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NCT05648214 · Regeneron Pharmaceuticals

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)

What this study is about

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.

View original scientific description

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.

Interventions

DRUG

ALN-PNP

Administered per the protocol

DRUG

Placebo (PB)

Administered per the protocol

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Time frame: Up to Day 337

Severity of TEAEs

Time frame: Up to Day 337

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Part A (Healthy Adults):
  • From 18 to 55 years of age
  • For Japanese cohorts ONLY; the Japanese participant must:
  • Be Japanese, born in Japan, and have both biologic parents and 4 biologic grandparents who are ethnically Japanese and born in Japan
  • Have maintained a Japanese lifestyle, with no significant change since leaving Japan, including having access to Japanese food and adhering to a Japanese diet
  • Be living \<10 years outside of Japan
  • Has a Body Mass Index (BMI) between 18 and 32 kg/m\^2, inclusive, at the screening visit
  • Is judged by the investigator to be in good health, as described in the protocol
  • Is in good health based on laboratory safety testing obtained at the screening visit and approximately within 24 hours prior to administration of study drug Part B and Part C (Participants with MASLD):
  • Part B: From 18 to 65 years of age
  • Part C: From 18 to 75 years of age
  • BMI from 23.0 kg/m2 to 40.0 kg/m2, inclusive, for East Asians (including but not limited to South Koreans, Chinese, Taiwanese, and Japanese) and BMI from 27.0 kg/m2 to 40.0 kg/m2, inclusive, for any other ethnicity at screening visit 1
  • Liver fat content ≥8.5% as measured by MRI-PDFF at screening visit 3 Key

Exclusion criteria

  • History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological, or dermatologic disease, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation
  • Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
  • Hospitalized for any reason within 30 days of the screening visit
  • Using the Modification of Diet in Renal Disease equation, has a glomerular filtration rate as described in the protocol at the screening visit
  • Has Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) or total bilirubin above the Upper Limit of Normal (ULN) range
  • Is a current smoker or former smoker, including e-cigarettes, who stopped smoking within 3 months prior to the screening visit
  • Has a history of alcohol or drug abuse per investigator opinion
  • Is positive for hepatitis C antibody and if so, positive for qualitative (ie, detected or not detected) Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) test at the screening visit Part B and Part C:
  • Evidence of other forms of known chronic liver disease, as defined in the protocol
  • Has a contraindication to MRI examinations, as defined in the protocol
  • History of Type 1 diabetes
  • 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 HCV infection, as defined in the protocol
  • Bariatric surgery within approximately 5 years (Part B) or 3 years (Part C) prior or planned during the study period NOTE: Other protocol defined inclusion / exclusion criteria apply

Where

  • Glendale, California
  • Los Angeles, California
  • Miami, Florida
  • Marrero, Louisiana
  • Houston, Texas

Related conditions & keywords

Healthy VolunteersMetabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Liver steatosisFibrosisHepatocytesNon-Alcoholic Steatohepatitis (NASH)Non-Alcoholic Fatty Liver Disease (NAFLD)Metabolic dysfunction-Associated Steatohepatitis (MASH)

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations

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1 of 172 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

COMPLETED

Glendale

California

Location available
RECRUITING

Los Angeles

California

Location available
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Marrero

Louisiana

Location available
RECRUITING

Houston

Texas

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Looking for Healthy Volunteers Treatment in Glendale?

Join others in California exploring innovative treatment options through clinical research

Healthy Volunteers Treatment Options in Glendale, California

If you're searching for Healthy Volunteers treatment in Glendale, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Glendale, Los Angeles, Miami and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Healthy Volunteers. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 172 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Healthy Volunteers?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Healthy Volunteers

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Healthy Volunteers Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05648214. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.