A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)
NCT ID: NCT04565717
Last Updated: 2024-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
6 participants
INTERVENTIONAL
2020-10-09
2023-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part A: ALN-HSD
Participants will be administered a single dose of ALN-HSD.
ALN-HSD
ALN-HSD will be administered by subcutaneous (SC) injection.
Part A: Placebo
Participants will be administered a single dose of ALN-HSD-matching placebo.
Placebo
Normal saline (0.9% NaCl) matching volume of ALN-HSD doses will be administered SC.
Part B: ALN-HSD
Participants will be administered multiple doses of ALN-HSD.
ALN-HSD
ALN-HSD will be administered by subcutaneous (SC) injection.
Part B: Placebo
Participants will be administered multiple doses of ALN-HSD-matching placebo.
Placebo
Normal saline (0.9% NaCl) matching volume of ALN-HSD doses will be administered SC.
Part C: ALN-HSD
Participants will be administered multiple doses of ALN-HSD.
ALN-HSD
ALN-HSD will be administered by subcutaneous (SC) injection.
Interventions
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ALN-HSD
ALN-HSD will be administered by subcutaneous (SC) injection.
Placebo
Normal saline (0.9% NaCl) matching volume of ALN-HSD doses will be administered SC.
Eligibility Criteria
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Inclusion Criteria
* Has body mass index (BMI) ≥18 kg/m\^2 and ≤28 kg/m\^2
* Has normal 12-lead electrocardiogram (ECG)
* Parts B and C Only:
* Has BMI ≥18 kg/m\^2 and ≤40 kg/m\^2
* Has a diagnosis of NASH documented in the patient's medical history or a clinical suspicion of NASH based on defined study criteria
* Has screening liver biopsy with NASH activity score (NAS) score of ≥3 per NASH Clinical Research Network (CRN) criteria
Exclusion Criteria
* Has any clinical safety laboratory result considered clinically significant and unacceptable by the Investigator
* Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
* Has known history or evidence of drug abuse, within 12 months prior to screening
* Has evidence of other forms of known chronic liver disease
* Has recently received an investigational agent
* Has any uncontrolled or serious disease, medical or surgical condition that my interfere with participation or data interpretation
* Has excessive alcohol intake for ≥ 3 months during past year
* Has history of intolerance to SC injection(s)
* Has international normalized ratio (INR) \>1.2
* Has platelet count \<140x10\^9/L
* Part A Only
* Has systolic blood pressure (BP) \>140 mmHg and diastolic \>90 mmHg;
* Has used certain prescription drugs within last 14 days prior to screening
* Has used certain over the counter (OTC) medication within 7 days prior to screening
* Has estimated glomerular filtration rate (GFR) \<90 mL/min/1.73m\^2 at screening
* Parts B and C Only
* Has abnormal ECG
* Has changes in certain prescription medications defined in the protocol within the specified timeframe prior to screening
* Has GFR\<45ml/min/1.73m\^2
18 Years
65 Years
ALL
Yes
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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Clinical Trial Site
Fleming Island, Florida, United States
Clinical Trial Site
Marrero, Louisiana, United States
Clinical Trial Site
Baltimore, Maryland, United States
Clinical Trial Site
Hermitage, Tennessee, United States
Clinical Trial Site
San Antonio, Texas, United States
Clinical Trial Site
San Antonio, Texas, United States
Clinical Trial Site
San Antonio, Texas, United States
Clinical Trial Site
Brussels, , Belgium
Clinical Trial Site
Sofia, , Bulgaria
Clinical Trial Site
Balçova, , Turkey (Türkiye)
Clinical Trial Site
Izmir, , Turkey (Türkiye)
Clinical Trial Site
Edinburgh, , United Kingdom
Clinical Trial Site
London, , United Kingdom
Countries
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Other Identifiers
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2020-000847-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALN-HSD-001
Identifier Type: -
Identifier Source: org_study_id
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