TERN-201 in Presumed Non-Cirrhotic NASH
Condition: Nonalcoholic steatohepatitis
Key Inclusion Criteria:
- 18-75 years old
- Nonalcoholic steatohepatitis (NASH) by clinical diagnosis or biopsy
- Overweight or obese with a BMI ≥25 kg/m2
Key Exclusion Criteria:
- History or clinical evidence of chronic liver diseases other than nonalcoholic fatty liver disease (NAFLD) or NASH
- History or clinical evidence of cirrhosis, hepatic decompensation, or other severe liver impairment
- History of liver transplant or current placement on a liver transplant list
A Multicenter, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Proof of Concept, Adaptive, Phase Ib Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Orally Administered TERN-201 in Patients With Presumed Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH) (IRB no. 00001541)
This study focuses on individuals who have characteristics associated with nonalcoholic steatohepatitis (NASH). The purpose of the study is to evaluate the safety and tolerability of a drug called TERN-201, given orally (by mouth) in patients who are thought to have NASH, a form of nonalcoholic fatty liver disease (NAFLD). TERN-201 is an investigational drug being developed for the treatment of NASH, a condition in which there is too much fat in the liver (steatosis), causing inflammation and damage to liver cells in in people who drink little or no alcohol.
Researchers aim to determine how TERN-201 behaves inside the body, as well as how it is removed from the body. Examining samples (blood and urine) collected during the study will provide information on pharmacokinetics and pharmacodynamics that show how the body takes TERN-201 into the blood, delivers and processes the drug, and how it is affected by the drug.
In the first part of the study, participants will be randomly assigned to receive TERN-201 at 10 mg or placebo (inactive substance). In the second part, they will be randomly assigned to receive TERN-201 at 4 mg or placebo. All participants will have a 1 in 3 chance of receiving placebo during the study.