DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Interventions
- Registration Number
- NCT05415722
- Lead Sponsor
- Terns, Inc.
- Brief Summary
This is a Phase 2a Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with Presumed Non-Alcoholic Steatohepatitis (NASH)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
- Male or female, 18 to 75 years of age
- Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
- Presumed NASH diagnosed by prior biopsy and/or imaging criteria
- Written informed consent
Key
- History or clinical evidence of chronic liver diseases other than NAFLD
- History or known clinical evidence of cirrhosis, esophageal varices, hepatic decompensation or other severe liver impairment,
- History of liver transplant, or current placement on a liver transplant list
- Current diagnosis or history of pituitary or thyroid disorders - except for patients with primary hypothyroidism on a stable dose of thyroid hormone replacement therapy.
- Abnormal TSH or free T4 levels
- Weight loss of > 5% total body weight within 3 months prior to Screening
- Uncontrolled diabetes
- Uncontrolled hyperlipidemia
- Unstable cardiovascular disease
- Excessive alcohol consumption
Other protocol-defined I/E criteria that apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 4: TERN-501 3 mg + TERN-101 10 mg TERN-501 Orally administered. Arm 2: TERN-501 3 mg TERN-501 Orally administered. Arm 5: TERN-501 6 mg + TERN-101 10 mg TERN-501 Orally administered. Arm 3: TERN-501 6 mg TERN-501 Orally administered. Arm 5: TERN-501 6 mg + TERN-101 10 mg TERN-101 Orally administered. Arm 7: Matching placebo Placebo Orally administered. Arm 6:TERN-101 10 mg TERN-101 Orally administered. Arm 1: TERN-501 1 mg TERN-501 Orally administered. Arm 4: TERN-501 3 mg + TERN-101 10 mg TERN-101 Orally administered.
- Primary Outcome Measures
Name Time Method Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo. 12 weeks Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a non-invasive imaging technique that measures fat content in tissue, particularly in the liver. Relative change from baseline is calculated for each subject as 100 x \[(Week 12 Value - Baseline Value)/Baseline Value\].
- Secondary Outcome Measures
Name Time Method Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo 12 weeks Corrected T1 (cT1) is a quantitative MRI relaxation parameter that measures liver inflammation and fibrosis. Change from baseline is calculated for each subject as (Week 12 Value - Baseline Value).
Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo 12 weeks Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a non-invasive imaging technique that measures fat content in tissue, particularly in the liver. Relative change from baseline is calculated for each subject as 100 x \[(Week 12 Value - Baseline Value)/Baseline Value\].
Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo 12 weeks Corrected T1 (cT1) is a quantitative MRI relaxation parameter that measures liver inflammation and fibrosis. Change from baseline is calculated for each subject as (Week 12 Value - Baseline Value).
Number and Percentage of Participants With Any Treatment Emergent Adverse Event for All Treatment Groups (Threshold of 0%) 16 weeks This outcome measures the number and percentage of participants with any Treatment Emergent Adverse Event (TEAE) for All Treatment Groups (0% Threshold). TEAEs by System Organ Class and Preferred Term meeting the 5% Threshold are reported in the Other Adverse Events section.
Trial Locations
- Locations (35)
Site 1003: Clinical Trials of Texas, LLC
🇺🇸San Antonio, Texas, United States
Site 1006: American Research Corporation
🇺🇸San Antonio, Texas, United States
Site 1053 Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond
🇺🇸Richmond, Virginia, United States
Site 1056: Pinnacle Clinical Research
🇺🇸San Antonio, Texas, United States
Site 1062 Excel Medical Clinical Trials, LLC
🇺🇸Boca Raton, Florida, United States
Site 1057:Integrity Clinical Research, LLC
🇺🇸Doral, Florida, United States
Site 1043 Liver Specialists of Texas
🇺🇸Houston, Texas, United States
Site 1022 Liver Institute Northwest
🇺🇸Seattle, Washington, United States
Site 1005:Texas Clinical Research Institute, LLC
🇺🇸Arlington, Texas, United States
Site 1039: Houston Research Institute
🇺🇸Houston, Texas, United States
Site 1046 Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Site 1018: Arizona Liver Health
🇺🇸Tucson, Arizona, United States
Site 1016 Ruane Clinical Research Group Inc.
🇺🇸Los Angeles, California, United States
Site 1061 Velocity Clinical Research, Gardena
🇺🇸Gardena, California, United States
Site 1060 Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Site 1001 National Research Institute
🇺🇸Panorama City, California, United States
Site 1040 Inland Empire Clinical Trials, LLC
🇺🇸Rialto, California, United States
Site 1041: Florida Research Institute
🇺🇸Lakewood Ranch, Florida, United States
Site 1007: Floridian Clinical Research, LLC
🇺🇸Miami Lakes, Florida, United States
Site 1058 Optimus U Corporation
🇺🇸Miami, Florida, United States
Site 1036 Schiff Center for Liver Diseases / University of Miami
🇺🇸Miami, Florida, United States
Site 1045 University of Miami Hospital & Clinics, Sylvester Comp. Cancer Center
🇺🇸Miami, Florida, United States
Site 1055: Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Site 1052: Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
Site 1054 Louisiana Research Center
🇺🇸Shreveport, Louisiana, United States
Site 1032 IU Health University Hospital
🇺🇸Indianapolis, Indiana, United States
Site 1042: Lucas Research, Inc
🇺🇸Morehead City, North Carolina, United States
Site 1050: Pinnacle Clinical Research
🇺🇸Austin, Texas, United States
Site 1051: South Texas Research Institute
🇺🇸Edinburg, Texas, United States
Site 1044: Quality Medical Research
🇺🇸Nashville, Tennessee, United States
Site 1063 GI Alliance - Flowood
🇺🇸Flowood, Mississippi, United States
Site 1059: Premier Medical Group
🇺🇸Clarksville, Tennessee, United States
Site 1017: The Institute for Liver Health dba Arizona Liver Health
🇺🇸Chandler, Arizona, United States
Site 1004 Southern California Research Center
🇺🇸Coronado, California, United States
Site 1013 University of California, San Diego - Altman Clinical and Translational Research Institute
🇺🇸La Jolla, California, United States