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

July 12, 2022 updated by: Terns, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants With Adverse Events for TERN-101 Versus Placebo
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in ALT Outcome Measure
Time Frame: 12 weeks
12 weeks
Plasma Concentration of TERN-101 - AUC 0-24
Time Frame: 12 weeks (0-24 hours post dose)
Area under the curve
12 weeks (0-24 hours post dose)
Plasma Concentration of TERN-101 - Cmax
Time Frame: 12 Weeks (0-72 hours post dose)
Maximum observed concentration
12 Weeks (0-72 hours post dose)
Plasma Concentration of TERN-101 - Tmax
Time Frame: 12 Weeks (0-72 hours post dose)
Time to reach maximum measured plasma concentration
12 Weeks (0-72 hours post dose)
Plasma Concentration of TERN-101 - t1/2
Time Frame: 12 Weeks (0-72 hours post dose)
Determination of half-life
12 Weeks (0-72 hours post dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Terns, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: clinicaltrials@ternspharma.com, Terns, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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