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

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)

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.

Study Overview

• Status: Completed
• Conditions: NASH - Nonalcoholic Steatohepatitis
• Intervention / Treatment: Other: Placebo; Drug: TERN-101

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Terns Clinical Study Site 1017
    • Tucson, Arizona, United States, 85712
      • Terns Clinical Study Site 1018
    • Tucson, Arizona, United States, 85712
      • Terns Clinical Study Site 1024
  • California
    • Coronado, California, United States, 92117
      • Terns Clinical Study Site 1004
    • Fresno, California, United States, 93720
      • Terns Clinical Study Site 1035
    • La Jolla, California, United States, 92037
      • Terns Clinical Study Site 1013
    • Los Angeles, California, United States, 90036
      • Terns Clinical Study Site 1016
    • Montclair, California, United States, 91763
      • Terns Clinical Study Site 1008
    • Panorama City, California, United States, 91402
      • Terns Clinical Study Site 1001
  • Florida
    • Gainesville, Florida, United States, 32610
      • Terns Clinical Study Site 1012
    • Hialeah, Florida, United States, 33013
      • Terns Clinical Study Site 1007
    • Hialeah, Florida, United States, 33014
      • Terns Clinical Study Site 1028
    • Miami, Florida, United States, 33166
      • Terns Clinical Study Site 1009
    • Orlando, Florida, United States, 32806
      • Terns Clinical Study Site 1033
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Terns Clinical Study Site 1032
  • Louisiana
    • Bastrop, Louisiana, United States, 71220
      • Terns Clinical Study Site 1010
    • New Orleans, Louisiana, United States, 70121
      • Terns Clinical Study Site 1037
    • Shreveport, Louisiana, United States, 71105
      • Terns Clinical Study Site 1023
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Terns Clinical Study Site 1002
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Terns Clinical Study Site 1011
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Terns Clinical Study Site 1038
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Terns Clinical Study Site 1027
  • Tennessee
    • Hermitage, Tennessee, United States, 37076
      • Terns Clinical Study Site 1014
  • Texas
    • Arlington, Texas, United States, 76012
      • Terns Clinical Study Site 1005
    • Georgetown, Texas, United States, 78628
      • Terns Clinical Study Site 1025
    • Houston, Texas, United States, 77030
      • Terns Clinical Study Site 1021
    • Houston, Texas, United States, 77030
      • Terns Clinical Study Site 1029
    • San Antonio, Texas, United States, 78215
      • Terns Clinical Study Site 1006
    • San Antonio, Texas, United States, 78229
      • Terns Clinical Study Site 1003
    • San Antonio, Texas, United States, 78229
      • Terns Clinical Study Site 1019
  • Washington
    • Seattle, Washington, United States, 98105
      • Terns Clinical Study Site 1022

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TERN-101 dose level 1; Orally administered.	Drug: TERN-101; Investigational drug
EXPERIMENTAL: TERN-101 dose level 2; Orally administered.	Drug: TERN-101; Investigational drug
EXPERIMENTAL: TERN-101 dose level 3; Orally administered.	Drug: TERN-101; Investigational drug
PLACEBO_COMPARATOR: Placebo; Orally administered.	Other: Placebo; Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events for TERN-101 Versus Placebo	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in ALT Outcome Measure		12 weeks
Plasma Concentration of TERN-101 - AUC 0-24	Area under the curve	12 weeks (0-24 hours post dose)
Plasma Concentration of TERN-101 - Cmax	Maximum observed concentration	12 Weeks (0-72 hours post dose)
Plasma Concentration of TERN-101 - Tmax	Time to reach maximum measured plasma concentration	12 Weeks (0-72 hours post dose)
Plasma Concentration of TERN-101 - t1/2	Determination of half-life	12 Weeks (0-72 hours post dose)

Collaborators and Investigators

• Sponsor: Terns, Inc.
• Investigators: Study Director: clinicaltrials@ternspharma.com, Terns, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 18, 2020
• Primary Completion (ACTUAL): May 19, 2021
• Study Completion (ACTUAL): May 19, 2021

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (ACTUAL): March 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Nonalcoholic Steatohepatitis; NAFLD; NASH; Nonalcoholic Fatty Liver Disease; FXR; Farnesoid X receptor
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: TERN101-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No