Study to Evaluate MET409 Alone or in Combination With Empagliflozin in Patients With Type 2 Diabetes and NASH

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, multi-center study evaluating MET409 (50 mg) alone or in combination with empagliflozin (10 mg) for 12 weeks. Assignment to MET409 will be double-blind and placebo-controlled. Empagliflozin will be incorporated into two of the treatment arms in an open-label manner.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Metacrine, Inc.
• Treatments: Empagliflozin

Criteria

Key Inclusion Criteria:

• Males and females 18 through 75 years of age.

• Diagnosis of NASH based on NAFLD Activity Score (NAS) ≥ 4 with at least 1 point in each of steatosis, inflammation, and ballooning; Magnetic Resonance Elastography (MRE) showing kPa ≥ 2.61 or a multiparametric MRI (ie, LiverMultiScan) showing iron-corrected T1(cT1) > 830 ms within 6 months of enrollment; or Transient elastography (TE, FibroScan) with liver stiffness ≥ 8.5 kPa and controlled attenuation parameter (CAP) > 300 dB/m obtained within 3 months of enrollment.

• Liver fat content ≥ 8% measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) during screening.

• Diagnosis of T2DM for ≤ 10 years, with hemoglobin A1c ≤ 10.0% during screening, stable and controlled with diet or treatment for at least 3 months.

Key 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.

• Use of any insulin (injectable or inhaled), SGLT-2 inhibitor or glucagon-like peptide 1 (GLP-1, injectable or oral) products for > 7 days within 3 months of screening.

• Weight loss > 10% in the 6 months prior to screening or > 5% during screening.

• Use of drugs historically associated with causing NAFLD for more than 4 consecutive weeks within 12 months prior to screening.

• Concomitant use of drugs that are strong or moderate CYP3A4 inhibitors.

• Concomitant consumption of grapefruit juice with the study drug.

• History of diabetic ketoacidosis (DKA) within 1 month prior to the Screening Visit, or more than 2 episodes within 6 months prior to the Screening Visit.

• History of > 2 episodes of urosepsis or pyelonephritis within 5 years of screening.