ClinicalTrials.gov posted results on 9 September 2026 for a completed Phase 2 study evaluating empagliflozin with lanifibranor in people with NASH and type 2 diabetes. The least-squares mean change in HbA1c was −1.54 percentage points with the combination, compared with 0.16 percentage points with placebo.

Background

The study evaluated lanifibranor alone and in combination with empagliflozin, an SGLT2 inhibitor, in patients with nonalcoholic steatohepatitis and type 2 diabetes. Its stated purpose was to assess lanifibranor’s effect versus placebo on glycemic control and evaluate the combination’s effect on glycemic control.

Trial design

This completed Phase 2 study, identified as NCT05232071, enrolled 39 participants. The listed interventions were lanifibranor, empagliflozin, and placebo. Reported groups included lanifibranor at 800 mg/day, lanifibranor at 800 mg/day plus empagliflozin at 10 mg/day, and placebo. The record supplied no primary-outcome entries.

Key results

For absolute change in HbA1c, the least-squares means were −1.11 percentage points with lanifibranor alone, −1.54 percentage points with the combination, and 0.16 percentage points with placebo.

For liver tests, ALT changed by −26.60 U/L with lanifibranor, −29.63 U/L with the combination, and −5.65 U/L with placebo. AST changed by −13.67 U/L, −17.81 U/L, and 1.3 U/L, respectively.

HOMA-IR changed by −50.79% with lanifibranor, −45.23% with the combination, and 35.01% with placebo. Mixed-model analyses reported LS mean differences versus placebo of −1.27 (95% CI, −1.95 to −0.58; p=0.001) and −1.7 (95% CI, −2.38 to −1.02; p=0.001).

What this means

The posted measurements showed larger HbA1c reductions with lanifibranor alone and with the lanifibranor–empagliflozin combination than with placebo. The supplied record did not include an adverse-event summary, so it does not establish comparative safety.

Source

Source: ClinicalTrials.gov, registry results for the completed proof-of-concept study of lanifibranor alone and with empagliflozin in NASH and type 2 diabetes, posted 9 September 2026. Available at clinicaltrials.gov/study/NCT05232071.