A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
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Voluntary — you can stop anytime
What is this study?
This study is researching an experimental drug called ALN-CIDEB, also referred to as "study drug". The study is focused on participants with metabolic dysfunction-associated steatotic liver disease (MASLD) (Part A) and metabolic dysfunction-associated steatohepatitis (MASH) (Part B).
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
This study is researching an experimental drug called ALN-CIDEB, also referred to as "study drug". The study is focused on participants with metabolic dysfunction-associated steatotic liver disease (MASLD) (Part A) and metabolic dysfunction-associated steatohepatitis (MASH) (Part B). MASLD and MASH are long-lasting liver conditions caused by having too much fat in the liver. The aim of the study is to see how safe and tolerable the study drug is. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How the study drug works to change liver fat content * How much study drug and study drug metabolites (byproducts of the body breaking down the study drug) are in the blood at different times
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults aged 18 to 55 (MASLD/Part A) or 18 to 65 (MASH/Part B) at the screening visit
- •BMI between 30 and 40 kg/m2 at screening
- •For Part A: MASLD with CAP score at or above 285 dB/m by FibroScan and liver fat at or above 8.5% by MRI-PDFF
- •For Part B: diagnosed MASH (or a clinical suspicion based on non-invasive biomarkers and risk factors, including having 2 or more elements of metabolic syndrome)
- •For Part B: screening liver biopsy with NAS score of at least 3 and a fibrosis stage as defined in the protocol
🚫 You may not be able to join if…
- •Known portal hypertension or cirrhosis (current or past) based on clinical assessment, imaging, and/or liver biopsy
- •Known current or past chronic liver disease other than the ones being studied
- •Drug-induced liver injury within 1 year before screening
- •A history of liver transplant, being on a liver transplant list, or MELD score greater than 12
- •Certain MRI limits (for example, a cardiac pacemaker or metal implants, severe claustrophobia, or other MRI contraindications)
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults in the study age range (18–55 for MASLD and 18–65 for MASH).
- ✓BMI between 30 and 40.
- ✓Need evidence of metabolic dysfunction–associated fatty liver disease/steatohepatitis, including scan/lab findings and (for MASH) biopsy criteria.
- ✓Cannot have cirrhosis/portal hypertension or other chronic liver diseases as defined by the protocol.
- ✓Not on unsafe MRI/CKD or other protocol-level uncontrolled issues, and certain viral hepatitis/HIV are excluded.
- !Some conditions may not be a fit: High blood pressure
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- •Some participants receive a . The study team tells you your chances of getting the active treatment before you decide.
- •You'd be placed into a group by chance, like a coin flip — this keeps the study fair.
- •This study is , so results can't be swayed by expectations. Your medical team always knows what you're getting.
- •There are 2 groups in this study.
What to expect, step by step
· This study lasts about 48 weeks (~11 months)- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
About 48 weeksIf you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Drug: ALN-CIDEB
- Drug: Placebo
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
Who's running this study?
Sponsor
Regeneron Pharmaceuticals
Overseen by Clinical Trial Management
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
This study is researching an experimental drug called ALN-CIDEB, also referred to as "study drug". The study is focused on participants with metabolic dysfunction-associated steatotic liver disease (MASLD) (Part A) and metabolic dysfunction-associated steatohepatitis (MASH) (Part B).
Is it safe? Who makes sure of that?+
This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT06836609 · Locations: Arizona · Greater London · London