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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 (LEGEND)

Primary Purpose

NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IVA337
Placebo
Empagliflozin
Sponsored by
Inventiva Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female, aged ≥ 18 years at the time of signing informed consent
  2. Diagnosis of NASH, based on histology or ct1>875msecs by LiverMuliScan at screening
  3. 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
  4. Negative pregnancy test at Screening for females of childbearing potential or at least two-year post-menopausal.

Exclusion Criteria:

Liver-related:

  1. Documented causes of chronic liver disease other than NASH
  2. Histologically documented liver cirrhosis (fibrosis stage F4)
  3. History or current diagnosis of hepatocellular carcinoma (HCC)
  4. History of or planned liver transplant
  5. Documented history of human immunodeficiency virus (HIV) infection
  6. ALT or AST > 5 × upper limit of normal (ULN)
  7. Abnormal liver function as defined by central laboratory evaluation:

    Albumin < LLN INR ≥ 1.3 (unless patient is on anticoagulants)

    Total bilirubin level ≥ 1.3 mg/dL (22.2 µmol/L) (patients with a documented history of Gilbert's syndrome can be enrolled if direct bilirubin is within normal reference range)

  8. Hemoglobin < 110 g/L (11 g/dL) for females and < 120 g/L (12 g/dL) for males
  9. WBC < LLN
  10. Platelet count < 150,000/µL
  11. ALP > 2 × ULN
  12. Patient currently receiving any approved treatment for NASH or obesity
  13. Current or recent history (< 5 years) of significant alcohol consumption
  14. Administration of drugs known to produce hepatic steatosis in the 6 months prior to Screening.

    Diabetes related:

  15. Diabetes mellitus other than type 2
  16. Diabetic ketoacidosis at Screening
  17. Current treatment with glucagon-like peptide-1 receptor agonists (GLP-1RA), insulin or sulfonylurea or treatment within the last 3 months prior to Screening
  18. Patients on pioglitazone in the last 12 months prior to Screening. Patients on metformin, DPP-IVi, thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels, unless on stable doses in last 3 months

    Obesity related:

  19. BMI>45 kg/m2 at screening
  20. Introduction of an anti-obesity drug or restrictive bariatric surgery in the past 12 months prior to Screening or planned bariatric surgery through Week 24.

    Cardiovascular related:

  21. History of or current unstable cardiac dysrhythmias
  22. Unstable heart failure
  23. Uncontrolled hypertension
  24. Stroke or transient ischemic attack

    General safety:

  25. Significant systemic or major illnesses other than liver disease and pulmonary disease, organ transplantation, serious psychiatric disease, that, in the opinion of the investigator, would preclude treatment with lanifibranor and/or adequate follow up
  26. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value < 60 mL/min
  27. Concomitant treatment with PPAR-⍺ agonists (fibrates)
  28. Have a known hypersensitivity to any of the IMPs
  29. Previous exposure to lanifibranor or empagliflozin
  30. Present pregnancy/lactation
  31. Metallic implant of any sort that prevents MRI examination
  32. Participation in any clinical trial of an approved or non approved investigational medicinal product/device within 3 months from Screening or five half-lives of the investigational drug from Screening.

Sites / Locations

  • Birmingham Digestive Health ResearchRecruiting
  • Institute for Liver Health dba Arizona Liver HealthRecruiting
  • Institute for Liver Health dba Arizona Liver HealthRecruiting
  • ARcare Center for Clinical ResearchRecruiting
  • ARcare Center for Clinical ResearchRecruiting
  • Cure Clinical Research, LLCRecruiting
  • Velocity Clinical ResearchRecruiting
  • National Research InstituteRecruiting
  • Cadena Care Institute, LLCRecruiting
  • Florida Research InstituteRecruiting
  • Galenus GroupRecruiting
  • Prolive Medical ResearchRecruiting
  • Indiana University School of MedicineRecruiting
  • Digestive Health Research of Southern CaliforniaRecruiting
  • Tandem Clinical Research - New Orleans Area SiteRecruiting
  • Harvard Medical SchoolRecruiting
  • Mayo ClinicRecruiting
  • AIG Digestive Disease ResearchRecruiting
  • Digestive Disease Research Center, LLCRecruiting
  • Digestive Health ResearchRecruiting
  • Accelemed Research InstituteRecruiting
  • Dallas Diabetes Research CenterRecruiting
  • American Research CorporationRecruiting
  • Diabetes & Glandular Disease Clinic, P.A.Recruiting
  • Impact Research InstituteRecruiting
  • Digestive Health Research of North TexasRecruiting
  • University of VirginiaRecruiting
  • Central Virginia VA Healthcare SystemRecruiting
  • CUB Erasme HospitalRecruiting
  • Cliniques Universitaires Saint-LucRecruiting
  • Universitair Ziekenhuis AntwerpenRecruiting
  • AZ Maria MiddelaresRecruiting
  • UZ GENTRecruiting
  • CHU Angers_Service d'hepatogastro-enterologieRecruiting
  • CHU LimogesRecruiting
  • Hopital Saint AntoineRecruiting
  • CHU BordeauxRecruiting
  • Chu RangueilRecruiting
  • HGE CHRU NancyRecruiting
  • Amsterdam UMCRecruiting
  • Hull University Teaching Hospital
  • King's College HospitalRecruiting
  • St Georges Hospital
  • Royal Victoria InfirmaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Lanifibranor (IVA337) (800 mg/day)

Matching placebo

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 26, 2022
Last Updated
September 1, 2023
Sponsor
Inventiva Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05232071
Brief 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
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inventiva Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lanifibranor (IVA337) (800 mg/day)
Arm Type
Experimental
Arm Description
2 Lanifibranor tablets 400 mg with food --> once a day (quaque die, QD)
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Arm Description
2 Placebo to match tablets with food --> once a day (quaque die, QD)
Arm Title
Lanifibranor (IVA337) (800 mg/day) plus Empagliflozin (10mg/day)
Arm Type
Experimental
Arm Description
2 Lanifibranor tablets 400 mg plus 1 Empagliflozin tablet 10mg with food --> once a day (quaque die, QD)
Intervention Type
Drug
Intervention Name(s)
IVA337
Other Intervention Name(s)
Lanifibranor
Intervention Description
800 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Other Intervention Name(s)
Jardiance
Intervention Description
10 mg
Primary Outcome Measure Information:
Title
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
Description
Absolute change in HbA1c from baseline (Week 0) to Week 24
Time Frame
Date of randomisation until the end of treatment at week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Administration of drugs known to produce hepatic steatosis in the 6 months prior to Screening. Diabetes related: Diabetes mellitus other than type 2 Diabetic ketoacidosis at Screening Current treatment with glucagon-like peptide-1 receptor agonists (GLP-1RA), insulin or sulfonylurea or treatment within the last 3 months prior to Screening Patients on pioglitazone in the last 12 months prior to Screening. Patients on metformin, DPP-IVi, thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels, unless on stable doses in last 3 months Obesity related: BMI>45 kg/m2 at screening Introduction of an anti-obesity drug or restrictive bariatric surgery in the past 12 months prior to Screening or planned bariatric surgery through Week 24. Cardiovascular related: 21. History of or current unstable cardiac dysrhythmias 22. Unstable heart failure 23. Uncontrolled hypertension 24. Stroke or transient ischemic attack General safety: 25. Significant systemic or major illnesses other than liver disease and pulmonary disease, organ transplantation, serious psychiatric disease, that, in the opinion of the investigator, would preclude treatment with lanifibranor and/or adequate follow up 26. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value < 60 mL/min 27. Concomitant treatment with PPAR-⍺ agonists (fibrates) 28. Patients on Vitamin E at doses ≥ 400 IU/day; doses of ≥ 400 IU/day are allowed when no qualitative change in dose for 6 months prior to Screening 29. Have a known hypersensitivity to any of the IMPs 30. Previous exposure to lanifibranor or empagliflozin 31. Present pregnancy/lactation 32. Metallic implant of any sort that prevents MRI examination 33. Participation in any clinical trial of an approved or non approved investigational medicinal product/device within 3 months from Screening or five half-lives of the investigational drug from Screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pascaline CLERC
Phone
US:2024998937/ROW:+33644637545
Email
clinical.contact@inventivapharma.com
Facility Information:
Facility Name
Birmingham Digestive Health Research
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Dasher
Facility Name
Institute for Liver Health dba Arizona Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naim Alkhouri
Facility Name
Institute for Liver Health dba Arizona Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Kohli
Facility Name
ARcare Center for Clinical Research
City
Conway
State/Province
Arkansas
ZIP/Postal Code
72032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Landon Humphrey
Facility Name
ARcare Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Senthil Raghavan
Facility Name
Cure Clinical Research, LLC
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramprasad Dandillaya
Facility Name
Velocity Clinical Research
City
Gardena
State/Province
California
ZIP/Postal Code
90247
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Leibowitz
Facility Name
National Research Institute
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanley Hsia
Facility Name
Cadena Care Institute, LLC
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Merkes
Facility Name
Florida Research Institute
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Souvik Sarkar
Facility Name
Galenus Group
City
Lehigh Acres
State/Province
Florida
ZIP/Postal Code
33936
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edgardo Castillo-Nieves
Facility Name
Prolive Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Suarez
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Orman
Facility Name
Digestive Health Research of Southern California
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46635
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saedi Goshtasbi
Facility Name
Tandem Clinical Research - New Orleans Area Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Reiss
Facility Name
Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle LAI
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manal Abdelmalek
Facility Name
AIG Digestive Disease Research
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Wallach
Facility Name
Digestive Disease Research Center, LLC
City
Greenwood
State/Province
South Carolina
ZIP/Postal Code
29646
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Bachinski
Facility Name
Digestive Health Research
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald Lazas
Facility Name
Accelemed Research Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nomita Kim
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio Rosenstock
Facility Name
American Research Corporation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Lawitz
Facility Name
Diabetes & Glandular Disease Clinic, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Kipnes
Facility Name
Impact Research Institute
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadege Gunn
Facility Name
Digestive Health Research of North Texas
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis Wilson
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ananda Basu
Facility Name
Central Virginia VA Healthcare System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Puri Puneet
Facility Name
CUB Erasme Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Moreno
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Lanthier
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Francque
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Van Steenkiste
Facility Name
UZ GENT
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anja Geerts
Facility Name
CHU Angers_Service d'hepatogastro-enterologie
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerome Boursier
Facility Name
CHU Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique Loustaud Ratti
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Lequoy
Facility Name
CHU Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor De Ledinghen
Facility Name
Chu Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Metivier
Facility Name
HGE CHRU Nancy
City
Vandoeuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Bronowicki
Facility Name
Amsterdam UMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriaan Holleboom
Facility Name
Hull University Teaching Hospital
City
Hull
ZIP/Postal Code
HU32JZ
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE59RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaushik Agarwal
Facility Name
St Georges Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 7RU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quentin Anstee

12. IPD Sharing Statement

Learn more about this trial

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

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