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

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

June 29, 2022

Primary Completion Date

March 30, 2024

Study Completion Date

June 4, 2024

Conditions
NASH - Nonalcoholic SteatohepatitisDiabetes Mellitus, Type 2
Interventions
DRUG

IVA337

800 mg

DRUG

Placebo

Placebo to match

DRUG

Empagliflozin

10 mg

Trial Locations (42)

1070

CUB Erasme Hospital, Brussels

1200

Cliniques Universitaires Saint-Luc, Brussels

2650

Universitair Ziekenhuis Antwerpen, Edegem

9000

AZ Maria Middelares, Ghent

UZ GENT, Ghent

22908

University of Virginia, Charlottesville

23249

Central Virginia VA Healthcare System, Richmond

31059

Chu Rangueil, Toulouse

33175

Prolive Medical Research, Miami

33604

CHU Bordeaux, Pessac

33936

Galenus Group, Lehigh Acres

34211

Florida Research Institute, Lakewood Rch

35209

Birmingham Digestive Health Research, Homewood

37076

Digestive Health Research, Hermitage

46202

Indiana University School of Medicine, Indianapolis

46635

Digestive Health Research of Southern California, South Bend

49000

CHU Angers_Service d'hepatogastro-enterologie, Angers

54500

HGE CHRU Nancy, Vandœuvre-lès-Nancy

55905

Mayo Clinic, Rochester

70072

Tandem Clinical Research - New Orleans Area Site, Marrero

72032

ARcare Center for Clinical Research, Conway

72205

ARcare Center for Clinical Research, Little Rock

75012

Hopital Saint Antoine, Paris

75230

Dallas Diabetes Research Center, Dallas

76301

Digestive Health Research of North Texas, Wichita Falls

76710

Impact Research Institute, Waco

78215

American Research Corporation, San Antonio

78229

Diabetes & Glandular Disease Clinic, P.A., San Antonio

78745

Accelemed Research Institute, Austin

85224

Institute for Liver Health dba Arizona Liver Health, Chandler

87042

CHU Limoges, Limoges

90247

Velocity Clinical Research, Gardena

90255

National Research Institute, Huntington Park

92064

Cadena Care Institute, LLC, Poway

92708

Cure Clinical Research, LLC, Fountain Valley

02115

Harvard Medical School, Boston

07932

AIG Digestive Disease Research, Florham Park

1105 AZ

Amsterdam UMC, Amsterdam

HU32JZ

Hull University Teaching Hospital, Hull

SE59RS

King's College Hospital, London

SW17 0QT

St Georges Hospital, London

NE1 7RU

Royal Victoria Infirmary, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Inventiva Pharma

INDUSTRY

NCT05232071 - 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 | Biotech Hunter | Biotech Hunter