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LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
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 Farnesoid X receptor, NASH, Nonalcoholic Steatohepatitis, NAFLD, Nonalcoholic Fatty Liver Disease, FXR

Eligibility Criteria

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

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 based on clinical characteristics or prior liver biopsy
  • ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women
  • MRI PDFF liver fat content ≥ 10 %
  • Written informed consent

Exclusion Criteria:

  • History or clinical evidence of chronic liver diseases other than NAFLD
  • History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment
  • History of liver transplant, or current placement on a liver transplant list
  • Total bilirubin > 1.2 mg/dL
  • Albumin < 3.5 g/dL
  • INR > 1.1
  • AST or ALT > 5 x ULN
  • ALP > 156 IU/L
  • Platelet count < 150,000 /mm3
  • eGFR < 60 mL/min/1.73m2
  • Weight loss > 5% within past 3 months prior to Screening
  • Uncontrolled diabetes
  • Uncontrolled hyperlipidemia
  • Active COVID-19 infection
  • Other protocol-defined inclusion/exclusion criteria could apply

Sites / Locations

  • Terns Clinical Study Site 1017
  • Terns Clinical Study Site 1018
  • Terns Clinical Study Site 1024
  • Terns Clinical Study Site 1004
  • Terns Clinical Study Site 1035
  • Terns Clinical Study Site 1013
  • Terns Clinical Study Site 1016
  • Terns Clinical Study Site 1008
  • Terns Clinical Study Site 1001
  • Terns Clinical Study Site 1012
  • Terns Clinical Study Site 1007
  • Terns Clinical Study Site 1028
  • Terns Clinical Study Site 1009
  • Terns Clinical Study Site 1033
  • Terns Clinical Study Site 1032
  • Terns Clinical Study Site 1010
  • Terns Clinical Study Site 1037
  • Terns Clinical Study Site 1023
  • Terns Clinical Study Site 1002
  • Terns Clinical Study Site 1011
  • Terns Clinical Study Site 1038
  • Terns Clinical Study Site 1027
  • Terns Clinical Study Site 1014
  • Terns Clinical Study Site 1005
  • Terns Clinical Study Site 1025
  • Terns Clinical Study Site 1021
  • Terns Clinical Study Site 1029
  • Terns Clinical Study Site 1006
  • Terns Clinical Study Site 1003
  • Terns Clinical Study Site 1019
  • Terns Clinical Study Site 1022

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

TERN-101 dose level 1

TERN-101 dose level 2

TERN-101 dose level 3

Placebo

Arm Description

Orally administered.

Orally administered.

Orally administered.

Orally administered.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events for TERN-101 Versus Placebo

Secondary Outcome Measures

Percent Change From Baseline in ALT Outcome Measure
Plasma Concentration of TERN-101 - AUC 0-24
Area under the curve
Plasma Concentration of TERN-101 - Cmax
Maximum observed concentration
Plasma Concentration of TERN-101 - Tmax
Time to reach maximum measured plasma concentration
Plasma Concentration of TERN-101 - t1/2
Determination of half-life

Full Information

First Posted
March 13, 2020
Last Updated
July 12, 2022
Sponsor
Terns, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04328077
Brief Title
LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered TERN-101 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 18, 2020 (Actual)
Primary Completion Date
May 19, 2021 (Actual)
Study Completion Date
May 19, 2021 (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 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic NASH patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis
Keywords
Farnesoid X receptor, NASH, Nonalcoholic Steatohepatitis, NAFLD, Nonalcoholic Fatty Liver Disease, FXR

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
TERN-101 dose level 1
Arm Type
Experimental
Arm Description
Orally administered.
Arm Title
TERN-101 dose level 2
Arm Type
Experimental
Arm Description
Orally administered.
Arm Title
TERN-101 dose level 3
Arm Type
Experimental
Arm Description
Orally administered.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Orally administered.
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
Number of Participants With Adverse Events for TERN-101 Versus Placebo
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in ALT Outcome Measure
Time Frame
12 weeks
Title
Plasma Concentration of TERN-101 - AUC 0-24
Description
Area under the curve
Time Frame
12 weeks (0-24 hours post dose)
Title
Plasma Concentration of TERN-101 - Cmax
Description
Maximum observed concentration
Time Frame
12 Weeks (0-72 hours post dose)
Title
Plasma Concentration of TERN-101 - Tmax
Description
Time to reach maximum measured plasma concentration
Time Frame
12 Weeks (0-72 hours post dose)
Title
Plasma Concentration of TERN-101 - t1/2
Description
Determination of half-life
Time Frame
12 Weeks (0-72 hours post dose)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 based on clinical characteristics or prior liver biopsy ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women MRI PDFF liver fat content ≥ 10 % Written informed consent Exclusion Criteria: History or clinical evidence of chronic liver diseases other than NAFLD History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment History of liver transplant, or current placement on a liver transplant list Total bilirubin > 1.2 mg/dL Albumin < 3.5 g/dL INR > 1.1 AST or ALT > 5 x ULN ALP > 156 IU/L Platelet count < 150,000 /mm3 eGFR < 60 mL/min/1.73m2 Weight loss > 5% within past 3 months prior to Screening Uncontrolled diabetes Uncontrolled hyperlipidemia Active COVID-19 infection Other protocol-defined inclusion/exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
clinicaltrials@ternspharma.com
Organizational Affiliation
Terns, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Terns Clinical Study Site 1017
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Terns Clinical Study Site 1018
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Terns Clinical Study Site 1024
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Terns Clinical Study Site 1004
City
Coronado
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Terns Clinical Study Site 1035
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Terns Clinical Study Site 1013
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Terns Clinical Study Site 1016
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Terns Clinical Study Site 1008
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Terns Clinical Study Site 1001
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Terns Clinical Study Site 1012
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Terns Clinical Study Site 1007
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Terns Clinical Study Site 1028
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Terns Clinical Study Site 1009
City
Miami
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Terns Clinical Study Site 1033
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Terns Clinical Study Site 1032
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Terns Clinical Study Site 1010
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71220
Country
United States
Facility Name
Terns Clinical Study Site 1037
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Terns Clinical Study Site 1023
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Terns Clinical Study Site 1002
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Terns Clinical Study Site 1011
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Terns Clinical Study Site 1038
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
Terns Clinical Study Site 1027
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Terns Clinical Study Site 1014
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Terns Clinical Study Site 1005
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Terns Clinical Study Site 1025
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78628
Country
United States
Facility Name
Terns Clinical Study Site 1021
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Terns Clinical Study Site 1029
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Terns Clinical Study Site 1006
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Terns Clinical Study Site 1003
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Terns Clinical Study Site 1019
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Terns Clinical Study Site 1022
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

LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)

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