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Clinical Trial Details

Trial ID: L6986
Source ID: NCT05232071
Associated Drug: Iva337
Title: 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
Acronym: LEGEND
Status: COMPLETED
Study Results: NO
Results:
Conditions: NASH - Nonalcoholic Steatohepatitis|Diabetes Mellitus, Type 2
Interventions: DRUG: IVA337|DRUG: Placebo|DRUG: Empagliflozin
Outcome Measures: Primary: 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 |
Sponsor/Collaborators: Sponsor: Inventiva Pharma
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 42
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-06-29
Completion Date: 2024-06-04
Results First Posted:
Last Update Posted: 2024-07-09
Locations: Birmingham Digestive Health Research, Homewood, Alabama, 35209, United States|Institute for Liver Health dba Arizona Liver Health, Chandler, Arizona, 85224, United States|ARcare Center for Clinical Research, Conway, Arkansas, 72032, United States|ARcare Center for Clinical Research, Little Rock, Arkansas, 72205, United States|Cure Clinical Research, LLC, Fountain Valley, California, 92708, United States|Velocity Clinical Research, Gardena, California, 90247, United States|National Research Institute, Huntington Park, California, 90255, United States|Cadena Care Institute, LLC, Poway, California, 92064, United States|Florida Research Institute, Lakewood Ranch, Florida, 34211, United States|Galenus Group, Lehigh Acres, Florida, 33936, United States|Prolive Medical Research, Miami, Florida, 33175, United States|Indiana University School of Medicine, Indianapolis, Indiana, 46202, United States|Digestive Health Research of Southern California, South Bend, Indiana, 46635, United States|Tandem Clinical Research - New Orleans Area Site, Marrero, Louisiana, 70072, United States|Harvard Medical School, Boston, Massachusetts, 02115, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|AIG Digestive Disease Research, Florham Park, New Jersey, 07932, United States|Digestive Health Research, Hermitage, Tennessee, 37076, United States|Accelemed Research Institute, Austin, Texas, 78745, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|American Research Corporation, San Antonio, Texas, 78215, United States|Diabetes & Glandular Disease Clinic, P.A., San Antonio, Texas, 78229, United States|Impact Research Institute, Waco, Texas, 76710, United States|Digestive Health Research of North Texas, Wichita Falls, Texas, 76301, United States|University of Virginia, Charlottesville, Virginia, 22908, United States|Central Virginia VA Healthcare System, Richmond, Virginia, 23249, United States|CUB Erasme Hospital, Brussels, 1070, Belgium|Cliniques Universitaires Saint-Luc, Brussels, 1200, Belgium|Universitair Ziekenhuis Antwerpen, Edegem, 2650, Belgium|AZ Maria Middelares, Gent, 9000, Belgium|UZ GENT, Gent, 9000, Belgium|CHU Angers_Service d'hepatogastro-enterologie, Angers, 49000, France|CHU Limoges, Limoges, 87042, France|Hopital Saint Antoine, Paris, 75012, France|CHU Bordeaux, Pessac, 33604, France|Chu Rangueil, Toulouse, 31059, France|HGE CHRU Nancy, Vandoeuvre-lès-Nancy, 54500, France|Amsterdam UMC, Amsterdam, 1105 AZ, Netherlands|Hull University Teaching Hospital, Hull, HU32JZ, United Kingdom|King's College Hospital, London, SE59RS, United Kingdom|St Georges Hospital, London, SW17 0QT, United Kingdom|Royal Victoria Infirmary, Newcastle upon Tyne, NE1 7RU, United Kingdom
URL: https://clinicaltrials.gov/show/NCT05232071

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress