Phase
Condition
Primary Biliary Cholangitis
Liver Disease
Healthy Volunteers
Treatment
ALN-PNP - Part A
ALN-PNP - Part B
Placebo (PB)
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key 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 biologicgrandparents who are ethnically Japanese and born in Japan
Have maintained a Japanese lifestyle, with no significant change since leavingJapan, including having access to Japanese food and adhering to a Japanese diet
Be living <10 years outside of Japan
Has a body mass index 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 visitand approximately within 24 hours prior to administration of study drug
Part B (Participants with NAFLD):
From 18 to 65 years of age
Body mass index (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) andBMI from 27.0 kg/m2 to 40.0 kg/m2, inclusive, for any other ethnicity at screeningvisit 1
Liver fat content ≥8.5% as measured by MRI-PDFF at screening visit 3
Exclusion
Key Exclusion Criteria:
Part A:
History of clinically significant cardiovascular, respiratory, hepatic, renal,gastrointestinal, endocrine, hematological, psychiatric, neurological, ordermatologic disease, as assessed by the investigator, that may confound the resultsof 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 ofthe study or poses an additional risk to the participant by their participation inthe study
Hospitalized for any reason within 30 days of the screening visit
Using the Modification of Diet in Renal Disease equation, has a glomerularfiltration rate as described in the protocol at the screening visit
Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or totalbilirubin above the upper limit of normal (ULN) range
Is a current smoker or former smoker, including e-cigarettes, who stopped smokingwithin 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 ribonucleic acid (RNA) test at thescreening visit
Part B:
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
Bariatric surgery within approximately 5 years prior or planned during the studyperiod
Has lost or gained more than 4.0% body weight over the 3 months prior to or duringthe screening period
Has known human immunodeficiency virus (HIV) infection, evidence of current orchronic hepatitis B virus (HBV) infection, or current or chronic hepatitis C virus (HCV) infection, as defined in the protocol
NOTE: Other protocol defined inclusion / exclusion criteria apply
Study Design
Connect with a study center
California Clinical Trials Medical Group
Glendale, California 91206
United StatesSite Not Available
Velocity Clinical research
Los Angeles, California 90057
United StatesSite Not Available
Genoma Research Group ,Inc
Miami, Florida 33173
United StatesSite Not Available
Med Research of Florida,LLC
Miami, Florida 33186
United StatesSite Not Available
Tandem Clinical Research
Marrero, Louisiana 70072
United StatesSite Not Available
Pioneer Research Solutions
Houston, Texas 77099
United StatesSite Not Available
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