A Multi-Center, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Proof of Concept, Adaptive, Phase 1b Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Orally Administered TERN-201 in Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Terns, Inc.
- Enrollment
- 52
- Locations
- 11
- Primary Endpoint
- Treatment-Emergent Laboratory Abnormalities
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Triple
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 based on clinical characteristics or prior liver biopsy
- •ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women
- •MRI-cT1 value> 800 ms
- •Written informed consent
Exclusion Criteria
- •History or clinical evidence of chronic liver diseases other than NAFLD
- •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
- •Weight loss of > 5% total body weight within 3 months prior to Screening
- •Note: Other protocol-defined inclusion/exclusion criteria could apply.
Arms & Interventions
TERN-201 10mg
Orally administered
Intervention: TERN-201 (Drug)
TERN-201 20mg
Orally Administered
Intervention: TERN-201 (Drug)
Placebo
Orally administered
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Treatment-Emergent Laboratory Abnormalities
Time Frame: Day 1 through Week 16
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
Patient Incidence of Adverse Events for TERN-201 Versus Placebo
Time Frame: Day 1 through Week 16
Number of patients experiencing at least 1 TEAE (Safety Analysis Set). TEAE = Treatment-emergent adverse event. Please see additional details in Adverse Events section.
Secondary Outcomes
No secondary outcomes reported