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Empagliflozin for Non-alcoholic Fatty Liver Disease (NAFLD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Tandem Clinical Research - New Orleans Area Site, Marrero, LANon-alcoholic Fatty Liver Disease (NAFLD)+1 MoreEmpagliflozin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will test the effect of the drug lanifibranor on diabetes control in patients also taking an SGLT2 inhibitor.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)
  • Type 2 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Empagliflozin
1
Miricorilant Dose Escalation
1
Miricorilant - Fluvoxamine/Miricorilant

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Date of randomisation until the end of treatment at week 24

Week 24
Assessment of the effect of lanifibranor alone compared to placebo and the effect of lanifibranor in combination with empagliflozin compared to placebo on absolute change in HbA1c from baseline (Week 0) to Week 24

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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1
Empagliflozin
1
Miricorilant Dose Escalation
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Miricorilant - Fluvoxamine/Miricorilant

Side Effects for

10 mg Empagliflozin
15%Cardiac failure
7%Hypertension
7%Hypotension
7%Urinary tract infection
6%Hyperkalaemia
6%Renal impairment
6%Fall
5%Diabetes mellitus
5%Atrial fibrillation
4%Hyperuricaemia
4%Anaemia
3%Pneumonia
3%Acute kidney injury
2%Death
2%Cardiac failure congestive
2%Acute myocardial infarction
2%COVID-19
1%Syncope
1%Chronic obstructive pulmonary disease
1%Myocardial infarction
1%Angina pectoris
1%Cardiac failure chronic
1%Chronic kidney disease
1%Angina unstable
1%Cerebrovascular accident
1%Ischaemic stroke
1%Transient ischaemic attack
1%Coronary artery disease
1%Ventricular tachycardia
1%COVID-19 pneumonia
1%Sepsis
1%Basal cell carcinoma
1%Cellulitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03057951) in the 10 mg Empagliflozin ARM group. Side effects include: Cardiac failure with 15%, Hypertension with 7%, Hypotension with 7%, Urinary tract infection with 7%, Hyperkalaemia with 6%.

Trial Design

3 Treatment Groups

Lanifibranor (IVA337) (800 mg/day)
1 of 3
Lanifibranor (IVA337) (800 mg/day) plus Empagliflozin (10mg/day)
1 of 3
Matching placebo
1 of 3

Experimental Treatment

Non-Treatment Group

63 Total Participants · 3 Treatment Groups

Primary Treatment: Empagliflozin · Has Placebo Group · Phase 2

Lanifibranor (IVA337) (800 mg/day)
Drug
Experimental Group · 1 Intervention: IVA337 · Intervention Types: Drug
Lanifibranor (IVA337) (800 mg/day) plus Empagliflozin (10mg/day)Experimental Group · 2 Interventions: IVA337, Empagliflozin · Intervention Types: Drug, Drug
Matching placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IVA337
2015
Completed Phase 2
~400
Empagliflozin
2017
Completed Phase 4
~102500

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: date of randomisation until the end of treatment at week 24

Who is running the clinical trial?

Inventiva PharmaLead Sponsor
6 Previous Clinical Trials
2,502 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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References

Frequently Asked Questions

Are there any current vacancies for people who might want to participate in this research?

"The trial you are inquiring about is still recruiting patients, according to the latest information on clinicaltrials.gov. This particular study was posted on 6/29/2022 and updated on 11/3/2022." - Anonymous Online Contributor

Unverified Answer

What is the regulatory status of Empagliflozin?

"Empagliflozin's safety was rated a 2 because, while there is some data supporting its safety profile, there is no evidence yet of the drug's efficacy." - Anonymous Online Contributor

Unverified Answer

At how many different geographical locations is this trial taking place?

"There are a total of 14 sites running this clinical trial, which include locations such as the National Research Institute in Huntington Park, Cadena Care Institute in Poway, and Central Virginia VA Healthcare System in Richmond." - Anonymous Online Contributor

Unverified Answer

How many people are included in this trial?

"In order to complete this study, 63 eligible patients must be recruited. Inventiva Pharma will manage the trial from their facility in Huntington Park, California as well as Cadena Care Institute in Poway, Virginia." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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