A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Nonalcoholic Steatohepatitis, NASH
In brief
The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-HSD in healthy participants (Part A) and multiple doses of ALN-HSD in patients with NASH (Parts B and C).
Key facts
- Study ID
- NCT04565717
- Run by
- Alnylam Pharmaceuticals
- People needed
- 6
- Starts
- 2020-10-09
- Expected to finish
- 2023-12-21
- Last updated by the study team
- 2024-05-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Part A Only
- 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
You may not qualify if…
- Parts A, B and C:
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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