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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Drug: TERN-101
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TERN-101 dose level 1<br>Orally administered. | Drug: TERN-101<br>* Investigational drug<br>|
| Experimental: TERN-101 dose level 2<br>Orally administered. | Drug: TERN-101<br>* Investigational drug<br>|
| Experimental: TERN-101 dose level 3<br>Orally administered. | Drug: TERN-101<br>* Investigational drug<br>|
| Placebo Comparator: Placebo<br>Orally administered. | Other: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Farnesoid X receptor, NASH, Nonalcoholic Steatohepatitis, NAFLD, Nonalcoholic Fatty Liver Disease, FXR