DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis

Terns Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Drug: TERN-101; Other: Placebo; Drug: TERN-501

Study type: Interventional

Funder types: Industry

Identifiers

NCT05415722

TERNCB-2002

Details and patient eligibility

About

This is a Phase 2a Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with Presumed Non-Alcoholic Steatohepatitis (NASH)

Enrollment: 162 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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 diagnosed by prior biopsy and/or imaging criteria
• Written informed consent

Key Exclusion Criteria:

• History or clinical evidence of chronic liver diseases other than NAFLD
• History or known clinical evidence of cirrhosis, esophageal varices, hepatic decompensation or other severe liver impairment,
• History of liver transplant, or current placement on a liver transplant list
• Current diagnosis or history of pituitary or thyroid disorders - except for patients with primary hypothyroidism on a stable dose of thyroid hormone replacement therapy.
• Abnormal TSH or free T4 levels
• Weight loss of > 5% total body weight within 3 months prior to Screening
• Uncontrolled diabetes
• Uncontrolled hyperlipidemia
• Unstable cardiovascular disease
• Excessive alcohol consumption

Other protocol-defined I/E criteria that apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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162 participants in 7 patient groups, including a placebo group

Arm 1: TERN-501 1 mg

Experimental group

Description:

Orally administered.

Treatment:

Drug: TERN-501

Arm 2: TERN-501 3 mg

Experimental group

Description:

Orally administered.

Treatment:

Drug: TERN-501

Arm 3: TERN-501 6 mg

Experimental group

Description:

Orally administered.

Treatment:

Drug: TERN-501

Arm 4: TERN-501 3 mg + TERN-101 10 mg

Experimental group

Description:

Orally administered.

Treatment:

Drug: TERN-501

Drug: TERN-101

Arm 5: TERN-501 6 mg + TERN-101 10 mg

Experimental group

Description:

Orally administered.

Treatment:

Drug: TERN-501

Drug: TERN-101

Arm 6:TERN-101 10 mg

Experimental group

Description:

Orally administered.

Treatment:

Drug: TERN-101

Arm 7: Matching placebo

Placebo Comparator group

Description:

Orally administered.

Treatment:

Other: Placebo