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

Terns Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Other: Placebo; Drug: TERN-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT04328077

TERN101-2001

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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101 participants in 4 patient groups, including a placebo group

TERN-101 dose level 1

Experimental group

Description:

Orally administered.

Treatment:

Drug: TERN-101

TERN-101 dose level 2

Experimental group

Description:

Orally administered.

Treatment:

Drug: TERN-101

TERN-101 dose level 3

Experimental group

Description:

Orally administered.

Treatment:

Drug: TERN-101

Placebo

Placebo Comparator group

Description:

Orally administered.

Treatment:

Other: Placebo