RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)

This study is exploring a new drug, ALN-CIDEB, for adults with two liver conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-Associated Steatohepatitis (MASH). These conditions mean there's too much fat in the liver. The main goal is to find out if the drug is safe and well-tolerated. Researchers will also look for any side effects and see how the drug might reduce liver fat. They'll monitor how the body uses and breaks down the drug over time to understand its effects better. This research is an early-stage study to gather important information about this potential new treatment.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Regeneron Pharmaceuticals

Enrolment target

132

Start

28 Apr 2025

Estimated completion

15 May 2027

Metabolic Dysfunction-Associated Steatotic Liver Disease Metabolic Dysfunction-Associated Steatohepatitis

What is this study about?

This research study is looking into a new medication, called ALN-CIDEB, for people who have certain liver conditions. These conditions are known as Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-Associated Steatohepatitis (MASH). In simple terms, both MASLD and MASH happen when too much fat builds up in the liver. Over time, MASH can be more serious, leading to inflammation and liver damage. This study is an important step in trying to find new ways to treat these conditions.

The main aim of this study is to see how safe the new drug, ALN-CIDEB, is for people to take and how well their bodies cope with it. Researchers will be very careful to watch for any unwanted effects, often called side effects. They also want to understand if the drug helps to reduce the amount of fat in the liver and how the body processes the medication after it's taken. Understanding these things is crucial for developing effective and safe new treatments.

Because this is an early-stage study, it helps doctors and scientists learn key information about new medicines. It's about gathering facts on how the drug behaves in the body and if it shows promise for treating MASLD and MASH. The information learned from studies like this helps pave the way for future research and potentially new treatment options for people living with these liver conditions.

Key takeaways

This study explores a new drug (ALN-CIDEB) for fatty liver conditions (MASLD/MASH).
Its main goal is to check how safe the drug is and if it causes side effects.
Researchers will also see if the drug reduces liver fat.
It's an early-stage study, focused on gathering crucial information.
Participation involves regular clinic visits, tests, and potentially a liver biopsy.

Who may be eligible?

To join this study, you would generally need to be an adult between 18 and 65 years old. For both groups, you'd need to have a certain amount of fat in your liver, which will be checked using special tests. You'd also need to have a Body Mass Index (BMI) usually between 30 and 40.

If you're already taking medicines for conditions like high blood pressure, high cholesterol, or diabetes, it's important that your doses have been stable for at least 12 weeks before the study starts and aren't expected to change during the study. If you have MASH, your diagnosis would need to be confirmed, possibly through a liver biopsy, and you should not have advanced liver disease like cirrhosis.

Some things would prevent you from taking part. For example, if you have a history of advanced liver disease, such as cirrhosis or portal hypertension, or if you've ever had a liver transplant. You also can't take part if you have certain metal implants or severe claustrophobia that would make getting an MRI scan unsafe or impossible.

Quick self-check

Are you an adult between 18 and 65 years old?
Do you have a diagnosis of MASLD or MASH?
Is your Body Mass Index (BMI) between 30 and 40?
Are you willing to have special scans to check your liver fat and stiffness?
Do you have advanced liver disease like cirrhosis? (If yes, you likely can't join.)
Are you able to have an MRI scan? (No metal implants or severe claustrophobia)

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will either receive the study drug, ALN-CIDEB, or a placebo (a dummy drug that looks like the real thing but has no active medicine) – you won't know which one you're getting. You would have several visits to the clinic for check-ups and sample collections, such as blood tests, to see how you're responding to the treatment and to monitor your health. You'll also undergo special scans like MRI-PDFF and FibroScan to measure the fat and stiffness in your liver. These scans are important for understanding how the drug might be affecting your liver. Your total time in the study will be discussed by the study team, along with details about how often you'd need to come in and what each visit would involve.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from taking the study drug, but the information gained could help others in the future by leading to new treatments for MASLD and MASH. Possible risks include side effects from the study drug, which will be carefully monitored. There are also risks associated with various tests, such as blood draws or a liver biopsy, though these are generally small. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Arizona Liver Health
Chandler, United States· Recruiting
Richmond Pharmacology Limited
London, United Kingdom· Recruiting
Parexel International Early Phase Clinical Unit
Harrow, United Kingdom· Recruiting

Common questions

What are MASLD and MASH?

MASLD and MASH are conditions where too much fat builds up in the liver. MASH is more serious, as it involves inflammation and can cause liver damage.

What is ALN-CIDEB?

ALN-CIDEB is an experimental drug, meaning it's still being tested to see if it's safe and effective for treating certain liver conditions.

What is a placebo?

A placebo is a substance that looks exactly like the study drug but does not contain any active medicine. It helps researchers compare the real drug's effects.

Will I know if I'm getting the drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know if you're receiving the active drug or the placebo until the study is over.

What kind of tests will I have?

You'll have blood tests, special liver scans like MRI-PDFF and FibroScan, and potentially a liver biopsy to check your liver health and how the drug is working.

How to find out more

Clinical Trials Administrator

clinicaltrials@regeneron.com 844-734-6643 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.