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Empagliflozin for Non-alcoholic Fatty Liver Disease

Phase 2
Waitlist Available
Research Sponsored by Metacrine, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days after last dose
Awards & highlights

Study Summary

This study is evaluating whether a drug which is used to treat type 2 diabetes may help treat a type of cancer.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease
  • Fatty Liver Disease
  • Nonalcoholic Steatohepatitis
  • Type 2 Diabetes
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days after last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of MET409 with or without empagliflozin (incidence of adverse events)
Secondary outcome measures
Pharmacodynamic profile of MET409 alone or in combination with empagliflozin
Gene Expression Profiling
Pharmacological activity of MET409 alone or in combination with empagliflozin

Side effects data

From 2021 Phase 3 trial • 5988 Patients • NCT03057951
15%
Cardiac failure
7%
Hypertension
7%
Urinary tract infection
7%
Hypotension
6%
Hyperkalaemia
6%
Fall
6%
Renal impairment
5%
Atrial fibrillation
5%
Diabetes mellitus
4%
Anaemia
4%
Hyperuricaemia
3%
Acute kidney injury
3%
Pneumonia
2%
Acute myocardial infarction
2%
COVID-19
2%
Cardiac failure congestive
2%
Death
1%
Cardiac failure chronic
1%
Myocardial infarction
1%
Angina pectoris
1%
Angina unstable
1%
Ventricular tachycardia
1%
COVID-19 pneumonia
1%
Cellulitis
1%
Sepsis
1%
Chronic kidney disease
1%
Coronary artery disease
1%
Chronic obstructive pulmonary disease
1%
Basal cell carcinoma
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Syncope
1%
Transient ischaemic attack
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Empagliflozin

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: MET409A +Open-Label EmpagliflozinExperimental Treatment2 Interventions
MET409 Active (50mg) + Empagliflozin (10mg)
Group II: MET409 AExperimental Treatment1 Intervention
MET409 Active (50mg)
Group III: MET409P +Open-Label EmpagliflozinPlacebo Group2 Interventions
MET409 Placebo (50mg) + Empagliflozin (10mg)
Group IV: MET409 PPlacebo Group1 Intervention
MET409 Placebo (50mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin
FDA approved

Find a Location

Who is running the clinical trial?

Metacrine, Inc.Lead Sponsor
1 Previous Clinical Trials
215 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
215 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Hubert C Chen, MDStudy ChairMetacrine, Inc.
3 Previous Clinical Trials
218 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate MET409 Alone or in Combination With Empagliflozin in Patients With Type 2 Diabetes and NASH
2020. "Study to Evaluate MET409 Alone or in Combination With Empagliflozin in Patients With Type 2 Diabetes and NASH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04702490.
All > Nash > Type 2 Diabetes
~28 spots leftby Apr 2025
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