This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
52
Terns Clinical Study Site 1018
Tucson, Arizona, United States
Terns Clinical Study Site 1024
Tucson, Arizona, United States
Terns Clinical Study Site 1004
Coronado, California, United States
Patient Incidence of Adverse Events for TERN-201 Versus Placebo
Number of patients experiencing at least 1 TEAE (Safety Analysis Set). TEAE = Treatment-emergent adverse event. Please see additional details in Adverse Events section.
Time frame: Day 1 through Week 16
Treatment-Emergent Laboratory Abnormalities
Number of patients with any worsening of ≥ 2 NCI CTCAE Grades in each laboratory assessment category. CTCAE = Common Terminology Criteria for Adverse Events; NCI = National Cancer Institute; laboratory abnormalities were classified according to NCI CTCAE, version 5, Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-Threatening
Time frame: Day 1 through Week 16
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Terns Clinical Study Site 1039
Los Angeles, California, United States
Terns Clinical Study Site 1001
Panorama City, California, United States
Terns Clinical Study Site 1040
Rialto, California, United States
Terns Clinical Study Site 1013
San Diego, California, United States
Terns Clinical Study Site 1010
Bastrop, Louisiana, United States
Terns Clinical Study Site 1006
San Antonio, Texas, United States
Terns Clinical Study Site 1003
San Antonio, Texas, United States
...and 1 more locations