Estudio de fase 2b aleatorizado, doble ciego, controlado con placebo y multicéntrico para evaluar la eficacia, la seguridad y la tolerabilidad de AZD2693 en participantes con esteatohepatitis no alcohólica (EHNA) no cirrótica con fibrosis que son portadores del alelo de riesgo PNPLA3 rs738409 148M

CompletadoFase 2ClinicalTrials.gov

ID: NCT05809934RENIS: IS004217Tipo: INTERVENTIONALInicio: 15 de mar de 2023Fin estimado: 29 de sept de 2025

Neumología Gastroenterología Enfermedades Infecciosas

Resumen

Estudio para evaluar la eficacia, la seguridad y la tolerabilidad de AZD2693 administrado mediante inyección subcutánea en participantes adultos con esteatohepatitis no alcohólica no cirrótica con fibrosis que son portadores del alelo de riesgo PNPLA3 148M.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Participants are eligible to be included in the study only if all the following criteria apply:
Age
Participant must be 18 to 75 years of age (inclusive) at the time of signing the informed consent.
Type of Participant and Disease Characteristics
Participants who are carriers for the PNPLA3 rs738409 148M risk allele.
Participants with histological evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 6 months before randomisation, or during screening, fulfilling both criteria:
Definitive NASH with NAS ≥ 4 with ≥ 1 in each component (ie, steatosis, lobular inflammation, and ballooning).
Presence of fibrosis stage F2 or F3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.

Criterios de exclusión

Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
Liver disease of other aetiologies (eg, alcoholic steatohepatitis; drug-induced, viral or autoimmune hepatitis; primary biliary cirrhosis; primary sclerosing cholangitis; hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease)
History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding.
Historical persistent or pre-existing renal disease marked by eGFR \< 40 mL/min/1.73 m2 (as defined by Kidney Disease Improving Global Outcomes guidelines).
Confirmed platelet count outside the normal range at the screening visit.
Any of the following confirmed at the screening visit:
ALT \> 5.0 × ULN
TBL \> 1.5 mg/dL (TBL \> 1.5 mg/dL is allowed if conjugated bilirubin is \< 1.5 × ULN)
INR \> 1.3
ALP \> 1.5 × ULN (unless the ALP elevation is not from hepatic origin as determined by a bone-specific ALP)

Intervenciones

drug

AZD2693

AZD2693 solution SC once per month

other

Placebo

Sodium chloride 0.9% solution SC once per month

Ubicaciones

Research Site

CABA, Argentina

Research Site

CABA, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Córdoba, Argentina

Research Site

La Plata, Argentina

Research Site

Mar del Plata, Argentina

Research Site

San Juan Bautista, Argentina

Patrocinadores

PrincipalAstraZeneca

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