NCT04773964

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

March 3, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 28, 2024

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

February 19, 2021

Last Update Submit

March 26, 2024

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

NASHFatty Liver

Outcome Measures

Primary Outcomes (4)

  • Adverse Events

    Incidences of treatment-emergent adverse events

    Up to 28 days after last dose

  • Vital Signs

    Incidences of clinically significant changes in vital signs

    Up to 28 days after last dose

  • Laboratory tests

    Incidences of clinically significant changes in laboratory tests

    Up to 28 days after last dose

  • ECG

    Incidences of clinically significant changes in ECGs

    Up to 28 days after last dose

Secondary Outcomes (8)

  • Pharmacokinetic Profile of MET642

    16 weeks

  • Pharmacodynamic Profile of MET642

    16 weeks

  • Pharmacological Activity of MET642

    20 weeks

  • Pharmacokinetic Profile of MET642

    16 weeks

  • Pharmacokinetic Profile of MET642

    16 weeks

  • +3 more secondary outcomes

Study Arms (3)

MET642 high dose

EXPERIMENTAL
Drug: MET642

MET642 low dose

EXPERIMENTAL
Drug: MET642

MET642 Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MET642DRUG

MET642 active treatment

MET642 high doseMET642 low dose
PlaceboDRUG

Placebo comparator

MET642 Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pinnacle Research

San Antonio, Texas, 78229, United States

Location

Related Links

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseFatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 26, 2021

Study Start

March 3, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 28, 2024

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)