| Trial ID: | L0345 |
| Source ID: | NCT05232071
|
| Associated Drug: |
Empagliflozin
|
| 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: |
Not yet recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NASH - Nonalcoholic Steatohepatitis|Diabetes Mellitus, Type 2
|
| Interventions: |
Drug: IVA337|Drug: Placebo|Drug: Empagliflozin
|
| 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
|
| Sponsor/Collaborators: |
Inventiva Pharma
|
| Gender: |
All
|
| Age: |
18 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
63
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
June 1, 2022
|
| Completion Date: |
July 1, 2023
|
| Results First Posted: |
--
|
| Last Update Posted: |
March 2, 2022
|
| Locations: |
--
|
| URL: |
https://ClinicalTrials.gov/show/NCT05232071
|
