Clinical trial NCT05415722: 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: Nonalcoholic steatohepatitis (NASH)
FXR agonist
Nonalcoholic Fatty Liver Disease (NAFLD)
THR-β agonist
Lead sponsor: Terns, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-13
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo
timeFrame: 12 weeks
measure: Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo
timeFrame: 12 weeks
measure: Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo
timeFrame: 12 weeks
measure: Number and Percentage of Participants With Any Treatment Emergent Adverse Event for All Treatment Groups (Threshold of 0%)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Site 1017: The Institute for Liver Health dba Arizona Liver Health
state: Arizona
city: Tucson
country: United States
facility: Site 1018: Arizona Liver Health
state: Arizona
city: Coronado
country: United States
facility: Site 1004 Southern California Research Center
state: California
city: Gardena
country: United States
facility: Site 1061 Velocity Clinical Research, Gardena
state: California
city: La Jolla
country: United States
facility: Site 1013 University of California, San Diego - Altman Clinical and Translational Research Institute
state: California
city: Los Angeles
country: United States
facility: Site 1016 Ruane Clinical Research Group Inc.
state: California
city: Montclair
country: United States
facility: Site 1060 Catalina Research Institute, LLC
state: California
city: Panorama City
country: United States
facility: Site 1001 National Research Institute
state: California
city: Rialto
country: United States
facility: Site 1040 Inland Empire Clinical Trials, LLC
state: California
city: Boca Raton
country: United States
facility: Site 1062 Excel Medical Clinical Trials, LLC
state: Florida
city: Doral
country: United States
facility: Site 1057:Integrity Clinical Research, LLC
state: Florida
city: Lakewood Ranch
country: United States
facility: Site 1041: Florida Research Institute
state: Florida
city: Miami Lakes
country: United States
facility: Site 1007: Floridian Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Site 1058 Optimus U Corporation
state: Florida
city: Miami
country: United States
facility: Site 1036 Schiff Center for Liver Diseases / University of Miami
state: Florida
city: Miami
country: United States
facility: Site 1045 University of Miami Hospital & Clinics, Sylvester Comp. Cancer Center
state: Florida
city: Port Orange
country: United States
facility: Site 1055: Progressive Medical Research
state: Florida
city: Indianapolis
country: United States
facility: Site 1032 IU Health University Hospital
state: Indiana
city: West Des Moines
country: United States
facility: Site 1052: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Shreveport
country: United States
facility: Site 1054 Louisiana Research Center
state: Louisiana
city: Flowood
country: United States
facility: Site 1063 GI Alliance - Flowood
state: Mississippi
city: Morehead City
country: United States
facility: Site 1042: Lucas Research, Inc
state: North Carolina
city: Clarksville
country: United States
facility: Site 1059: Premier Medical Group
state: Tennessee
city: Nashville
country: United States
facility: Site 1044: Quality Medical Research
state: Tennessee
city: Arlington
country: United States
facility: Site 1005:Texas Clinical Research Institute, LLC
state: Texas
city: Austin
country: United States
facility: Site 1050: Pinnacle Clinical Research
state: Texas
city: Edinburg
country: United States
facility: Site 1051: South Texas Research Institute
state: Texas
city: Houston
country: United States
facility: Site 1043 Liver Specialists of Texas
state: Texas
city: Houston
country: United States
facility: Site 1046 Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Site 1039: Houston Research Institute
state: Texas
city: San Antonio
country: United States
facility: Site 1003: Clinical Trials of Texas, LLC
state: Texas
city: San Antonio
country: United States
facility: Site 1006: American Research Corporation
state: Texas
city: San Antonio
country: United States
facility: Site 1056: Pinnacle Clinical Research
state: Texas
city: Richmond
country: United States
facility: Site 1053 Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond
state: Virginia
city: Seattle
country: United States
facility: Site 1022 Liver Institute Northwest
state: Washington
Study officials:
affiliation: Terns, Inc.
name: Study Director
role: STUDY_DIRECTOR
References: