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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | 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
