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Study to Evaluate MET642 in Patients With 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04773964
Recruitment Status : Active, not recruiting
First Posted : February 26, 2021
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
Metacrine, Inc.

Study Description
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Brief Summary:
A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Drug: MET642 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2a Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MET642 in Patients With Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : March 3, 2021
Estimated Primary Completion Date : January 17, 2022
Estimated Study Completion Date : February 14, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MET642 high dose Drug: MET642
MET642 active treatment
Experimental: MET642 low dose Drug: MET642
MET642 active treatment
Placebo Comparator: MET642 Placebo Drug: Placebo
Placebo comparator


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 28 days after last dose ]
    Incidences of treatment-emergent adverse events

  2. Vital Signs [ Time Frame: Up to 28 days after last dose ]
    Incidences of clinically significant changes in vital signs

  3. Laboratory tests [ Time Frame: Up to 28 days after last dose ]
    Incidences of clinically significant changes in laboratory tests

  4. ECG [ Time Frame: Up to 28 days after last dose ]
    Incidences of clinically significant changes in ECGs


Secondary Outcome Measures :
  1. Pharmacokinetic Profile of MET642 [ Time Frame: 16 weeks ]
    Cmax

  2. Pharmacodynamic Profile of MET642 [ Time Frame: 16 weeks ]
    C4 concentrations

  3. Pharmacological Activity of MET642 [ Time Frame: 20 weeks ]
    Measure of changes in liver fat using MRI-PDFF

  4. Pharmacokinetic Profile of MET642 [ Time Frame: 16 weeks ]
    Tmax

  5. Pharmacokinetic Profile of MET642 [ Time Frame: 16 weeks ]
    T1/2

  6. Pharmacokinetic Profile of MET642 [ Time Frame: 16 weeks ]
    AUC0-inf

  7. Pharmacodynamic Profile of MET642 [ Time Frame: 16 weeks ]
    FGF19 concentrations

  8. Pharmacodynamic Profile of MET642 [ Time Frame: 16 weeks ]
    Bile Acids concentrations


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

Inclusion Criteria:

  • Diagnosis of NASH via biopsy, magnetic resonance elastography (MRE), or transient elastography (TE, FibroScan)
  • Liver fat content ≥ 10% as measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).

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.
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): NCT04773964


Locations
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United States, Texas
Pinnacle Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Metacrine, Inc.
More Information
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Additional Information:

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Responsible Party: Metacrine, Inc.
ClinicalTrials.gov Identifier: NCT04773964    
Other Study ID Numbers: MET642-201
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 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
Fatty Liver
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases