Terns Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug application (IND) for TERN-501, a selective thyroid hormone receptor beta, or THR-ß, agonist with enhanced metabolic stability and liver distribution, characteristics that are intended to improve safety and efficacy in NASH patients. Terns expects to initiate a Phase 1 clinical trial for TERN-501 in the first half of 2021, with top-line data anticipated in the second half of 2021. The Phase 1 clinical trial is expected to be a multi-part study enrolling approximately 90 healthy participants. The trial is designed to incorporate both single ascending dose and multiple ascending dose cohorts to assess the safety, tolerability and pharmacokinetics of TERN-501, as well as the reduction in serum lipid levels as an early marker of target engagement.