Skip to main content
OpenTrials
Completed

NCT Number: NCT04328077

LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

NASH - Nonalcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Terns Clinical Study Site 1017, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TERN-101

Drug

Investigational drug

Placebo

Other

Matching placebo

Primary outcomes

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

    Time frame: 16 weeks

Secondary outcomes

  1. Percent Change From Baseline in ALT Outcome Measure

    Time frame: 12 weeks

  2. Plasma Concentration of TERN-101 - AUC 0-24

    Time frame: 12 weeks (0-24 hours post dose)

    Area under the curve

  3. Plasma Concentration of TERN-101 - Cmax

    Time frame: 12 Weeks (0-72 hours post dose)

    Maximum observed concentration

  4. Plasma Concentration of TERN-101 - Tmax

    Time frame: 12 Weeks (0-72 hours post dose)

    Time to reach maximum measured plasma concentration

  5. Plasma Concentration of TERN-101 - t1/2

    Time frame: 12 Weeks (0-72 hours post dose)

    Determination of half-life

Sponsors and collaborators

Lead sponsor

Terns, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2020
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.