Please sign in to follow a disease.
Experimental drug ALN-CIDEB targets fatty liver in early trial
NCT ID NCT06836609
First seen Jun 25, 2026 · Last updated Jul 09, 2026 · Updated 3 times
Summary
This study tests an experimental drug called ALN-CIDEB in adults with fatty liver conditions (MASLD or MASH). The main goal is to check safety and tolerability, and also to see if the drug can reduce liver fat. About 132 participants will receive either the drug or a placebo. This is an early-stage trial, so results will help decide if larger studies are warranted.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ALN-CIDEB (an experimental drug)
- What this could lead to
- If it works, this could point toward a treatment that reduces liver fat and controls MASLD/MASH, potentially preventing progression to more severe liver damage.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with only 132 participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to show meaningful benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 132 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2025
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: 1. Part A: 18 to 55 years at Screening Visit 1 with MASLD, at Screening Visit 1 Part B: 18 to 65 years at Screening Visit 1 with a diagnosis of MASH, at Screening Visit 1 2. Body Mass Index (BMI) ≥30 kg/m2 and ≤40 kg/m2 at Screening Visit 1 3. Controlled-Attenuation Parameter (CAP) ≥285 dB/m by FibroScan during screening as described in the protocol 4. Liver fat content ≥8.5% by MRI-PDFF during screening 5. If on anti-hypertensive and/or lipid lowering medications and/or glucose lowering medications, must be on generally stable dose(s) for at least 12 weeks prior to screening and no changes to the dose(s) are anticipated during the study 6. Part B: A diagnosis of MASH documented in the participant's medical history, or a clinical suspicion of MASH based on non-invasive biomarkers (eg, evidence of fatty liver on imaging and elevated liver enzymes) and clinical risk factors, including having a history of 2 or more elements of metabolic syndrome, as defined in the protocol 7. Part B: Screening percutaneous liver biopsy NAFLD Activity Score (NAS) ≥3 and fibrosis stage, as defined in the protocol Key Exclusion Criteria: 1. Known historical or current diagnosis of portal hypertension or cirrhosis based on clinical assessment, imaging, and/or liver biopsy 2. Known historical or current diagnosis of other forms of chronic liver disease, as defined in the protocol 3. Prior or current suspected or known drug-induced liver injury within 1 year prior to screening 4. History of liver transplant, current placement on a liver transplant list, or Model for End-stage Liver Disease (MELD) score \>12 5. Contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions, or other contraindications for MRI 6. Liver stiffness measurement, laboratory parameter assessment, estimated Glomerular Filtration Rate (GFR), and evidence of uncontrolled hypertension, as defined in the protocol 7. Evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B Virus (HBV) infection, or Hepatitis C Virus (HCV) infection during screening, as described in the protocol 8. History of Type 1 Diabetes 9. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions, within approximately 5 years prior to randomization or planned during the study period NOTE: Other protocol-defined inclusion/exclusion criteria apply.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metabolic dysfunction-associated steatohepatitis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
4 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Adobe Clinical Research
RECRUITINGTucson, Arizona, 85712, United States
-
Arizona Liver Health
RECRUITINGChandler, Arizona, 85225, United States
-
Parexel International Early Phase Clinical Unit
RECRUITINGHarrow, London, HA1 3UJ, United Kingdom
-
Richmond Pharmacology Limited
RECRUITINGLondon, Greater London, SE1 1YR, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Underactive thyroid may worsen liver scarring in fatty liver disease
- Can exercise melt away liver fat?
- A blood test for liver trouble may flag hidden risk in sleep apnea patients
- Thyroid trouble may worsen liver scarring in fatty liver disease
- Can liver scarring predict heart trouble?
- Can a diabetes drug combo revive the Body's growth hormone axis and protect the liver?