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NCT05232071 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Inventiva Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT05232071: Completed Phase 2 study, sponsored by Inventiva Pharma.
NCT05232071 is a Phase 2 study that has completed, run by Inventiva Pharma. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05232071, a Phase 2 study, has completed, sponsored by Inventiva Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study 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.
Primary Outcome
Absolute change in HbA1c from baseline (Week 0) to Week 24
Interventions
- DRUG Placebo
- DRUG Empagliflozin
- DRUG IVA337
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2022-06-29 |
| Est. Completion | 2024-06-04 |
| Phase | Phase 2 |
What the finished NCT05232071 record still lists
NCT05232071 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05232071 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05232071 about?
NCT05232071 is a clinical study titled "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". 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.
What is the current status of trial NCT05232071?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2022-06-29. Estimated completion is 2024-06-04.
What interventions are being tested in trial NCT05232071?
The interventions under investigation include: Placebo (DRUG), Empagliflozin (DRUG), IVA337 (DRUG).
Who is sponsoring clinical trial NCT05232071?
This trial is sponsored by Inventiva Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05232071's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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