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NCT05648214 · ClinicalTrials.gov registry record · Phase 1
A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Phase 1 study of Healthy Volunteers and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 156
- Enrollment target
- 6
- Study locations
NCT05648214 is a Phase 1 study of Healthy Volunteers and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 156 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (68% lower). The trial reports 6 study locations across 4 states.
The verdict
NCT05648214, a Phase 1 study of Healthy Volunteers and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 156 participants
- Enrollment target
- 6
- Study locations
Study Summary
This study is researching an experimental drug called ALN-PNP (called "study drug"). This is a first in human study. The study drug is not approved by any public health agency such as the United States Food and Drug Administration (FDA) for any kind of treatment. This study consists of 3 parts. Part A is focused on healthy participants. Parts B and C of the study are focused on participants who are known to have MASLD and a specific variant of the PNPLA3 gene. The aim of the study is to see how safe, tolerable and effective the study drug is. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug (Parts A, B and C) * How much study drug (Parts A, B and C) and study drug metabolites (byproduct of the body breaking down the study drug) (Parts B and C) are in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) (Part A, B and C) * Explore impact of Japanese ethnicity on safety and PK (Pharmacokinetics, or study of what the body does to the drug) of single doses of ALN-PNP over time (Part A) * How the study drug works to change liver fat content in MASLD (Part B and C) * Better understanding of the study drug and MASLD (Part B and C)
Conditions Studied
Interventions
- DRUG ALN-PNP
- DRUG Placebo (PB)
Study Locations (6)
California
- California Clinical Trials Medical Group - Glendale
- Velocity Clinical research - Los Angeles
Florida
- Genoma Research Group, Inc - Miami
- Med Research of Florida, LLC - Miami
Louisiana
- Tandem Clinical Research - Marrero
Texas
- Pioneer Research Solutions - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2022-12-27 |
| Est. Completion | 2027-08-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05648214
The ClinicalTrials.gov registry entry for NCT05648214 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (68% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which ALN-PNP is the first listed.
NCT05648214 reports 6 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Louisiana.
Frequently Asked Questions
What is clinical trial NCT05648214 about?
NCT05648214 is a clinical study titled "A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)". This study is researching an experimental drug called ALN-PNP (called "study drug"). This is a first in human study. The study drug is not approved by any public health agency such as the United States Food and Drug Administration (FDA) for any kind of treatment. This study consists of 3 parts. Par...
What is the current status of trial NCT05648214?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 156 participants. The study started on 2022-12-27. Estimated completion is 2027-08-10.
What conditions does trial NCT05648214 study?
This clinical trial studies the following conditions: Healthy Volunteers, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
What interventions are being tested in trial NCT05648214?
The interventions under investigation include: ALN-PNP (DRUG), Placebo (PB) (DRUG).
Who is sponsoring clinical trial NCT05648214?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05648214 being conducted?
This trial has 6 study locations across California, Florida, Louisiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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