Metabolic Dysfunction-Associated Steatotic Liver Disease study: ALN-PNP vs Tirzepatide
Official title A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD
ClinicalTrials.gov ID: NCT07527910
What this study is testing
What is ALN-PNP?
ALN-PNP is an investigational medicine being studied to see if it can help treat fatty liver disease (MASLD). It is designed to lower the amount of a specific protein called PNPLA3 in the liver, which may help reduce liver fat.
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
- This study aims to see if the new drug can reduce fat in the liver and to check for any side effects.
- Who it's for
- The study is looking for adults who have a specific genetic form of fatty liver disease.
- What's involved
- Participants will receive the new liver drug, and some will also take a medicine used for blood sugar and weight control.
- Time commitment
- The source text does not specify the total duration or the number of visits required.
- Phase 2: a mid-size study of how well it works
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
- Homozygous for the PNPLA3 p.I148M genotype
- Liver fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥15% at visit 3
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤3 × Upper Limit of Normal (ULN) as described in the protocol
- On a stable dose of tirzepatide at randomization (≥5 mg weekly) Key
You likely can't join if
- Evidence or diagnosis of portal hypertension or cirrhosis from any cause, including cirrhosis due to MASH, as determined by the investigator, based...
- Known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol
- Contraindications to MRI examinations, including but not limited to persons with MRI-incompatible cardiac pacemaker and implants made of metal...
- Any contraindication listed in the Zepbound United States Prescribing Information (USPI), as defined in the protocol NOTE: Other protocol-defined...
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- Coronado, California, United States
- Pasadena, California, United States
- Jupiter, Florida, United States
- Miami, Florida, United States
- Metairie, Louisiana, United States
- Austin, Texas, United States
- Georgetown, Texas, United States
- San Antonio, Texas, United States
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; Coronado, California, United States; Pasadena, California, United States; Jupiter, Florida, United States; Miami, Florida, United States; Metairie, Louisiana, United States and 3 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.