Metabolic Dysfunction-Associated Steatohepatitis study: ALN-CIDEB
Official title Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
ClinicalTrials.gov ID: NCT07631637
What this study is testing
What is ALN-CIDEB?
This is an investigational medicine being studied to see if it can help treat a liver disease called MASH.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if ALN-CIDEB lowers liver fat, injury, and scarring compared to a placebo. It also looks for side effects and how the body responds to the drug.
- Who it's for
- Adults diagnosed with fibrotic MASH, a liver disease linked to metabolic issues.
- What's involved
- Participants will receive either the study drug or a placebo. They will undergo tests to check liver health and monitor for any side effects.
- Time commitment
- The source text does not specify the total duration or the number of required visits.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- A diagnosis of MASH documented in the participant's medical history, or a clinical suspicion of MASH based on non-invasive biomarkers and clinical...
- Screening percutaneous liver biopsy demonstrating a NAFLD Activity Score (NAS) ≥4 and fibrosis stage F2 or F3 as described in the protocol
- Has a FibroScan Aspartate aminotransferase (FAST) score \>0.35 either at Screening Visit 1 or within approximately 3 months of Screening Visit 1 as...
You likely can't join if
- Known chronic liver disease other than Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD), as determined by the investigator as...
- Prior or current suspected or known drug-induced liver injury within approximately 1 year prior to Screening Visit 1
- History of liver transplantation, current placement on a liver transplant list, or MELD score \>12
- Known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion
- Prior, current, or planned future use of a Glucagon-Like Peptide-1 (GLP-1) receptor agonist-based therapy or any medication approved for the...
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- Pasadena, California, United States
- Rialto, California, United States
- Doral, Florida, United States
- Fort Myers, Florida, United States
- Miami, Florida, United States
- Indianapolis, Indiana, United States
- Topeka, Kansas, United States
- Marrero, Louisiana, United States
- Metairie, Louisiana, United States
- Danville, Pennsylvania, United States
- Nashville, Tennessee, United States
- Arlington, Texas, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Georgetown, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Sugar Land, Texas, United States
- San Juan, Puerto Rico
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States; Pasadena, California, United States; Rialto, California, United States; Doral, Florida, United States; Fort Myers, Florida, United States; Miami, Florida, United States and 15 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.