of 2 out of the following (obesity, T2DM, increased triglycerides, decreased HDL, HTN)
Exclusion Criteria: (EXTENSIVE, here are a few)
• Newly diagnosed T2DM
• Uncontrolled HTN
• Contraindication to MRI

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Gilead: A phase 2 study evaluating the safety and efficacy of Semaglutide, and the fixed-dose combination of Cilofexor and Firsocostat, alone and in combination, in subjects with Compensated Cirrhosis (F4) due to NASH.
Inclusion Criteria:
• Adults 18-80 years of age
• Cirrhosis
• Platelet count ≥125,000
Exclusion Criteria:
• Decompensated liver disease
• Child Pugh score >6

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Galectin: A phase 2b/3 study to evaluate the efficacy and safety of Belapectin for the prevention of Esophageal Varices.
Inclusion Criteria: (EXTENSIVE, here are a few)
• Confirmed diagnosis of NASH cirrhosis. Historical biopsy if available, if not biopsy will be done during screening
Exclusion Criteria: (EXTENSIVE, here are a few)
• Presence of esophageal, gastroesophageal or isolated gastric varices or history of hepatic cirrhosis decompensation including variceal bleeding

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Akero (SYMMETRY): A phase 2b study evaluating the safety and efficacy of Efruxifermin in subjects with Compensated Cirrhosis due to Non-alcoholic Steatohepatitis (NASH).
Inclusion Criteria: (EXTENSIVE, here are a few)
• Fibrosis stage 4
• T2 DM
• 18-75 years of age
Exclusion Criteria: (EXTENSIVE, here are a few)
• Uncontrolled HTN or T2DM
• Child Pugh score >6

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Novo Nordisk 4656: Efficacy and safety investigation of NNC0194-0499 co-administered with Semaglutide in subjects with Non-alcoholic Steatohepatitis: a dose-ranging, placebo-controlled trial.
Inclusion Criteria: (EXTENSIVE, here are a few)
• Histological evidence of fibrosis stage 2, 3, or 4 according to the liver biopsy
• 18 years of age or >
Exclusion Criteria: (EXTENSIVE, here are a few)
• Presence or history of ascites more than grade 1, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or liver transplantation at V2A
• Known or suspected excessive consumption of alcohol

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Salix: A study to assess the efficacy and safety of Rifaximin soluble solid dispersion (SSD) tablets for the delay of Encephalopathy decompensation in cirrhosis (red-c).
Inclusion Criteria: (EXTENSIVE, here are a few)
• Liver cirrhosis with medically controlled ascites (>30 days) not requiring paracentesis
• 18-70 years of age
Exclusion Criteria: (EXTENSIVE, here are a few)
• History of anaphylaxis or hypersensitivity to Rifaximin, Rifampin, Rifamycin antimicrobial agents, or any of the components of Rifaximin
• History of drug-induced liver injury
• Drug rash with eosinophilia and systemic symptom (DRESS) syndrome

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Genkyotex Suisse SA: A 52-week phase 2b/3 trial of Setanaxib with a 52-week extension phase in patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness.
Inclusion Criteria: (EXTENSIVE, here are a few)
• Liver biopsy consistent with PBC
• Serum ALP ≥1.67xULN at screening
Exclusion Criteria: (EXTENSIVE, here are a few)
• History of liver transplantation, current placement on a liver transplant list, or current MELD score of ≥12 unless the patient is on anticoagulant therapy, or a Child Pugh score of ≥6
• Cirrhosis with complications

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Nuerogastrix: A phase 2 study of the safety and efficacy of NG101 administered orally to patients with Gastroparesis.
Inclusion Criteria: (EXTENSIVE, here are a few)
• Diagnosis of diabetic or idiopathic gastroparesis
• ≥ 18 years of age
Exclusion Criteria: (EXTENSIVE, here are a few)
• Participant has another active disorder that can cause abdominal pain or discomfort, nausea, vomiting, fullness, bloating, or other gastrointestinal symptoms that may confound the assessment of gastroparesis symptoms
• Participant has been hospitalized for uncontrolled diabetes mellitus, gastroparesis, or associated malnutrition within 2 months of screening

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Innovate: A phase 3 study to evaluate the efficacy and safety of Larazotide for relief of persistent symptoms in patients with Celiac Disease on a gluten-free diet. Larazotide acetate (INN-202) is a novel oral peptide that has consistently demonstrated the reduction of symptoms of celiac disease in multiple clinical trials. INN-202 helps restore “leaky” or open junctions to a normal state. INN-202, when ingested prior to a meal, may help keep the tight junctions closed, thus reducing the intestinal-inflammatory process in response to gluten.
Inclusion Criteria: (EXTENSIVE, here are a few)
• Male and female adults diagnosed with celiac disease
• On a gluten-free diet for at least 6 months & willing to maintain gluten-free diet throughout study
• Experiencing symptoms (i.e. abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea)
Exclusion Criteria: (EXTENSIVE, here are a few)
• Refractory celiac disease or severe complications of celiac disease
• Chronic GI disease other than celiac disease

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Studies Closed to Enrollment

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Regeneron: A phase 3 study to evaluate the efficacy and safety of Dupilumab in adults and adolescents with Eosinophilic Esophagitis.

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Allergan: A phase 2 clinical trial to assess the efficacy and safety of Brazikumab in patients with moderately to severely active Ulcerative Colitis.

Allergan: A phase 2 clinical trial to assess the efficacy and safety of Brazikumab in patients with moderately to severely active Crohn’s Disease.

Allergan: A phase 3 clinical trial to assess the safety and efficacy of Cenicriviroc (CVC) for the treatment of NASH in adult patients. The primary objective of this study is to demonstrate superiority of CVC compared to placebo on liver histology at month 12 biopsy vs baseline, in patients with fibrosis, by at least 1 stage AND no worsening of steatohepatitis.

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Rebiotix: A phase 3 clinical study to evaluate the efficacy and safety of Rebiotix RBX2660 (microbiota suspension) for the prevention of recurrent Clostridium Difficile Infection (CD3-2).

a. Rebiotix: Open label study to evaluate the efficacy and safety of Rebiotix REX2660.

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IRONWOOD: A phase 3 study to evaluate the efficacy of a new oral medication for Gastroesophageal Reflux Disease (GERD) in patients who are also receiving PPI.

Intercept: A phase 3 study to evaluate the efficacy and safety of Obeticholic Acid in subjects with Compensated Cirrhosis due to NASH.

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Allergan: A phase 3 study to evaluate the safety and efficacy of Relamorelin in patients with Diabetic Gastroparesis. There are three separate arms of this study, short term, long term and one arm for patients that have fewer episodes of vomiting. There is a significant unmet medical need for a safe and effective treatment of patients with Diabetic Gastroparesis whose quality of life is impacted by their disease and for whom the current standard of care is sub-optimal.