Skip to main content
OpenTrials
Completed

NCT Number: NCT04773964

Study to Evaluate MET642 in Patients With NASH

A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

NASH - Nonalcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pinnacle Research

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MET642

Drug

MET642 active treatment

Placebo

Drug

Placebo comparator

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Metacrine, Inc.

Industry

Registry information

Official study title

Phase 2a Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MET642 in Patients With Nonalcoholic Steatohepatitis (NASH)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2021
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.