NCT05232071: LEGEND

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

Completed Phase 2 Last updated 9 July 2024

What this trial tests

Phase 2 trial testing IVA337 in NASH - Nonalcoholic Steatohepatitis in 42 participants. Completed in 4 June 2024.

Timeline

29 June 2022

Primary endpoint
30 March 2024

4 June 2024

Quick facts

Lead sponsor	Inventiva Pharma
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	42
Start date	29 June 2022
Primary completion	30 March 2024
Estimated completion	4 June 2024
Sites	42 locations across France, Netherlands, Belgium, United Kingdom, United States

Drugs / interventions tested

• IVA337 — full drug profile →
• Placebo
• Empagliflozin (empagliflozin) — full drug profile →

Conditions studied

• NASH - Nonalcoholic Steatohepatitis — all drugs for NASH - Nonalcoholic Steatohepatitis →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Inventiva Pharma — full company profile →

Who can join

18 and older, any sex, with NASH - Nonalcoholic Steatohepatitis or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Clinical Trial Status and Future Prospects of PPAR-Targeted Drugs for Treating Nonalcoholic Fatty Liver Disease.
   Kamata S, Honda A, Ishii I. · · 2023 · cited 42× · PMID 37627329 · DOI 10.3390/biom13081264
2. MetALD: Does it require a different therapeutic option?
   Marek GW, Malhi H. · · 2024 · cited 21× · PMID 38820071 · DOI 10.1097/hep.0000000000000935
3. Current Therapeutical Approaches Targeting Lipid Metabolism in NAFLD.
   Vitulo M, Gnodi E, Rosini G, Meneveri R, et al · · 2023 · cited 21× · PMID 37628929 · DOI 10.3390/ijms241612748
4. Potential therapeutic strategies for MASH: from preclinical to clinical development.
   Xie Z, Li Y, Cheng L, Huang Y, et al · · 2024 · cited 11× · PMID 39872142 · DOI 10.1093/lifemeta/loae029
5. Emerging pharmacological treatment options for MAFLD.
   Rojas Á, Lara-Romero C, Muñoz-Hernández R, Gato S, et al · · 2022 · cited 11× · PMID 36533188 · DOI 10.1177/20420188221142452
6. Pharmaceutical Strategies to Improve Druggability of Potential Drug Candidates in Nonalcoholic Fatty Liver Disease Therapy.
   Amatya R, Lee D, Min KA, Shin MC. · · 2023 · cited 9× · PMID 37514148 · DOI 10.3390/pharmaceutics15071963
7. Peroxisome proliferator-activated receptor delta and liver diseases.
   Yamazaki T, Cable EE, Cable EE, Schnabl B, et al · · 2025 · cited 8× · PMID 39899669 · DOI 10.1097/hc9.0000000000000646
8. Application of PPAR Ligands and Nanoparticle Technology in Metabolic Steatohepatitis Treatment.
   Vu HT, Nguyen VD, Ikenaga H, Matsubara T. · · 2024 · cited 5× · PMID 39200340 · DOI 10.3390/biomedicines12081876