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

NCT ID: NCT04702490

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2022-06-30

Brief 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.

Detailed Description

Subjects assigned to receive empagliflozin will be dosed at 10 mg per day for the duration of the study.

Approximately 30 subjects will be enrolled per treatment arm.

Conditions

NASH; NASH - Nonalcoholic Steatohepatitis; Type 2 Diabetes; Diabetes Type 2; Diabetes; Fatty Liver; Fatty Liver, Nonalcoholic; NAFLD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MET409 A

MET409 Active (50mg)

Group Type: EXPERIMENTAL

MET409 Active

Intervention Type: DRUG

MET409 Active (50mg)

MET409 P

MET409 Placebo (50mg)

Group Type: PLACEBO_COMPARATOR

MET409 Placebo

Intervention Type: DRUG

MET409 Placebo (50mg)

MET409A +Open-Label Empagliflozin

MET409 Active (50mg) + Empagliflozin (10mg)

Group Type: EXPERIMENTAL

MET409 Active

Intervention Type: DRUG

MET409 Active (50mg)

Empagliflozin

Intervention Type: DRUG

Empagliflozin (10mg)

MET409P +Open-Label Empagliflozin

MET409 Placebo (50mg) + Empagliflozin (10mg)

Group Type: PLACEBO_COMPARATOR

MET409 Placebo

Intervention Type: DRUG

MET409 Placebo (50mg)

Empagliflozin

Intervention Type: DRUG

Empagliflozin (10mg)

Interventions

MET409 Active

MET409 Active (50mg)

Intervention Type: DRUG

MET409 Placebo

MET409 Placebo (50mg)

Intervention Type: DRUG

Empagliflozin

Empagliflozin (10mg)

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Metacrine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hubert C Chen, MD

Role: STUDY_CHAIR

Metacrine, Inc.

Locations

Metacrine Investigative Site

Fort Myers, Florida, United States

Metacrine Investigative Site

San Antonio, Texas, United States

Countries

United States

Other Identifiers

MET409-201

Identifier Type: -

Identifier Source: org_study_id