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
NCT ID: NCT05415722
Last Updated: 2025-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
162 participants
INTERVENTIONAL
2022-06-28
2023-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1: TERN-501 1 mg
Orally administered.
TERN-501
Investigational drug
Arm 2: TERN-501 3 mg
Orally administered.
TERN-501
Investigational drug
Arm 3: TERN-501 6 mg
Orally administered.
TERN-501
Investigational drug
Arm 4: TERN-501 3 mg + TERN-101 10 mg
Orally administered.
TERN-501
Investigational drug
TERN-101
Investigational drug
Arm 5: TERN-501 6 mg + TERN-101 10 mg
Orally administered.
TERN-501
Investigational drug
TERN-101
Investigational drug
Arm 6:TERN-101 10 mg
Orally administered.
TERN-101
Investigational drug
Arm 7: Matching placebo
Orally administered.
Placebo
Matching placebo
Interventions
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TERN-501
Investigational drug
TERN-101
Investigational drug
Placebo
Matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Terns, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Terns, Inc.
Locations
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Site 1017: The Institute for Liver Health dba Arizona Liver Health
Chandler, Arizona, United States
Site 1018: Arizona Liver Health
Tucson, Arizona, United States
Site 1004 Southern California Research Center
Coronado, California, United States
Site 1061 Velocity Clinical Research, Gardena
Gardena, California, United States
Site 1013 University of California, San Diego - Altman Clinical and Translational Research Institute
La Jolla, California, United States
Site 1016 Ruane Clinical Research Group Inc.
Los Angeles, 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 1062 Excel Medical Clinical Trials, LLC
Boca Raton, Florida, United States
Site 1057:Integrity Clinical Research, LLC
Doral, Florida, United States
Site 1041: Florida Research Institute
Lakewood Rch, 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 1007: Floridian Clinical Research, LLC
Miami Lakes, Florida, United States
Site 1055: Progressive Medical Research
Port Orange, Florida, United States
Site 1032 IU Health University Hospital
Indianapolis, Indiana, 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 1063 GI Alliance - Flowood
Flowood, Mississippi, United States
Site 1042: Lucas Research, Inc
Morehead City, North Carolina, United States
Site 1059: Premier Medical Group
Clarksville, Tennessee, United States
Site 1044: Quality Medical Research
Nashville, Tennessee, United States
Site 1005:Texas Clinical Research Institute, LLC
Arlington, Texas, United States
Site 1050: Pinnacle Clinical Research
Austin, Texas, United States
Site 1051: South Texas Research Institute
Edinburg, Texas, United States
Site 1043 Liver Specialists of Texas
Houston, Texas, United States
Site 1046 Houston Methodist Hospital
Houston, Texas, United States
Site 1039: Houston Research Institute
Houston, Texas, United States
Site 1003: Clinical Trials of Texas, LLC
San Antonio, Texas, United States
Site 1006: American Research Corporation
San Antonio, Texas, United States
Site 1056: Pinnacle Clinical Research
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 1022 Liver Institute Northwest
Seattle, Washington, United States
Countries
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References
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Noureddin M, Alkhouri N, Lawitz EJ, Kowdley KV, Loomba R, Lee L, Jones C, Schlegel A, Marmon T, Anderson K, Li Y, Quirk E, Harrison SA. TERN-501 monotherapy and combination therapy with TERN-101 in metabolic dysfunction-associated steatohepatitis: the randomized phase 2a DUET trial. Nat Med. 2025 Jul;31(7):2297-2305. doi: 10.1038/s41591-025-03722-7. Epub 2025 Jun 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TERNCB-2002
Identifier Type: -
Identifier Source: org_study_id
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