NASH - Nonalcoholic SteatohepatitisPhase 2NCT04773964
Study to Evaluate MET642 in Patients With NASH
A Phase 2 study testing MET642 in people with NASH - Nonalcoholic Steatohepatitis, run by Metacrine, Inc. at 1 site in United States.
Trial summary
A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- MET642
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2021to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2a Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MET642 in Patients With Nonalcoholic Steatohepatitis (NASH)
A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- MET642, Placebo
- Keywords
- NASH, Fatty Liver
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MET642Drug
MET642 active treatment
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| MET642 high dose | Experimental | Not described Receives: Drug: MET642 |
| MET642 low dose | Experimental | Not described Receives: Drug: MET642 |
| MET642 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidences of treatment-emergent adverse events
Measured: Up to 28 days after last dose
Vital Signs
Incidences of clinically significant changes in vital signs
Measured: Up to 28 days after last dose
Laboratory tests
Incidences of clinically significant changes in laboratory tests
Measured: Up to 28 days after last dose
ECG
Incidences of clinically significant changes in ECGs
Measured: Up to 28 days after last dose
Secondary outcomes (8)
Pharmacokinetic Profile of MET642
Cmax
Measured: 16 weeks
Pharmacodynamic Profile of MET642
C4 concentrations
Measured: 16 weeks
Pharmacological Activity of MET642
Measure of changes in liver fat using MRI-PDFF
Measured: 20 weeks
Pharmacokinetic Profile of MET642
Tmax
Measured: 16 weeks
Pharmacokinetic Profile of MET642
T1/2
Measured: 16 weeks
Pharmacokinetic Profile of MET642
AUC0-inf
Measured: 16 weeks
Pharmacodynamic Profile of MET642
FGF19 concentrations
Measured: 16 weeks
Pharmacodynamic Profile of MET642
Bile Acids concentrations
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start3 Mar 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metacrine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773964
- Sponsor's protocol ID
- MET642-201
- Status last verified
- Sep 2021
- First submitted
- 19 Feb 2021
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MET642 in Patients With Nonalcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT04773964
- Acronym / sponsor ID
- MET642-201
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Keywords
- NASH, Fatty Liver
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Metacrine, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MET642 high dose | Experimental | Drug: MET642 |
| MET642 low dose | Experimental | Drug: MET642 |
| MET642 Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MET642MET642 active treatment | Drug | MET642 high dose, MET642 low dose |
| PlaceboPlacebo comparator | Drug | MET642 Placebo |
Primary outcome
Adverse Events
Time frame: Up to 28 days after last dose
Incidences of treatment-emergent adverse events
Vital Signs
Time frame: Up to 28 days after last dose
Incidences of clinically significant changes in vital signs
Laboratory tests
Time frame: Up to 28 days after last dose
Incidences of clinically significant changes in laboratory tests
ECG
Time frame: Up to 28 days after last dose
Incidences of clinically significant changes in ECGs
8 secondary outcomes
Pharmacokinetic Profile of MET642
Time frame: 16 weeks
Pharmacodynamic Profile of MET642
Time frame: 16 weeks
Pharmacological Activity of MET642
Time frame: 20 weeks
Pharmacokinetic Profile of MET642
Time frame: 16 weeks
Pharmacokinetic Profile of MET642
Time frame: 16 weeks
Pharmacokinetic Profile of MET642
Time frame: 16 weeks
Pharmacodynamic Profile of MET642
Time frame: 16 weeks
Pharmacodynamic Profile of MET642
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Metacrine websiteLink provided by the sponsor.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MET642 in people with NASH - Nonalcoholic Steatohepatitis, run by Metacrine, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Up to 28 days after last dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.