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
Public ClinicalTrials.gov record NCT05232071. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhibitor EmpaGliflozin in patiEnts With Non-alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05232071
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 39 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 29, 2022 (Actual)
- Primary completion
- May 8, 2024 (Actual)
- Completion
- Jun 4, 2024 (Actual)
- Last update posted
- Sep 9, 2026
2022 – 2024
United States locations
- U.S. sites
- 26
- U.S. states
- 13
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Digestive Health Research | Homewood | Alabama | 35209 | — |
| Institute for Liver Health dba Arizona Liver Health | Chandler | Arizona | 85224 | — |
| ARcare Center for Clinical Research | Conway | Arkansas | 72032 | — |
| ARcare Center for Clinical Research | Little Rock | Arkansas | 72205 | — |
| Cure Clinical Research, LLC | Fountain Valley | California | 92708 | — |
| Velocity Clinical Research | Gardena | California | 90247 | — |
| National Research Institute | Huntington Park | California | 90255 | — |
| Cadena Care Institute, LLC | Poway | California | 92064 | — |
| Florida Research Institute | Lakewood Rch | Florida | 34211 | — |
| Galenus Group | Lehigh Acres | Florida | 33936 | — |
| Prolive Medical Research | Miami | Florida | 33175 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| Digestive Health Research of Southern California | South Bend | Indiana | 46635 | — |
| Tandem Clinical Research - New Orleans Area Site | Marrero | Louisiana | 70072 | — |
| Harvard Medical School | Boston | Massachusetts | 02115 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| AIG Digestive Disease Research | Florham Park | New Jersey | 07932 | — |
| Digestive Health Research | Hermitage | Tennessee | 37076 | — |
| Accelemed Research Institute | Austin | Texas | 78745 | — |
| Dallas Diabetes Research Center | Dallas | Texas | 75230 | — |
| American Research Corporation | San Antonio | Texas | 78215 | — |
| Diabetes & Glandular Disease Clinic, P.A. | San Antonio | Texas | 78229 | — |
| Impact Research Institute | Waco | Texas | 76710 | — |
| Digestive Health Research of North Texas | Wichita Falls | Texas | 76301 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Central Virginia VA Healthcare System | Richmond | Virginia | 23249 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05232071, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2026 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05232071 live on ClinicalTrials.gov.