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Official title 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)
ClinicalTrials.gov ID: NCT05648214
What this study is testing
What is ALN-PNP?
ALN-PNP is an investigational medicine, being studied as a potential treatment for healthy volunteers.
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 is researching an experimental drug called ALN-PNP (called "study drug"). This is a first in human study.
- 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. Healthy volunteers may be eligible.
You may be able to join if
- Key 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...
You likely can't join if
- Part A:
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological...
- 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...
- 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
See the full eligibility criteria
- Key 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...
- Liver fat content ≥8.5% as measured by MRI-PDFF at screening visit 3 Key
- Part A:
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological, or dermatologic disease, as assessed by the investigator, that may...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
- Los Angeles, California, United States
- Miami, Florida, United States
- Marrero, Louisiana, United States
- Houston, 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 - 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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, California, United States; Los Angeles, California, United States; Miami, Florida, United States; Marrero, Louisiana, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.