Study to Evaluate MET642 in Patients With NASH

Metacrine

Status and phase: Completed; Phase 2

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Drug: Placebo; Drug: MET642

Study type: Interventional

Funder types: Industry

Identifiers

NCT04773964

MET642-201

Details and patient eligibility

About

A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.

Enrollment: 215 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of NASH via biopsy, magnetic resonance elastography (MRE), or transient elastography (TE, FibroScan)
• Liver fat content ≥ 10% as measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).

Exclusion criteria

• History of significant liver disease (eg, alcoholic liver disease, viral hepatitis, etc.) or liver transplant.
• Presence of cirrhosis on any prior liver biopsy (stage 4 fibrosis).
• Excessive consumption of alcohol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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215 participants in 3 patient groups, including a placebo group

MET642 high dose

Experimental group

Treatment:

Drug: MET642

MET642 low dose

Experimental group

Treatment:

Drug: MET642

MET642 Placebo

Placebo Comparator group

Treatment:

Drug: Placebo