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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

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TERN-501
TERN-101
Placebo
Sponsored by
Terns, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis focused on measuring Nonalcoholic steatohepatitis (NASH), FXR agonist, Nonalcoholic Fatty Liver Disease (NAFLD), THR-β agonist

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 1017: The Institute for Liver Health dba Arizona Liver Health
  • Site 1018: Arizona Liver Health
  • Site 1004 Southern California Research Center
  • Site 1061 Velocity Clinical Research, Gardena
  • Site 1013 University of California, San Diego - Altman Clinical and Translational Research Institute
  • Site 1016 Ruane Clinical Research Group Inc.
  • Site 1060 Catalina Research Institute, LLC
  • Site 1001 National Research Institute
  • Site 1040 Inland Empire Clinical Trials, LLC
  • Site 1062 Excel Medical Clinical Trials, LLC
  • Site 1057:Integrity Clinical Research, LLC
  • Site 1041: Florida Research Institute
  • Site 1007: Floridian Clinical Research, LLC
  • Site 1058 Optimus U Corporation
  • Site 1036 Schiff Center for Liver Diseases / University of Miami
  • Site 1045 University of Miami Hospital & Clinics, Sylvester Comp. Cancer Center
  • Site 1055: Progressive Medical Research
  • Site 1032 IU Health University Hospital
  • Site 1052: Iowa Diabetes and Endocrinology Research Center
  • Site 1054 Louisiana Research Center
  • Site 1063 GI Alliance - Flowood
  • Site 1042: Lucas Research, Inc
  • Site 1059: Premier Medical Group
  • Site 1044: Quality Medical Research
  • Site 1005:Texas Clinical Research Institute, LLC
  • Site 1050: Pinnacle Clinical Research
  • Site 1051: South Texas Research Institute
  • Site 1043 Liver Specialists of Texas
  • Site 1046 Houston Methodist Hospital
  • Site 1039: Houston Research Institute
  • Site 1003: Clinical Trials of Texas, LLC
  • Site 1006: American Research Corporation
  • Site 1056: Pinnacle Clinical Research
  • Site 1053 Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond
  • Site 1022 Liver Institute Northwest

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1: TERN-501 1 mg

Arm 2: TERN-501 3 mg

Arm 3: TERN-501 6 mg

Arm 4: TERN-501 3 mg + TERN-101 10 mg

Arm 5: TERN-501 6 mg + TERN-101 10 mg

Arm 6:TERN-101 10 mg

Arm 7: Matching placebo

Arm Description

Orally administered.

Orally administered.

Orally administered.

Orally administered.

Orally administered.

Orally administered.

Orally administered.

Outcomes

Primary Outcome Measures

Relative change from baseline in MRI-PDFF at Week 12 for TERN-501 monotherapy (Arms 1, 2 and 3) compared to placebo

Secondary Outcome Measures

Change from baseline in cT1 relaxation time at Week 12 for TERN-501 monotherapy (Arms 1, 2 and 3) compared to placebo
Relative change from baseline in MRI-PDFF at Week 12 for TERN-501+TERN-101 combination (Arms 4 and 5) compared to placebo
Change from baseline in cT1 relaxation time at Week 12 for TERN-501+TERN-101 combination (Arms 4 and 5) compared to placebo
Patient incidence of treatment emergent adverse events for all treatment groups

Full Information

First Posted
June 8, 2022
Last Updated
September 26, 2023
Sponsor
Terns, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05415722
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
July 10, 2023 (Actual)
Study Completion Date
July 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Terns, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis
Keywords
Nonalcoholic steatohepatitis (NASH), FXR agonist, Nonalcoholic Fatty Liver Disease (NAFLD), THR-β agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: TERN-501 1 mg
Arm Type
Experimental
Arm Description
Orally administered.
Arm Title
Arm 2: TERN-501 3 mg
Arm Type
Experimental
Arm Description
Orally administered.
Arm Title
Arm 3: TERN-501 6 mg
Arm Type
Experimental
Arm Description
Orally administered.
Arm Title
Arm 4: TERN-501 3 mg + TERN-101 10 mg
Arm Type
Experimental
Arm Description
Orally administered.
Arm Title
Arm 5: TERN-501 6 mg + TERN-101 10 mg
Arm Type
Experimental
Arm Description
Orally administered.
Arm Title
Arm 6:TERN-101 10 mg
Arm Type
Experimental
Arm Description
Orally administered.
Arm Title
Arm 7: Matching placebo
Arm Type
Placebo Comparator
Arm Description
Orally administered.
Intervention Type
Drug
Intervention Name(s)
TERN-501
Intervention Description
Investigational drug
Intervention Type
Drug
Intervention Name(s)
TERN-101
Intervention Description
Investigational drug
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Relative change from baseline in MRI-PDFF at Week 12 for TERN-501 monotherapy (Arms 1, 2 and 3) compared to placebo
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in cT1 relaxation time at Week 12 for TERN-501 monotherapy (Arms 1, 2 and 3) compared to placebo
Time Frame
12 weeks
Title
Relative change from baseline in MRI-PDFF at Week 12 for TERN-501+TERN-101 combination (Arms 4 and 5) compared to placebo
Time Frame
12 weeks
Title
Change from baseline in cT1 relaxation time at Week 12 for TERN-501+TERN-101 combination (Arms 4 and 5) compared to placebo
Time Frame
12 weeks
Title
Patient incidence of treatment emergent adverse events for all treatment groups
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Terns, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site 1017: The Institute for Liver Health dba Arizona Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Site 1018: Arizona Liver Health
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Site 1004 Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Site 1061 Velocity Clinical Research, Gardena
City
Gardena
State/Province
California
ZIP/Postal Code
90247
Country
United States
Facility Name
Site 1013 University of California, San Diego - Altman Clinical and Translational Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Site 1016 Ruane Clinical Research Group Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Site 1060 Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Site 1001 National Research Institute
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Site 1040 Inland Empire Clinical Trials, LLC
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Site 1062 Excel Medical Clinical Trials, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Site 1057:Integrity Clinical Research, LLC
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Site 1041: Florida Research Institute
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
Site 1007: Floridian Clinical Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Site 1058 Optimus U Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Site 1036 Schiff Center for Liver Diseases / University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Site 1045 University of Miami Hospital & Clinics, Sylvester Comp. Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Site 1055: Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Site 1032 IU Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Site 1052: Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Site 1054 Louisiana Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Site 1063 GI Alliance - Flowood
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Site 1042: Lucas Research, Inc
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Site 1059: Premier Medical Group
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37040
Country
United States
Facility Name
Site 1044: Quality Medical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Site 1005:Texas Clinical Research Institute, LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Site 1050: Pinnacle Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Site 1051: South Texas Research Institute
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Site 1043 Liver Specialists of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site 1046 Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site 1039: Houston Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Site 1003: Clinical Trials of Texas, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Site 1006: American Research Corporation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Site 1056: Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site 1053 Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23236
Country
United States
Facility Name
Site 1022 Liver Institute Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this 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

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