Lanifibranor,
does it really help with Histologic activity improvement in noncirrhotic active MASH?
research showsThe grade is C. In the 247-person phase 2b NATIVE trial, a ≥2-point SAF-A decrease without fibrosis worsening occurred in 55% with 1,200 mg versus 33% with placebo, difference 22 points (P=.007). The 800-mg result was 48% versus 33%, difference 15 points (P=.07).
ads claimHistologic improvement must not be expanded into proven prevention of cirrhosis, transplantation, or death.
Useful facts when choosing a product
- Mean weight gain was about 2.7 kg with 1,200 mg and 2.4 kg with 800 mg.
- Peripheral edema was more frequent; two drug-related cases occurred at each dose.
What the research actually shows
NATIVE randomized 247 patients with noncirrhotic active MASH to 1,200 mg, 800 mg, or placebo for 24 weeks and was funded by Inventiva. Axis 6 B0 evidence ① Allocation concealment: "randomly assigned in a 1:1:1 ratio" with a central interactive response system ② Blinding: "double-blind" with central pathology reading ③ Analysis population and missingness: randomized treated participants were analyzed and missing biopsies were counted as nonresponse ④ Prespecified primary endpoint: "The primary end point was a decrease of at least 2 points ... in the SAF-A score and no worsening of fibrosis" - consistent with NCT03008070 Verdict 607 is C with 59 points for pioglitazone, an insulin sensitizer; verdict 894 is C with 58 points for resmetirom, a thyroid-hormone-receptor-beta agonist; verdict 1146 is C with 58 points for semaglutide, a GLP-1 agonist; verdict 493 is C with 59 points for vitamin E, an antioxidant supplement. They address the same disease with different agents and stages of evidence.
Why this is classified as C (54)
One manufacturer-funded phase 2 histologic-surrogate trial gives C with 54 points.
Counterpoint. Clinical-event prevention remains unanswered.
Rejudgment record. New verdict — Positive histologic surrogate in one manufacturer-funded phase 2b trial without clinical events
| Endpoint | S | Surrogate marker - laboratory or imaging measures |
| Replication | R1 | Single confirmatory trial |
| Independence | I0 | Evidence comes only from manufacturer studies |
| Effect size | E+ | Meets the clinically important threshold |
The scoring table and the verdict agree (C).
Sub-claim grades by effect
This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.
| Effect (sub-claim) | Grade | Basis |
|---|---|---|
| SAF-A histologic response | C | The 1,200-mg dose was positive; 800 mg was not significant. |
| Reduced cirrhosis, transplantation, or death | ? | The trial did not evaluate these clinical events. |
Cross-check — AI research and Codex final gate
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Study 1 | Phase 2b double-blind randomized placebo-controlled trial | 247 | Funded by Inventiva Pharma | ≥2-point SAF-A decrease without fibrosis worsening at week 24 | 1,200 mg 55% versus placebo 33%, +22 points (P=.007); 800 mg 48%, +15 points (P=.07). | Pivotal histologic-surrogate evidence |
Receipt — 1 References
All 1 cited sources were verified for existence at the original page (as of 2026-08-26).
Final verification and publication gate: Codex · Verification cutoff: 2026-08-26 · Corrections: none
Cite this verdict
[Chamgap] Benefit of Lanifibranor for Histologic Activity Improvement in Noncirrhotic Active MASH, a Surrogate Outcome — Evidence Grade C·54. 1 cited sources checked. Source: https://chamgap.com/en/verdicts/liver/lanifibranor-active-mash-histologic-activity/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
What this document does and does not do
Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.