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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04702490
Recruitment Status : Recruiting
First Posted : January 11, 2021
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Metacrine, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
NASH NASH - Nonalcoholic Steatohepatitis Type 2 Diabetes Diabetes Type 2 Diabetes Fatty Liver Fatty Liver, Nonalcoholic NAFLD Drug: MET409 Active Drug: MET409 Placebo Drug: Empagliflozin Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MET409 A
MET409 Active (50mg)
 Drug: MET409 Active
MET409 Active (50mg)
Placebo Comparator: MET409 P
MET409 Placebo (50mg)
 Drug: MET409 Placebo
MET409 Placebo (50mg)
Experimental: MET409A +Open-Label Empagliflozin
MET409 Active (50mg) + Empagliflozin (10mg)
 Drug: MET409 Active
MET409 Active (50mg)

Drug: Empagliflozin
Empagliflozin (10mg)
Placebo Comparator: MET409P +Open-Label Empagliflozin
MET409 Placebo (50mg) + Empagliflozin (10mg)
 Drug: MET409 Placebo
MET409 Placebo (50mg)

Drug: Empagliflozin
Empagliflozin (10mg)


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of MET409 with or without empagliflozin (incidence of adverse events) [ Time Frame: Up to 28 days after last dose ]
    Incidence of Treatment-emergent adverse events, incidence of clinically significant changes in vital signs, abnormal laboratory safety tests, and abnormal ECGs.


Secondary Outcome Measures :
  1. Pharmacological activity of MET409 alone or in combination with empagliflozin [ Time Frame: 16 weeks ]
    Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)

  2. Pharmacokinetic profile of MET409 alone or in combination with empagliflozin [ Time Frame: 12 weeks ]
    Cmax

  3. Pharmacokinetic profile of MET409 alone or in combination with empagliflozin [ Time Frame: 12 weeks ]
    tmax

  4. Pharmacokinetic profile of MET409 alone or in combination with empagliflozin [ Time Frame: 12 weeks ]
    AUClast

  5. Pharmacodynamic profile of MET409 alone or in combination with empagliflozin [ Time Frame: 16 weeks ]
    Bile acid precursor : C4 (7αhydroxy-4-cholesten-3-one)

  6. Pharmacodynamic profile of MET409 alone or in combination with empagliflozin [ Time Frame: 16 weeks ]
    Bile acid precursor : Fibroblast growth factor 19 (FGF19)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04702490


Contacts
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Contact: Brian Byrnes (858) 369-7800 bbyrnes@metacrine.com

Locations
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United States, Florida
Metacrine Investigative Site Recruiting
Fort Myers, Florida, United States, 33907
Contact: Site 103         
United States, Texas
Metacrine Investigative Site Recruiting
San Antonio, Texas, United States, 78215
Contact: Site 101         
Sponsors and Collaborators
Metacrine, Inc.
Investigators
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Study Chair: Hubert C Chen, MD Metacrine, Inc.
More Information
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Additional Information:

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Responsible Party: Metacrine, Inc.
ClinicalTrials.gov Identifier: NCT04702490    
Other Study ID Numbers: MET409-201
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Metacrine, Inc.:
NASH
FXR
Fatty Liver
Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Fatty Liver
Non-alcoholic Fatty Liver Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Liver Diseases
Digestive System Diseases
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs