NASH - Nonalcoholic Steatohepatitis Clinical Trial
Official title:
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)
| Verified date | December 2023 |
| Source | Terns, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | September 2, 2022 |
| Est. primary completion date | September 2, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Terns Clinical Study Site 1010 | Bastrop | Louisiana |
| United States | Terns Clinical Study Site 1004 | Coronado | California |
| United States | 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 1003 | San Antonio | Texas |
| United States | Terns Clinical Study Site 1006 | San Antonio | Texas |
| United States | Terns Clinical Study Site 1019 | San Antonio | Texas |
| United States | Terns Clinical Study Site 1013 | San Diego | California |
| United States | Terns Clinical Study Site 1018 | Tucson | Arizona |
| United States | Terns Clinical Study Site 1024 | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Terns, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Day 1 through Week 16 | |
| Primary | 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 |
Day 1 through Week 16 |
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