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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ date of randomisation until the end of treatment at week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of randomisation until the end of treatment at week 24
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 • NCT0305795115%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or I have been menopausal for at least two years.I've been on stable doses of certain medications that can affect blood sugar for the last 3 months.I have previously taken lanifibranor or empagliflozin.My blood tests show low albumin, high INR, and high bilirubin levels.Your blood platelet count is less than 140,000 per microliter.I haven't started any new obesity drugs or had/planned weight loss surgery in the last year.My HbA1c is between 7.0% and 10.0%, and I'm on a stable dose of diet, metformin, or DPP-IVi for 3 months.I haven't been in a drug study within the last 3 months or five half-lives of the drug.I have had a stroke or a mini-stroke.Your ALP levels are more than twice the normal range.I have diabetes, but it's not type 2.My high blood pressure is not under control.You have a very high body mass index (BMI) at screening.I have a history of or currently have irregular heartbeats.My heart failure is not stable.I have been taking Vitamin E at doses of 400 IU/day or more without changing the dose for the last 6 months.You have been drinking a lot of alcohol within the past 5 years.I have had or am planning to have a liver transplant.Your ALT or AST levels are more than 5 times the normal limit.You have a metal implant that would stop you from having an MRI scan.My kidney function is reduced with an eGFR below 60 mL/min.I have or had liver cancer.I am 18 years old or older.I have been diagnosed with NASH through a liver scan or MRI showing high fat content.I am currently using or have used GLP-1RA, insulin, or sulfonylurea in the last 3 months.I don't have major illnesses that would interfere with the treatment.I have been diagnosed with advanced liver scarring.I have been diagnosed with HIV.My hemoglobin level is below the normal range for my gender.I am currently taking medication for cholesterol that activates PPAR-alpha.I am currently on approved treatments for NASH or obesity.Your white blood cell count is lower than the normal range, but it might be okay if it's due to a condition called benign ethnic neutropenia and your doctor thinks it's not a problem for your health.You have had a serious condition called diabetic ketoacidosis when you were screened for the trial.You have a type of liver disease that is not caused by NASH.I have taken pioglitazone in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Matching placebo
- Group 2: Lanifibranor (IVA337) (800 mg/day)
- Group 3: Lanifibranor (IVA337) (800 mg/day) plus Empagliflozin (10mg/day)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT05232071 — Phase 2
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