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NCT03459079 · ClinicalTrials.gov registry record · Phase 2
Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease
A Phase 2 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
NCT03459079: Completed Phase 2 study, sponsored by University of Florida.
NCT03459079 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 128 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03459079, a Phase 2 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
Study Summary
The primary aim is to establish the safety, efficacy and mechanism of action of lanifibranor in patients with type 2 diabetes (T2DM) and nonalcoholic fatty liver disease (NAFLD). Specifically, to determine if lanifibranor decreases intrahepatic triglycerides (IHTG) (primary endpoint), improves hepatic insulin sensitivity, endogenous (hepatic) glucose production, de novo lipogenesis (DNL), HbA1c and lipid profiles. In addition, exploratory analysis with surrogate plasma biomarkers and imaging on liver fibrosis changes on with treatment will be performed.
Primary Outcome
Changes from baseline (Adjusted LS means) in absolute percent for change in intrahepatic triglycerides (IHTG) quantified by proton magnetic resonance and spectroscopy (¹H-MRS)are reported in each arms.
Interventions
- OTHER Placebo
- DRUG Lanifibranor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2018-08-14 |
| Est. Completion | 2023-06-01 |
| Phase | Phase 2 |
What the finished NCT03459079 record still lists
NCT03459079 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03459079 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03459079 about?
NCT03459079 is a clinical study titled "Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease". The primary aim is to establish the safety, efficacy and mechanism of action of lanifibranor in patients with type 2 diabetes (T2DM) and nonalcoholic fatty liver disease (NAFLD). Specifically, to determine if lanifibranor decreases intrahepatic triglycerides (IHTG) (primary endpoint), improves hepat...
What is the current status of trial NCT03459079?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2018-08-14. Estimated completion is 2023-06-01.
What interventions are being tested in trial NCT03459079?
The interventions under investigation include: Placebo (OTHER), Lanifibranor (DRUG).
Who is sponsoring clinical trial NCT03459079?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03459079's enrollment target sits among peer trials
128 553rd of 2000 higher than 1,446 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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