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MET642

Phase 2

NASH - Nonalcoholic Steatohepatitis | Small molecule | Metabolic |Equillium, Inc.|Trials Updated: Mar 28, 2024

MET642 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Feb 2021

MET642 target and mechanism

Molecular targetFXR
Target classReceptor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment215

FDA Designations

No designations recorded

MET642 clinical trials

MET642 · 1 trial · 1 indication

Phase 2 1
NCT04773964Study to Evaluate MET642 in Patients With NASHNASH - Nonalcoholic Steatohepatitis
COMPLETED215 Analytics
PHASE2COMPLETED
Study to Evaluate MET642 in Patients With NASH
NASH - Nonalcoholic SteatohepatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Events
Up to 28 days after last dose

Incidences of treatment-emergent adverse events

Vital Signs
Up to 28 days after last dose

Incidences of clinically significant changes in vital signs

Laboratory tests
Up to 28 days after last dose

Incidences of clinically significant changes in laboratory tests

ECG
Up to 28 days after last dose

Incidences of clinically significant changes in ECGs

Secondary Endpoints

Pharmacokinetic Profile of MET642
16 weeks
Pharmacodynamic Profile of MET642
16 weeks
Pharmacological Activity of MET642
20 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MET642 high doseEXPERIMENTAL -
MET642 low doseEXPERIMENTAL -
MET642 PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
MET642DRUGMET642 active treatment
PlaceboDRUGPlacebo comparator
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 disea...

Countries:United States
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Frequently asked questions about MET642

What is MET642 used for?

MET642 is an investigational small molecule being developed for nonalcoholic steatohepatitis, or NASH, a metabolic liver disease. It has been studied in a Phase 2 clinical trial in patients with NASH. MET642 is not approved for any indication and remains in clinical development.

What does MET642 target?

MET642 targets FXR, the farnesoid X receptor. FXR is a nuclear receptor that regulates bile acid, lipid, and glucose metabolism, which is why it is being explored as a therapeutic target in NASH. MET642 is a small molecule designed to act on this receptor.

Who is developing MET642?

MET642 is being developed by Equillium, Inc., which trades under the ticker EQ. Equillium is the sponsor of the clinical program evaluating MET642 in NASH.

What phase is MET642 in?

MET642 is in Phase 2 development. A Phase 2 study in patients with NASH has been completed. MET642 is investigational and has not been approved by the FDA for any indication.

What clinical trials is MET642 in?

MET642 has been evaluated in one clinical trial, NCT04773964, titled Study to Evaluate MET642 in Patients With NASH. This completed Phase 2 trial enrolled 215 patients in the United States, was randomized, double-blind, and placebo-controlled, and included patients aged 18 years and older.