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A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)

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ClinicalTrials.gov Identifier: NCT04565717
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

Study Description
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Brief 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 (Part B).

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis NASH Drug: ALN-HSD Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 2-Part Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-HSD in Healthy Adult Subjects and Multiple Dose ALN-HSD in Adult Patients With Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : October 9, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A: ALN-HSD
Participants will be administered a single dose of ALN-HSD.
 Drug: ALN-HSD
ALN-HSD will be administered by subcutaneous (SC) injection.
Placebo Comparator: Part A: Placebo
Participants will be administered a single dose of ALN-HSD-matching placebo.
 Drug: Placebo
Normal saline (0.9% NaCl) matching volume of ALN-HSD doses will be administered SC.
Experimental: Part B: ALN-HSD
Participants will be administered multiple doses of ALN-HSD.
 Drug: ALN-HSD
ALN-HSD will be administered by subcutaneous (SC) injection.
Placebo Comparator: Part B: Placebo
Participants will be administered multiple doses of ALN-HSD-matching placebo.
 Drug: Placebo
Normal saline (0.9% NaCl) matching volume of ALN-HSD doses will be administered SC.


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of Adverse Events [ Time Frame: Part A: Up to 3.5 months; Part B: up to 12.5 months ]

Secondary Outcome Measures :
  1. Area Under the Plasma Concentration-time Curve (AUC) for ALN-HSD and Potential Metabolites [ Time Frame: Part A: Day 1 predose and up to 48 hours postdose; Part B: Day 1 and Month 3 predose and up to 4 hours postdose ]
  2. Maximum Plasma Concentration (Cmax) for ALN-HSD and Potential Metabolites [ Time Frame: Part A: Day 1 predose and up to 48 hours postdose; Part B: Day 1 and Month 3 predose and up to 4 hours postdose ]
  3. Fraction Excreted in Urine (fe) of ALN-HSD and Potential Metabolites [ Time Frame: Part A and B: Day 1 up to 24 hours postdose ]
  4. Part B: Change from Baseline of Liver Hydroxysteroid 17β Dehydrogenase 13 (HSD17B13) Messenger Ribonucleic Acid (mRNA) [ Time Frame: Predose and up to 9 months postdose ]
    Hepatic HSD17B13 mRNA will be measured by quantitative reverse-transcription polymerase chain reaction using ribonucleic acid (RNA) isolated from liver biopsy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

  • Part B 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 and B:

    • 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) ≤60 mL/min/1.73m^2 at screening

  • Part B 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565717


Contacts
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Contact: Alnylam Clinical Trial Information Line 1-877-ALNYLAM clinicaltrials@alnylam.com
Contact: Alnylam Clinical Trial Information Line 1-877-256-9526 clinicaltrials@alnylam.com

Locations
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United States, California
Clinical Trial Site Recruiting
Huntington Park, California, United States, 90255
Clinical Trial Site Recruiting
Newport Beach, California, United States, 92660
United States, Florida
Clinical Trial Site Recruiting
Inverness, Florida, United States, 34452
Clinical Trial Site Recruiting
Maitland, Florida, United States, 32751
Clinical Trial Site Recruiting
Miami, Florida, United States, 33135
United States, Iowa
Clinical Trial Site Recruiting
Iowa City, Iowa, United States, 52242
United States, Louisiana
Clinical Trial Site Recruiting
Marrero, Louisiana, United States, 70072
United States, Maryland
Clinical Trial Site Recruiting
Baltimore, Maryland, United States, 21202
United States, Michigan
Clinical Trial Site Recruiting
Detroit, Michigan, United States, 48202
United States, Mississippi
Clinical Trial Site Recruiting
Jackson, Mississippi, United States, 39216
United States, Tennessee
Clinical Trial Site Recruiting
Hermitage, Tennessee, United States, 37076
United States, Texas
Clinical Trial Site Recruiting
Arlington, Texas, United States, 76012
Clinical Trial Site Recruiting
San Antonio, Texas, United States, 78215
Clinical Trial Site Recruiting
San Antonio, Texas, United States, 78229
Clinical Trial Site Recruiting
San Antonio, Texas, United States, 78230
Clinical Trial Site Recruiting
Temple, Texas, United States, 76508
Belgium
Clinical Trial Site Recruiting
Brussels, Belgium
Clinical Trial Site Recruiting
Edegem, Belgium
Bulgaria
Clinical Trial Site Recruiting
Pleven, Bulgaria
Clinical Trial Site Recruiting
Sofia, Bulgaria
Clinical Trial Site Recruiting
Stara Zagora, Bulgaria
Turkey
Clinical Trial Site Recruiting
Balçova, Turkey
Clinical Trial Site Recruiting
İzmir, Turkey
Clinical Trial Site Recruiting
Topkapı, Turkey
United Kingdom
Clinical Trial Site Recruiting
Edinburgh, United Kingdom
Clinical Trial Site Recruiting
London, United Kingdom
Clinical Trial Site Recruiting
Nottingham, United Kingdom
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
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Study Director: Medical Director Alnylam Pharmaceuticals
More Information
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Responsible Party: Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04565717    
Other Study ID Numbers: ALN-HSD-001
2020-000847-29 ( EudraCT Number )
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alnylam Pharmaceuticals:
Hepatobiliary disorders
Non-alcoholic fatty liver disease
NAFLD
Fatty liver
RNAi therapeutic
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases