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Empagliflozin for 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
Approved for 10 Other Conditions
All Individual Drugs Already Approved

Summary

This trial tests a new drug, MET409, alone or with empagliflozin, which helps lower blood sugar. It targets patients needing better blood sugar control. MET409's effectiveness is being evaluated, while empagliflozin works by removing sugar through urine.

Eligible Conditions
  • Fatty Liver Disease
  • Nonalcoholic fatty liver disease
  • Non-alcoholic Fatty Liver Disease
  • 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and tolerability of MET409 with or without empagliflozin (incidence of adverse events)
Secondary study objectives
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%
Hypotension
7%
Urinary tract infection
6%
Renal impairment
6%
Hyperkalaemia
6%
Fall
5%
Atrial fibrillation
5%
Diabetes mellitus
4%
Hyperuricaemia
4%
Anaemia
3%
Acute kidney injury
3%
Pneumonia
2%
COVID-19
2%
Death
2%
Acute myocardial infarction
2%
Cardiac failure congestive
1%
Cardiac failure chronic
1%
Cellulitis
1%
Syncope
1%
Chronic kidney disease
1%
COVID-19 pneumonia
1%
Ischaemic stroke
1%
Coronary artery disease
1%
Basal cell carcinoma
1%
Chronic obstructive pulmonary disease
1%
Myocardial infarction
1%
Sepsis
1%
Transient ischaemic attack
1%
Angina unstable
1%
Cerebrovascular accident
1%
Angina pectoris
1%
Ventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Empagliflozin

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
Hubert C Chen, MDStudy ChairMetacrine, Inc.
3 Previous Clinical Trials
218 Total Patients Enrolled
~24 spots leftby Dec 2025
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