A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhibitor EmpaGliflozin in patiEnts With Non-alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)

Who is this study for? Patients with non-alcoholic steatohepatitis and type 2 diabetes mellitus
Status: Recruiting
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Male or female, aged ≥ 18 years at the time of signing informed consent

• Diagnosis of NASH, based on histology or ct1>875msecs by LiverMuliScan 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.

Locations
United States
Alabama
Birmingham Digestive Health Research
Not yet recruiting
Homewood
Arkansas
ARcare Center for Clinical Research
Not yet recruiting
Conway
Arizona
Institute for Liver Health dba Arizona Liver Health
Active, not recruiting
Chandler
Institute for Liver Health dba Arizona Liver Health
Not yet recruiting
Chandler
California
Velocity Clinical Research
Active, not recruiting
Gardena
National Research Institute
Recruiting
Huntington Park
Cadena Care Institute, LLC
Recruiting
Poway
Florida
Florida Research Institute
Recruiting
Lakewood Ranch
Prolive Medical Research
Recruiting
Miami
Indiana
Indiana University School of Medicine
Not yet recruiting
Indianapolis
Digestive Health Research of Southern California
Not yet recruiting
South Bend
Louisiana
Tandem Clinical Research - New Orleans Area Site
Not yet recruiting
Marrero
Massachusetts
Harvard Medical School
Not yet recruiting
Boston
Minnesota
Mayo Clinic
Not yet recruiting
Rochester
New Jersey
AIG Digestive Disease Research
Not yet recruiting
Florham Park
South Carolina
Digestive Disease Research Center, LLC
Not yet recruiting
Greenwood
Tennessee
Digestive Health Research
Not yet recruiting
Hermitage
Texas
Accelemed Research Institute
Recruiting
Austin
Dallas Diabetes Research Center
Recruiting
Dallas
American Research Corporation
Not yet recruiting
San Antonio
Diabetes & Glandular Disease Clinic, P.A.
Not yet recruiting
San Antonio
Impact Research Institute
Not yet recruiting
Waco
Digestive Health Research of North Texas
Not yet recruiting
Wichita Falls
Virginia
University of Virginia
Not yet recruiting
Charlottesville
Central Virginia VA Healthcare System
Not yet recruiting
Richmond
Other Locations
Belgium
Cliniques Universitaires Saint-Luc
Not yet recruiting
Brussels
CUB Erasme Hospital
Not yet recruiting
Brussels
Universitair Ziekenhuis Antwerpen
Not yet recruiting
Edegem
AZ Maria Middelares
Not yet recruiting
Gent
UZ GENT
Not yet recruiting
Gent
France
CHU Angers_Service d'hepatogastro-enterologie
Not yet recruiting
Angers
CHU Limoges
Not yet recruiting
Limoges
Hopital Saint Antoine
Not yet recruiting
Paris
CHU Bordeaux
Not yet recruiting
Pessac
Chu Rangueil
Not yet recruiting
Toulouse
HGE CHRU Nancy
Not yet recruiting
Vandoeuvre-lès-nancy
Netherlands
Amsterdam UMC
Not yet recruiting
Amsterdam
United Kingdom
Hull University Teaching Hospital
Not yet recruiting
Hull
King's College Hospital
Not yet recruiting
London
St Georges Hospital
Not yet recruiting
London
Royal Victoria Infirmary
Not yet recruiting
Newcastle Upon Tyne
Contact Information
Primary
Pascaline CLERC
clinical.contact@inventivapharma.com
US:2024998937/ROW:+33644637545
Time Frame
Start Date: June 29, 2022
Estimated Completion Date: July 1, 2023
Participants
Target number of participants: 63
Treatments
Experimental: Lanifibranor (IVA337) (800 mg/day)
2 Lanifibranor tablets 400 mg with food --> once a day (quaque die, QD)
Placebo Comparator: Matching placebo
2 Placebo to match tablets with food --> once a day (quaque die, QD)
Experimental: Lanifibranor (IVA337) (800 mg/day) plus Empagliflozin (10mg/day)
2 Lanifibranor tablets 400 mg plus 1 Empagliflozin tablet 10mg with food --> once a day (quaque die, QD)
Sponsors
Leads: Inventiva Pharma

This content was sourced from clinicaltrials.gov

Similar Clinical Trials