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NCT04328077 Clinical Trial

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

NASH - Nonalcoholic Steatohepatitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04328077
Other study ID # TERN101-2001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 18, 2020
Est. completion date May 19, 2021

Study information
Verified date July 2022
Source Terns, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date May 19, 2021
Est. primary completion date May 19, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• TERN-101
Investigational drug
Other:
• Placebo
Matching placebo

Locations
Country Name City State
United States Terns Clinical Study Site 1005 Arlington Texas
United States Terns Clinical Study Site 1002 Baltimore Maryland
United States Terns Clinical Study Site 1010 Bastrop Louisiana
United States Terns Clinical Study Site 1011 Boston Massachusetts
United States Terns Clinical Study Site 1017 Chandler Arizona
United States Terns Clinical Study Site 1004 Coronado California
United States Terns Clinical Study Site 1027 Durham North Carolina
United States Terns Clinical Study Site 1038 Florham Park New Jersey
United States Terns Clinical Study Site 1035 Fresno California
United States Terns Clinical Study Site 1012 Gainesville Florida
United States Terns Clinical Study Site 1025 Georgetown Texas
United States Terns Clinical Study Site 1014 Hermitage Tennessee
United States Terns Clinical Study Site 1007 Hialeah Florida
United States Terns Clinical Study Site 1028 Hialeah Florida
United States Terns Clinical Study Site 1021 Houston Texas
United States Terns Clinical Study Site 1029 Houston Texas
United States Terns Clinical Study Site 1032 Indianapolis Indiana
United States Terns Clinical Study Site 1013 La Jolla California
United States Terns Clinical Study Site 1016 Los Angeles California
United States Terns Clinical Study Site 1009 Miami Florida
United States Terns Clinical Study Site 1008 Montclair California
United States Terns Clinical Study Site 1037 New Orleans Louisiana
United States Terns Clinical Study Site 1033 Orlando Florida
United States Terns Clinical Study Site 1001 Panorama City California
United States Terns Clinical Study Site 1003 San Antonio Texas
United States Terns Clinical Study Site 1006 San Antonio Texas
United States Terns Clinical Study Site 1019 San Antonio Texas
United States Terns Clinical Study Site 1022 Seattle Washington
United States Terns Clinical Study Site 1023 Shreveport Louisiana
United States Terns Clinical Study Site 1018 Tucson Arizona
United States Terns Clinical Study Site 1024 Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Terns, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events for TERN-101 Versus Placebo 16 weeks
Secondary Percent Change From Baseline in ALT Outcome Measure 12 weeks
Secondary Plasma Concentration of TERN-101 - AUC 0-24 Area under the curve 12 weeks (0-24 hours post dose)
Secondary Plasma Concentration of TERN-101 - Cmax Maximum observed concentration 12 Weeks (0-72 hours post dose)
Secondary Plasma Concentration of TERN-101 - Tmax Time to reach maximum measured plasma concentration 12 Weeks (0-72 hours post dose)
Secondary Plasma Concentration of TERN-101 - t1/2 Determination of half-life 12 Weeks (0-72 hours post dose)
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