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RNAi Therapeutics
ALN-PNP for Healthy Subjects
Verified Trial
Phase 1
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to day 253
Summary
This trial is testing a new drug called ALN-PNP on healthy people and those with a specific liver condition (NAFLD) and gene variant. The goal is to see if the drug is safe, tolerable, and effective in reducing liver fat. Researchers are also studying how the body processes the drug.
Who is the study for?
This trial is for healthy adults, including specific criteria for Japanese participants such as being born in Japan with Japanese parents and grandparents, living a Japanese lifestyle, and not having lived outside of Japan for more than 10 years. Participants must have a BMI between 18-32 and be in good health based on lab tests. Smokers or recent smokers, those with significant diseases or abnormal lab results are excluded.
What is being tested?
The study is testing the safety and how well people tolerate ALN-PNP when given once to healthy adults compared to a placebo. It will also look at how the body processes ALN-PNP, its effects on immune response, and any changes it might cause in blood lipid levels.
What are the potential side effects?
Since this is an early-stage trial to determine safety and tolerability, potential side effects are not fully known yet but may include typical drug-related reactions like injection site discomfort, allergic reactions, fatigue or changes in blood test results.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to day 253
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to day 253
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in apolipoprotein A1 (ApoA1) over time
Change in high-density lipoprotein (HDL) over time
Change in high-density lipoprotein cholesterol (HDL-C) over time
+4 moreTrial Design
12Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: ALN-PNP Dose 5Experimental Treatment1 Intervention
Up to 32 Participants Randomized 1:1:1:1 resulting in 8 participants per arm
Group II: Part B: ALN-PNP Dose 4Experimental Treatment1 Intervention
Up to 32 Participants Randomized 1:1:1:1 resulting in 8 participants per arm
Group III: Part B: ALN-PNP Dose 3Experimental Treatment1 Intervention
Up to 32 Participants Randomized 1:1:1:1 resulting in 8 participants per arm
Group IV: Part A: Optional ALN-PNP Dose 5 or PBExperimental Treatment2 Interventions
8 Participants, Randomized 6:2
This is an optional cohort, if there is a need for additional dose characterization of ALN-PNP.
Group V: Part A: JPN ALN-PNP Dose 5 or PBExperimental Treatment2 Interventions
8 Japanese Participants only, Randomized 6:2
Group VI: Part A: JPN ALN-PNP Dose 4 or PBExperimental Treatment2 Interventions
8 Japanese Participants only, Randomized 6:2
Group VII: Part A: ALN-PNP Dose 5 or PBExperimental Treatment2 Interventions
8 Participants, Randomized 6:2
Group VIII: Part A: ALN-PNP Dose 4 or PBExperimental Treatment2 Interventions
8 Participants, Randomized 6:2
Group IX: Part A: ALN-PNP Dose 3 or PBExperimental Treatment2 Interventions
8 Participants, Randomized 6:2
Group X: Part A: ALN-PNP Dose 2 or PBExperimental Treatment2 Interventions
8 Participants, Randomized 6:2
Group XI: Part A: ALN-PNP Dose 1 or PBExperimental Treatment2 Interventions
8 Participants, Randomized 6:2
Group XII: Part B: PlaceboPlacebo Group1 Intervention
Up to 32 Participants Randomized 1:1:1:1 resulting in 8 participants per arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo (PB)
2004
Completed Phase 2
~90
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) often target reducing liver fat content and improving metabolic functions. Investigational drugs like ALN-PNP aim to achieve these goals by potentially modulating lipid metabolism and reducing hepatic steatosis.
Other treatments, such as GLP-1 receptor agonists (e.g., liraglutide) and PPAR agonists (e.g., pioglitazone), work by improving insulin sensitivity and reducing inflammation, which are crucial for managing NAFLD. These mechanisms are important for NAFLD patients as they address the root causes of the disease, potentially preventing progression to more severe liver conditions like fibrosis or cirrhosis.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
671 Previous Clinical Trials
385,747 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
284 Previous Clinical Trials
254,821 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of alcohol or drug abuse, according to the doctor's opinion.You are currently smoking or have recently quit smoking (including e-cigarettes) within the past 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Part A: ALN-PNP Dose 3 or PB
- Group 2: Part B: Placebo
- Group 3: Part A: JPN ALN-PNP Dose 4 or PB
- Group 4: Part A: ALN-PNP Dose 2 or PB
- Group 5: Part A: ALN-PNP Dose 4 or PB
- Group 6: Part A: ALN-PNP Dose 5 or PB
- Group 7: Part A: Optional ALN-PNP Dose 5 or PB
- Group 8: Part A: JPN ALN-PNP Dose 5 or PB
- Group 9: Part B: ALN-PNP Dose 3
- Group 10: Part B: ALN-PNP Dose 4
- Group 11: Part B: ALN-PNP Dose 5
- Group 12: Part A: ALN-PNP Dose 1 or PB
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.