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Study to Evaluate MET409 Alone or in Combination With Empagliflozin in Patients With Type 2 Diabetes and NASH | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

A Phase 2A Study to Evaluate MET409 Alone or in Combination With Empagliflozin in Patients With Type 2 Diabetes Mellitus (T2DM) and Nonalcoholic Steatohepatitis (NASH)

NCT04702490•Metacrine, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Metacrine Investigative Site

Fort Myers, Florida, United States

Metacrine Investigative Site

San Antonio, Texas, United States

Key Dates

Start Date

December 15, 2020

Primary Completion Date

April 1, 2022

Completion Date

June 1, 2022

Last Updated

June 1, 2021

Enrollment

120

ACTUAL participants

Conditions

NASHNASH - Nonalcoholic SteatohepatitisType 2 DiabetesDiabetes Type 2DiabetesFatty LiverFatty Liver, NonalcoholicNAFLD

Interventions

MET409 Active

DRUG

MET409 Placebo

DRUG

Empagliflozin

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 1, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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