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PPAR agonist

Lanifibranor + Empagliflozin for Type 2 Diabetes (LEGEND Trial)

Phase 2
Waitlist Available
Research Sponsored by Inventiva Pharma
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 date of randomisation until the end of treatment at week 24

Summary

This trial is testing a new drug called lanifibranor to see if it can help people with Type 2 Diabetes control their blood sugar levels. It also looks at how well lanifibranor works when combined with another drug that helps remove sugar from the body through urine. The goal is to find better ways to manage blood sugar for people who struggle with current treatments.

Who is the study for?
Adults with NASH and Type 2 Diabetes Mellitus, HbA1c between 7.0-10.0%, stable on certain diabetes medications or diet alone can join this trial. Exclusions include recent participation in other trials, severe illnesses, specific medication use affecting glucose tolerance, uncontrolled hypertension, high BMI (>45), liver cirrhosis or cancer, significant alcohol consumption within the last 5 years.
What is being tested?
The study tests lanifibranor's effects on blood sugar control against a placebo and examines if combining it with an SGLT2 inhibitor (Empagliflozin) improves outcomes for diabetic patients with NASH.
What are the potential side effects?
Potential side effects may include typical drug reactions like nausea, headaches or allergic responses; however specific side effects of Lanifibranor and Empagliflozin are not detailed here.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of randomisation until the end of treatment at week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and date of randomisation until the end of treatment at week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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

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%
Basal cell carcinoma
1%
Cardiac failure chronic
1%
Cellulitis
1%
Syncope
1%
Chronic kidney disease
1%
COVID-19 pneumonia
1%
Ischaemic stroke
1%
Coronary artery disease
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

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Lanifibranor (IVA337) (800 mg/day) plus Empagliflozin (10mg/day)Experimental Treatment2 Interventions
2 Lanifibranor tablets 400 mg plus 1 Empagliflozin tablet 10mg with food --\> once a day (quaque die, QD)
Group II: Lanifibranor (IVA337) (800 mg/day)Experimental Treatment1 Intervention
2 Lanifibranor tablets 400 mg with food --\> once a day (quaque die, QD)
Group III: Matching placeboPlacebo Group1 Intervention
2 Placebo to match tablets with food --\> once a day (quaque die, QD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IVA337
2015
Completed Phase 2
~440
Empagliflozin
2017
Completed Phase 4
~181750

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include Pan-PPAR agonists like Lanifibranor, which target multiple PPAR subtypes to regulate lipid metabolism, inflammation, and insulin sensitivity. This is crucial for NAFLD patients as it addresses key factors contributing to liver disease progression. Additionally, SGLT2 inhibitors improve glycemic control and reduce liver fat by promoting glucose excretion through urine. GLP-1 receptor agonists also enhance insulin sensitivity and decrease liver fat. These treatments are essential as they tackle the metabolic dysfunctions underlying NAFLD.

Find a Location

Who is running the clinical trial?

Inventiva PharmaLead Sponsor
7 Previous Clinical Trials
11,576 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
1,375 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Lanifibranor (PPAR agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05232071 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Matching placebo, Lanifibranor (IVA337) (800 mg/day), Lanifibranor (IVA337) (800 mg/day) plus Empagliflozin (10mg/day)
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Lanifibranor Highlights & Side Effects. Trial Name: NCT05232071 — Phase 2
Lanifibranor (PPAR agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05232071 — Phase 2
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT05232071 — Phase 2
~13 spots leftby Nov 2025