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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 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 128 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03459079
The ClinicalTrials.gov registry entry for NCT03459079 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03459079 reports 0 study locations.
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.
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