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NCT05415722 Clinical Trial

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

NASH - Nonalcoholic Steatohepatitis Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a 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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05415722
Other study ID # TERNCB-2002
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 7, 2022
Est. completion date July 10, 2023

Study information
Verified date September 2023
Source Terns, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 162
Est. completion date July 10, 2023
Est. primary completion date July 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Key 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 diagnosed by prior biopsy and/or imaging criteria - Written informed consent Key Exclusion Criteria: - 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

Related Conditions & MeSH terms

  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• TERN-501
Investigational drug
• TERN-101
Investigational drug
Other:
• Placebo
Matching placebo

Locations
Country Name City State
United States Site 1005:Texas Clinical Research Institute, LLC Arlington Texas
United States Site 1050: Pinnacle Clinical Research Austin Texas
United States Site 1062 Excel Medical Clinical Trials, LLC Boca Raton Florida
United States Site 1017: The Institute for Liver Health dba Arizona Liver Health Chandler Arizona
United States Site 1059: Premier Medical Group Clarksville Tennessee
United States Site 1004 Southern California Research Center Coronado California
United States Site 1057:Integrity Clinical Research, LLC Doral Florida
United States Site 1051: South Texas Research Institute Edinburg Texas
United States Site 1063 GI Alliance - Flowood Flowood Mississippi
United States Site 1061 Velocity Clinical Research, Gardena Gardena California
United States Site 1039: Houston Research Institute Houston Texas
United States Site 1043 Liver Specialists of Texas Houston Texas
United States Site 1046 Houston Methodist Hospital Houston Texas
United States Site 1032 IU Health University Hospital Indianapolis Indiana
United States Site 1013 University of California, San Diego - Altman Clinical and Translational Research Institute La Jolla California
United States Site 1041: Florida Research Institute Lakewood Ranch Florida
United States Site 1016 Ruane Clinical Research Group Inc. Los Angeles California
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 1058 Optimus U Corporation Miami Florida
United States Site 1007: Floridian Clinical Research, LLC Miami Lakes Florida
United States Site 1060 Catalina Research Institute, LLC Montclair California
United States Site 1042: Lucas Research, Inc Morehead City North Carolina
United States Site 1044: Quality Medical Research Nashville Tennessee
United States Site 1001 National Research Institute Panorama City California
United States Site 1055: Progressive Medical Research Port Orange Florida
United States Site 1040 Inland Empire Clinical Trials, LLC Rialto California
United States Site 1053 Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond Richmond Virginia
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 1022 Liver Institute Northwest Seattle Washington
United States Site 1054 Louisiana Research Center Shreveport Louisiana
United States Site 1018: Arizona Liver Health Tucson Arizona
United States Site 1052: Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa

Sponsors (1)
Lead Sponsor Collaborator
Terns, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Relative change from baseline in MRI-PDFF at Week 12 for TERN-501 monotherapy (Arms 1, 2 and 3) compared to placebo 12 weeks
Secondary Change from baseline in cT1 relaxation time at Week 12 for TERN-501 monotherapy (Arms 1, 2 and 3) compared to placebo 12 weeks
Secondary 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
Secondary 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
Secondary Patient incidence of treatment emergent adverse events for all treatment groups 16 weeks
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