Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus

NCT05232071 | Completed Phase 2 FDA Drug

• 1 other identifier: 337HNAS21016
• Study Type: interventional
• Target: 42
• Locations: 5 countries
• Sites: 42

Brief Summary

The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.

Conditions

NASH - Nonalcoholic Steatohepatitis; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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

  Absolute change in HbA1c from baseline (Week 0) to Week 24

  Date of randomisation until the end of treatment at week 24

Study Arms (3)

Lanifibranor (IVA337) (800 mg/day)

EXPERIMENTAL

2 Lanifibranor tablets 400 mg with food --\> once a day (quaque die, QD)

Drug: IVA337

Matching placebo

PLACEBO COMPARATOR

2 Placebo to match tablets with food --\> once a day (quaque die, QD)

Drug: Placebo

Lanifibranor (IVA337) (800 mg/day) plus Empagliflozin (10mg/day)

EXPERIMENTAL

2 Lanifibranor tablets 400 mg plus 1 Empagliflozin tablet 10mg with food --\> once a day (quaque die, QD)

Drug: IVA337; Drug: Empagliflozin

Interventions

IVA337 DRUG

800 mg

Also known as: Lanifibranor

Lanifibranor (IVA337) (800 mg/day); Lanifibranor (IVA337) (800 mg/day) plus Empagliflozin (10mg/day)

Placebo DRUG

Placebo to match

Matching placebo

Empagliflozin DRUG

10 mg

Also known as: Jardiance

Lanifibranor (IVA337) (800 mg/day) plus Empagliflozin (10mg/day)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥ 18 years at the time of signing informed consent
• Diagnosis of NASH, based on histology or cT1≥875ms assessed by LiverMultiScan or cT1≥825ms assessed by LiverMultiScan and hepatic fat content ≥ 10% assessed by MRI-PDFF at screening
• HbA1c at screening ≥ 7.0 and ≤ 10.0%, on diet alone, or on metformin and/or dipeptidyl peptidase 4 inhibitor (DPP-IVi) therapy. Both with doses to be stable for 3 months
• Negative pregnancy test at Screening for females of childbearing potential or at least two-year post-menopausal.

You may not qualify if:

• Liver-related:
• Documented causes of chronic liver disease other than NASH
• Histologically documented liver cirrhosis (fibrosis stage F4)
• History or current diagnosis of hepatocellular carcinoma (HCC)
• History of or planned liver transplant
• Documented history of human immunodeficiency virus (HIV) infection
• ALT or AST \> 5 × upper limit of normal (ULN)
• Abnormal liver function as defined by central laboratory evaluation:
• Albumin \< LLN INR ≥ 1.3 (unless patient is on anticoagulants) Total bilirubin level ≥ 1.5 mg/dL (25.7 µmol/L) (patients with a documented history of Gilbert's syndrome can be enrolled if direct bilirubin is ≤ 0.45 mg/dL (7.7 μmol/L) )
• Hemoglobin \< 110 g/L (11 g/dL) for females and \< 120 g/L (12 g/dL) for males
• WBC \< LLN. A lower count is acceptable in patients with benign ethnic neutropenia, if considered to be clinical insignificant by the investigator
• Platelet count \< 140,000/µL
• ALP \> 2 × ULN
• Patient currently receiving any approved treatment for NASH or obesity
• Current or recent history (\< 5 years) of significant alcohol consumption

Sponsors & Collaborators

• Inventiva Pharma: lead

Study Sites (42)

Birmingham Digestive Health Research

Homewood, Alabama, 35209, United States

Location

Institute for Liver Health dba Arizona Liver Health

Chandler, Arizona, 85224, United States

Location

ARcare Center for Clinical Research

Conway, Arkansas, 72032, United States

Location

ARcare Center for Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Cure Clinical Research, LLC

Fountain Valley, California, 92708, United States

Location

Velocity Clinical Research

Gardena, California, 90247, United States

Location

National Research Institute

Huntington Park, California, 90255, United States

Location

Cadena Care Institute, LLC

Poway, California, 92064, United States

Location

Florida Research Institute

Lakewood Rch, Florida, 34211, United States

Location

Galenus Group

Lehigh Acres, Florida, 33936, United States

Location

Prolive Medical Research

Miami, Florida, 33175, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Digestive Health Research of Southern California

South Bend, Indiana, 46635, United States

Location

Tandem Clinical Research - New Orleans Area Site

Marrero, Louisiana, 70072, United States

Location

Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

AIG Digestive Disease Research

Florham Park, New Jersey, 07932, United States

Location

Digestive Health Research

Hermitage, Tennessee, 37076, United States

Location

Accelemed Research Institute

Austin, Texas, 78745, United States

Location

Dallas Diabetes Research Center

Dallas, Texas, 75230, United States

Location

American Research Corporation

San Antonio, Texas, 78215, United States

Location

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, 78229, United States

Location

Impact Research Institute

Waco, Texas, 76710, United States

Location

Digestive Health Research of North Texas

Wichita Falls, Texas, 76301, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Central Virginia VA Healthcare System

Richmond, Virginia, 23249, United States

Location

CUB Erasme Hospital

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

UZ GENT

Ghent, 9000, Belgium

Location

CHU Angers_Service d'hepatogastro-enterologie

Angers, 49000, France

Location

CHU Limoges

Limoges, 87042, France

Location

Hopital Saint Antoine

Paris, 75012, France

Location

CHU Bordeaux

Pessac, 33604, France

Location

Chu Rangueil

Toulouse, 31059, France

Location

HGE CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

Location

Hull University Teaching Hospital

Hull, HU32JZ, United Kingdom

Location

King's College Hospital

London, SE59RS, United Kingdom

Location

St Georges Hospital

London, SW17 0QT, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 7RU, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2

Interventions

lanifibranor; empagliflozin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 9, 2022
• Study Start: June 29, 2022
• Primary Completion: March 30, 2024
• Study Completion: June 4, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

US (26); FR (6); BE (5); GB (4); NL (1)