Status:
COMPLETED
A Trial to Learn if Receiving ALN-PNP siRNA is Safe and Well Tolerated, and How it Works in Adult Participants With Nonalcoholic Fatty Liver Disease (NAFLD) and a Genetic Risk Factor
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Nonalcoholic Fatty Liver Disease (NAFLD)
Nonalcoholic Steatohepatitis (NASH)
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is researching an experimental drug called ALN-PNP. This study is focused on participants who are known to have nonalcoholic fatty liver disease (NAFLD), and a specific variant of the patat...
Eligibility Criteria
Inclusion
- Key
- Participants from 18 (or country's legal age of adulthood) to 65 years of age, inclusive, at screening visit 1
- Body mass index (BMI) from 23.0 kg/m\^2 to 40.0 kg/m\^2, inclusive, for East Asians (including but not limited to South Koreans, Chinese, Taiwanese, and Japanese) and BMI from 27.0 kg/m\^2 to 40.0 kg/m\^2, inclusive, for any other ethnicity at screening visit 1
- Meets genotype criteria for the rs738409:G PNPLA3 risk allele: homozygotes (for Part A and Part B) or heterozygotes (optional Part C); p.I148M variant (PNPLA3 rs738409:G \[p.I148M\]) at screening visit 1
- Liver fat content ≥8.5% as measured by MRI-PDFF at screening visit 3
- Generally stable diet (based on participant's recall) for at least 3 months prior to the screening visit
- Key
Exclusion
- Evidence of other forms of known chronic liver disease, as defined in the protocol
- Has a contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made out of metal (for example, cochlear implant, nerve stimulators, magnetic vascular clips, and metallic heart valve), severe claustrophobia, or other contraindications for MRI
- Is taking a medication to treat a co-morbid condition that is not permitted during the study
- Has any laboratory parameter assessments at screening, as defined in the protocol
- History of Type 1 diabetes
- Bariatric surgery within approximately 5 years prior or planned during the study period
- Has lost or gained more than 4.0% body weight over the 3 months prior to or during the screening period
- Has known human immunodeficiency virus (HIV) infection, evidence of current or chronic hepatitis B virus (HBV) infection, or current or chronic hepatitis C virus (HCV) infection, as defined in the protocol
- Was hospitalized (ie, \>24 hours) for any reason within 30 days of the screening visit
- Note: Other protocol defined Inclusion/Exclusion Criteria apply
Key Trial Info
Start Date :
May 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06024408
Start Date
May 21 2024
End Date
July 7 2025
Last Update
July 31 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Chungbuk National University Hospital
Cheongju-si, Chungcheong Buk-do, South Korea, 28644
2
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea, 13496
3
Seoul National University Hospital
Seoul, South Korea, 03080
4
Severance Hospital
Seoul, South Korea, 03722