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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04565717
Other study ID # ALN-HSD-001
Secondary ID 2020-000847-29
Status Terminated
Phase Phase 1
First received
Last updated
Start date October 9, 2020
Est. completion date December 21, 2023

Study information

Verified date May 2024
Source Alnylam Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date December 21, 2023
Est. primary completion date January 6, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Belgium Clinical Trial Site Brussels
Bulgaria Clinical Trial Site Sofia
Turkey Clinical Trial Site Balçova
Turkey Clinical Trial Site Izmir
United Kingdom Clinical Trial Site Edinburgh
United Kingdom Clinical Trial Site London
United States Clinical Trial Site Baltimore Maryland
United States Clinical Trial Site Fleming Island Florida
United States Clinical Trial Site Hermitage Tennessee
United States Clinical Trial Site Marrero Louisiana
United States Clinical Trial Site San Antonio Texas
United States Clinical Trial Site San Antonio Texas
United States Clinical Trial Site San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Alnylam Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parts A and B: Frequency of Adverse Events Part A: Up to 3.5 months; Part B: up to 12.5 months
Primary Part C: Change from Baseline of Liver Hydroxysteroid 17ß Dehydrogenase 13 (HSD17B13) Messenger Ribonucleic Acid (mRNA) Baseline and Month 6
Secondary Part A: Area Under the Plasma Concentration-time Curve (AUC) for ALN-HSD and Potential Metabolites Day 1 predose and up to 48 hours postdose
Secondary Pat A: Maximum Plasma Concentration (Cmax) for ALN-HSD and Potential Metabolites Day 1 predose and up to 48 hours postdose
Secondary Part A: Fraction Excreted in Urine (fe) of ALN-HSD and Potential Metabolites Day 1 up to 24 hours postdose
Secondary Part B: Plasma Concentrations of ALN-HSD and Potential Major Metabolite(s) Day 1 and Month 3 predose and up to 4 hours postdose
Secondary Part B: Change from Baseline of Liver HSD17B13 mRNA Hepatic HSD17B13 mRNA will be measured by quantitative reverse-transcription polymerase chain reaction using ribonucleic acid (RNA) isolated from liver biopsy. Predose and up to 9 months postdose
Secondary Part C: Frequency of Adverse Events Up to 6 months
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