Study to Evaluate ALN-CIDEB in Adults With Fibrotic Alcohol-Associated Liver Disease (ALD)
A legfontosabb adatok
- Fázis
- 2. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 75 év között vagy?
Forrás: NCT07933328: ki vehet részt
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Regeneron Pharmaceuticals
- Azonosító
- NCT07933328EU 2026-527097-37-00
- A regiszteradat frissítve
- 2026. november 12.
- Eredeti leírás
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called alcohol-associated liver disease (ALD). ALD is a type of liver disease caused by drinking alcohol at levels that are harmful to the body. The study will also test ALN-CIDEB in participants who are known to have metabolic dysfunction- and alcohol- associated liver disease (MetALD), a subgroup of people that have features of both ALD and metabolic dysfunction-associated steatotic liver disease (MASLD).A teljes eredeti leírásKevesebb
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALN-CIDEB in Adults With Alcohol-Associated Liver Disease (ALD) With Moderate to Advanced Fibrosis
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called alcohol-associated liver disease (ALD). ALD is a type of liver disease caused by drinking alcohol at levels that are harmful to the body. The study will also test ALN-CIDEB in participants who are known to have metabolic dysfunction- and alcohol- associated liver disease (MetALD), a subgroup of people that have features of both ALD and metabolic dysfunction-associated steatotic liver disease (MASLD).
The study will compare 2 different dose regimens of ALN-CIDEB with placebo (something that looks like the study drug but doesn't contain any medicine) to understand how well ALN-CIDEB works to lower the amount of fat in the liver.
The study is looking at:
* What side effects ALN-CIDEB might cause * How well ALN-CIDEB works to change liver fat and stiffness of the liver * How ALN-CIDEB could affect the liver proteins
Bevonási feltételek: Has a diagnosis of alcohol-associated liver disease (with or without MetALD), as determined by the investigator; Has a liver stiffness measurement ≥7 and <20 kilopascal (kPa) by FibroScan at Screening Visit 1; Has a controlled attenuation parameter ≥285 decibels per meter (dB/m) by FibroScan at Screening Visit 1; Has liver fat content ≥8.5% by MRI-PDFF at Screening Visit 2.
Kizáró feltételek: Has known chronic liver disease other than MetALD or ALD, as determined by the investigator and as defined in the protocol; Has history of or current alcohol-associated hepatitis (AH) at screening, as determined by the investigator; NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply.