NASH - Nonalcoholic Steatohepatitis Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered TERN-101 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Verified date | July 2022 |
Source | Terns, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic NASH patients.
Status | Completed |
Enrollment | 101 |
Est. completion date | May 19, 2021 |
Est. primary completion date | May 19, 2021 |
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 PDFF liver fat content = 10 % - 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 - Total bilirubin > 1.2 mg/dL - Albumin < 3.5 g/dL - INR > 1.1 - AST or ALT > 5 x ULN - ALP > 156 IU/L - Platelet count < 150,000 /mm3 - eGFR < 60 mL/min/1.73m2 - Weight loss > 5% within past 3 months prior to Screening - Uncontrolled diabetes - Uncontrolled hyperlipidemia - Active COVID-19 infection - Other protocol-defined inclusion/exclusion criteria could apply |
Country | Name | City | State |
---|---|---|---|
United States | Terns Clinical Study Site 1005 | Arlington | Texas |
United States | Terns Clinical Study Site 1002 | Baltimore | Maryland |
United States | Terns Clinical Study Site 1010 | Bastrop | Louisiana |
United States | Terns Clinical Study Site 1011 | Boston | Massachusetts |
United States | Terns Clinical Study Site 1017 | Chandler | Arizona |
United States | Terns Clinical Study Site 1004 | Coronado | California |
United States | Terns Clinical Study Site 1027 | Durham | North Carolina |
United States | Terns Clinical Study Site 1038 | Florham Park | New Jersey |
United States | Terns Clinical Study Site 1035 | Fresno | California |
United States | Terns Clinical Study Site 1012 | Gainesville | Florida |
United States | Terns Clinical Study Site 1025 | Georgetown | Texas |
United States | Terns Clinical Study Site 1014 | Hermitage | Tennessee |
United States | Terns Clinical Study Site 1007 | Hialeah | Florida |
United States | Terns Clinical Study Site 1028 | Hialeah | Florida |
United States | Terns Clinical Study Site 1021 | Houston | Texas |
United States | Terns Clinical Study Site 1029 | Houston | Texas |
United States | Terns Clinical Study Site 1032 | Indianapolis | Indiana |
United States | Terns Clinical Study Site 1013 | La Jolla | California |
United States | Terns Clinical Study Site 1016 | Los Angeles | California |
United States | Terns Clinical Study Site 1009 | Miami | Florida |
United States | Terns Clinical Study Site 1008 | Montclair | California |
United States | Terns Clinical Study Site 1037 | New Orleans | Louisiana |
United States | Terns Clinical Study Site 1033 | Orlando | Florida |
United States | Terns Clinical Study Site 1001 | Panorama City | 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 1022 | Seattle | Washington |
United States | Terns Clinical Study Site 1023 | Shreveport | Louisiana |
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 | Number of Participants With Adverse Events for TERN-101 Versus Placebo | 16 weeks | ||
Secondary | Percent Change From Baseline in ALT Outcome Measure | 12 weeks | ||
Secondary | Plasma Concentration of TERN-101 - AUC 0-24 | Area under the curve | 12 weeks (0-24 hours post dose) | |
Secondary | Plasma Concentration of TERN-101 - Cmax | Maximum observed concentration | 12 Weeks (0-72 hours post dose) | |
Secondary | Plasma Concentration of TERN-101 - Tmax | Time to reach maximum measured plasma concentration | 12 Weeks (0-72 hours post dose) | |
Secondary | Plasma Concentration of TERN-101 - t1/2 | Determination of half-life | 12 Weeks (0-72 hours post dose) |
Status | Clinical Trial | Phase | |
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