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Biotech / Medical : Madrigal Pharmaceuticals
MDGL 412.28-1.6%Nov 3 3:59 PM EST
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To: Miljenko Zuanic who wrote (85)4/4/2019 11:21:31 AM
From: Miljenko Zuanic  Read Replies (2) of 138
 
Why they are excluding diabetic population:
<Exclusion Criteria:
History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.Regular use of drugs historically associated with NAFLDHistory of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study.Recent significant weight gain or lossHbA1c = 9.0%.Glucagon-like peptide 1 [GLP-1] agonist , high dose Vitamin E (> 400 IU/day) or pioglitazone therapy unless stable dose for 24 weeks prior to biopsy.Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.Diagnosis of hepatocellular carcinoma (HCC).MELD score =12, as determined at Screening, unless due to therapeutic anti coagulation.Hepatic decompensationChronic liver diseases other than NASHActive autoimmune diseaseSerum ALT > 250 U/L.Active, serious medical disease with a likely life expectancy < 2 years.Participation in an investigational new drug trial in the 60 days or 5 half-lives, whichever is longer.Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.
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