DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis

Launched by TERNS, INC. · Jun 8, 2022

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Male or female, 18 to 75 years of age
• • Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
• • Presumed NASH diagnosed by prior biopsy and/or imaging criteria
• • Written informed consent
• Key Exclusion Criteria:
• • History or clinical evidence of chronic liver diseases other than NAFLD
• • History or known clinical evidence of cirrhosis, esophageal varices, hepatic decompensation or other severe liver impairment,
• • History of liver transplant, or current placement on a liver transplant list
• • Current diagnosis or history of pituitary or thyroid disorders - except for patients with primary hypothyroidism on a stable dose of thyroid hormone replacement therapy.
• • Abnormal TSH or free T4 levels
• • Weight loss of \> 5% total body weight within 3 months prior to Screening
• • Uncontrolled diabetes
• • Uncontrolled hyperlipidemia
• • Unstable cardiovascular disease
• • Excessive alcohol consumption
• • Other protocol-defined I/E criteria that apply.