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Active Comparator:4.5mg GRI-0621 · GRI-201

Trial to Examine the Effect of Two Doses of GRI-0621 in Patients With Chronic Liver Disease

Ensayo de GRI Bio, Inc. en Chronic Liver Disease (del registro, en inglés).

Lo que ha anunciado la empresa

La empresa anunció que alcanzó su objetivo principal…collagen turnover, lung tissue repair, and improvements in pulmonary function, further strengthening the overall clinical proof-of-concept for GRI-0621.” The Company previously reported that the study met its primary endpoint, demonstrating a safety and tolerability profile differentiated from that of existing treatment options. The study also met secondary endpoints suggestive of disease-modifying activity, reversal of fibrosis…

En un 8-K del 8 ene 2026, en una frase que nombra «GRI-0621». El documento en la SEC.

La empresa anunció que alcanzó su objetivo principalEX-99.1 2 ex991_pressreleasetoplined.htm EX-99.1 Exhibit 99.1 GRI Bio Announces Positive Topline Data from its Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”) Study met its primary endpoint demonstrating that GRI-0621 was well tolerated over 12 weeks of treatment, with no drug-related severe or serious adverse events and no increase in GI issues when used with existing approved treatments…

En un 8-K del 10 dic 2025, en una frase que nombra «GRI-0621». El documento en la SEC.

La empresa anunció que alcanzó su objetivo principal…) has received topline data from the Phase 2a GRI-0621-IPF-02 clinical trial evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”). This topline data indicates that the trial met its primary endpoint and certain secondary endpoints that have been evaluated to date demonstrating that GRI-0621 was well tolerated over a 12-week treatment period, consistent with earlier studies evaluating over 1,700 subjects…

En un 8-K del 8 dic 2025, en una frase que nombra «GRI-0621». El documento en la SEC.

Fase

Fase 2

Estado

Interrumpido

Participantes

14

previstos

Centros

1

Fin del objetivo primario

nov 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en sep 2015.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Administrative decision».

Qué mide

Change in serum ALT levels from Day 0 (baseline) to Day 28 (0 and 28 days) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary objectives: To evaluate the change in serum alanine transaminase \[ALT\] levels from Day 0 to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 compared to placebo, in patients with chronic liver disease and elevated serum levels of ALT. Serum ALT level will be used as a marker of liver inflammation. To assess the safety and tolerability of GRI-0621 at these two doses. Secondary objectives: To assess the change in serum aspartate transaminase \[AST\] levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver disease and elevated serum levels of AST. Serum AST level will be used as a second marker of liver inflammation. To evaluate the response to 4.5mg GRI-0621 versus 6mg GRI-0621 in terms of the change in serum ALT levels from baseline measured at the different trial time points. To assess changes in serum cytokeratin 18 \[CK-18\] levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver disease. Serum CK-18 is used as a marker of hepatocyte cell death due to either necrosis or apoptosis. To measure Natural Killer T lymphocyte \[NKT\] cell activity at baseline and at Day 28 following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo. To describe the steady-state pharmacokinetics \[PK\] of GRI-0621 in patients with chronic liver disease. Exploratory objectives: To assess the effect, if any, that the investigational product may have on serum triglyceride levels.

Más ensayos de GRI

Todos los de GRI, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02949375), actualizada en ago 2019.