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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04702490
Other study ID # MET409-201
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 15, 2020
Est. completion date June 2022

Study information

Verified date May 2021
Source Metacrine, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date June 2022
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MET409 Active
MET409 Active (50mg)
MET409 Placebo
MET409 Placebo (50mg)
Empagliflozin
Empagliflozin (10mg)

Locations

Country Name City State
United States Metacrine Investigative Site Fort Myers Florida
United States Metacrine Investigative Site San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Metacrine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability of MET409 with or without empagliflozin (incidence of adverse events) Incidence of Treatment-emergent adverse events, incidence of clinically significant changes in vital signs, abnormal laboratory safety tests, and abnormal ECGs. Up to 28 days after last dose
Secondary Pharmacological activity of MET409 alone or in combination with empagliflozin Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) 16 weeks
Secondary Pharmacokinetic profile of MET409 alone or in combination with empagliflozin Cmax 12 weeks
Secondary Pharmacokinetic profile of MET409 alone or in combination with empagliflozin tmax 12 weeks
Secondary Pharmacokinetic profile of MET409 alone or in combination with empagliflozin AUClast 12 weeks
Secondary Pharmacodynamic profile of MET409 alone or in combination with empagliflozin Bile acid precursor : C4 (7ahydroxy-4-cholesten-3-one) 16 weeks
Secondary Pharmacodynamic profile of MET409 alone or in combination with empagliflozin Bile acid precursor : Fibroblast growth factor 19 (FGF19) 16 weeks
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