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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
Awards & highlights
LEGEND Trial Summary
This trial will test the effect of the drug lanifibranor on diabetes control in patients also taking an SGLT2 inhibitor.
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.Check my eligibility
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.See study design
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.
LEGEND Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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%
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%
Myocardial infarction
1%
Cardiac failure chronic
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
LEGEND 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
~400
Empagliflozin
2017
Completed Phase 4
~181750
Find a Location
Who is running the clinical trial?
Inventiva PharmaLead Sponsor
6 Previous Clinical Trials
1,576 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Birmingham Digestive Health Research
Cure Clinical Research, LLC
What questions have other patients asked about this trial?
Why did patients apply to this trial?
I've tried Metformin which didn't work, I hope this trial will help me find something that works.
PatientReceived 2+ prior treatments
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