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RNAi Therapeutics

ALN-HSD for Nonalcoholic Steatohepatitis

Phase 1
Waitlist Available
Research Sponsored by Alnylam Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a: up to 3.5 months; part b: up to 12.5 months
Awards & highlights

Study Summary

This trial is testing a new drug for safety and whether it can help people with NASH.

Who is the study for?
This trial is for adults with a healthy heart rhythm and BMI between 18-40 kg/m^2. Part A includes only healthy individuals, while Parts B and C are for patients with NASH, which is a type of liver disease caused by fat buildup in the liver. Participants must have had a recent biopsy showing NASH or have a clinical diagnosis based on specific criteria.Check my eligibility
What is being tested?
The study tests ALN-HSD, which could potentially treat NASH. Healthy participants will receive one dose (Part A), while those with NASH will get multiple doses (Parts B & C). The effects of ALN-HSD are compared to a placebo—a substance that has no therapeutic effect—to measure its safety and tolerability.See study design
What are the potential side effects?
While the side effects of ALN-HSD aren't detailed here, common ones in trials like this may include reactions at the injection site, fatigue, headache, gastrointestinal issues like nausea or diarrhea, and potential liver-related symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a: up to 3.5 months; part b: up to 12.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: up to 3.5 months; part b: up to 12.5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part C: Change from Baseline of Liver Hydroxysteroid 17β Dehydrogenase 13 (HSD17B13) Messenger Ribonucleic Acid (mRNA)
Parts A and B: Frequency of Adverse Events
Secondary outcome measures
Part A: Area Under the Plasma Concentration-time Curve (AUC) for ALN-HSD and Potential Metabolites
Part A: Fraction Excreted in Urine (fe) of ALN-HSD and Potential Metabolites
Part B: Change from Baseline of Liver HSD17B13 mRNA
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part C: ALN-HSDExperimental Treatment1 Intervention
Participants will be administered multiple doses of ALN-HSD.
Group II: Part B: ALN-HSDExperimental Treatment1 Intervention
Participants will be administered multiple doses of ALN-HSD.
Group III: Part A: ALN-HSDExperimental Treatment1 Intervention
Participants will be administered a single dose of ALN-HSD.
Group IV: Part B: PlaceboPlacebo Group1 Intervention
Participants will be administered multiple doses of ALN-HSD-matching placebo.
Group V: Part A: PlaceboPlacebo Group1 Intervention
Participants will be administered a single dose of ALN-HSD-matching placebo.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Alnylam PharmaceuticalsLead Sponsor
72 Previous Clinical Trials
14,812 Total Patients Enrolled
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,777 Previous Clinical Trials
8,063,474 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
500 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

ALN-HSD (RNAi Therapeutics) Clinical Trial Eligibility Overview. Trial Name: NCT04565717 — Phase 1
Non-alcoholic Fatty Liver Disease Research Study Groups: Part B: ALN-HSD, Part B: Placebo, Part C: ALN-HSD, Part A: ALN-HSD, Part A: Placebo
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: ALN-HSD Highlights & Side Effects. Trial Name: NCT04565717 — Phase 1
ALN-HSD (RNAi Therapeutics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04565717 — Phase 1
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04565717 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I be accepted to participate in this experiment?

"To be eligible for this medical trial, patients must have been diagnosed with NASH and fall between the age of 18-65. A total of 103 people will join in on the research."

Answered by AI

How many healthcare facilities are carrying out this experiment?

"As of now, 15 clinical sites are hosting this trial. These centres can be found in Inverness, San Antonio and Detroit as well as other cities throughout the United States. It is wise to choose a centre close by when considering enrollment so you do not have to travel too far for appointments."

Answered by AI

Is enrollment for this research study still taking place?

"According to clinicaltrials.gov, this trial is no longer recruiting new candidates. Initially posted on October 9th 2020 and last edited November 7th 2022, the study has closed its doors for enrollment; however, 237 other trials are still taking patients at present."

Answered by AI

Is there any danger posed by ALN-HSD to those undergoing treatment?

"We have assigned ALN-HSD a safety rating of 1 due to its status as a Phase 1 trial, indicating that the current evidence base is limited in terms of both efficacy and safety."

Answered by AI

Could individuals aged 65 and under be considered for this medical trial?

"This medical trial is restricted to individuals between the age of consent and 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
California
Maryland
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Clinical Trial Site
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I was around 220 pounds at time of my last Fibroscan. I joined Calibrate a weight loss program and lost 12-14 % of my body weight. I am currently doing a weight loss Clinical Trial with Curative through called Digbi health. While Calibrate's philosophy was to use pharmaceutical to reach a goal, Digbi Health's philosophy is to us food and improve the gut microbiome. The past 2 years I swim 5 days a week between 1/4 mile and 1 mile, weight train 3 days a week, pilates 2 days a week and walk to get at leat my 10,000 steps 6 days a week. I am stuck at around 185. But besides that, having lost between 12-14% of my body weight, I am curious as to the condition of my liver.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)
2020. "A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04565717.
~1 spots leftby Apr 2025
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