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

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Inventiva Pharma
Study ID
NCT05232071
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IVA337 — DRUG
    800 mg
  • Placebo — DRUG
    Placebo to match
  • Empagliflozin — DRUG
    10 mg

Study Details

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.

Key Dates

Start date
Jun 29, 2022
Status verified
Jul 2024
Primary completion
Mar 30, 2024
Completion
Jun 4, 2024

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

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 [ Time Frame: Date of randomisation until the end of treatment at week 24 ]

Locations (26)

FacilityCityStateZIPSite coordinators
Birmingham Digestive Health ResearchHomewoodAlabama35209-
Institute for Liver Health dba Arizona Liver HealthChandlerArizona85224-
ARcare Center for Clinical ResearchConwayArkansas72032-
ARcare Center for Clinical ResearchLittle RockArkansas72205-
Cure Clinical Research, LLCFountain ValleyCalifornia92708-
Velocity Clinical ResearchGardenaCalifornia90247-
National Research InstituteHuntington ParkCalifornia90255-
Cadena Care Institute, LLCPowayCalifornia92064-
Florida Research InstituteLakewood RchFlorida34211-
Galenus GroupLehigh AcresFlorida33936-
Prolive Medical ResearchMiamiFlorida33175-
Indiana University School of MedicineIndianapolisIndiana46202-
Digestive Health Research of Southern CaliforniaSouth BendIndiana46635-
Tandem Clinical Research - New Orleans Area SiteMarreroLouisiana70072-
Harvard Medical SchoolBostonMassachusetts02115-
Mayo ClinicRochesterMinnesota55905-
AIG Digestive Disease ResearchFlorham ParkNew Jersey07932-
Digestive Health ResearchHermitageTennessee37076-
Accelemed Research InstituteAustinTexas78745-
Dallas Diabetes Research CenterDallasTexas75230-
American Research CorporationSan AntonioTexas78215-
Diabetes & Glandular Disease Clinic, P.A.San AntonioTexas78229-
Impact Research InstituteWacoTexas76710-
Digestive Health Research of North TexasWichita FallsTexas76301-
University of VirginiaCharlottesvilleVirginia22908-
Central Virginia VA Healthcare SystemRichmondVirginia23249-

Find similar trials in Homewood, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Birmingham Digestive Health Research· Homewood, ALInstitute for Liver Health dba Arizona Liver Health· Chandler, AZARcare Center for Clinical Research· Conway, ARARcare Center for Clinical Research· Little Rock, ARCure Clinical Research, LLC· Fountain Valley, CAVelocity Clinical Research· Gardena, CA

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