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Trials |  |
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- ||| rapirosiran (ALN-HSD) / Regeneron
Enrollment open: NASHGEN-2: A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Non-Alcoholic Steatohepatitis (NASH) in Adult Participants at Increased Genetic Risk for This Condition (clinicaltrials.gov) - Apr 9, 2024
P2, N=120, Recruiting, Sponsor: Regeneron Pharmaceuticals
Active, not recruiting --> Recruiting
- ||| rapirosiran (ALN-HSD) / Regeneron
Trial termination: A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Mar 6, 2024
P1, N=6, Terminated, Sponsor: Alnylam Pharmaceuticals
Completed --> Terminated; Study ALN-HSD-001 was terminated due to business reasons and changes in the development strategy of the product. No safety issues were found.
- || rapirosiran (ALN-HSD) / Regeneron
Trial completion: A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Feb 15, 2024
P1, N=6, Completed, Sponsor: Alnylam Pharmaceuticals
No safety issues were found. Active, not recruiting --> Completed
- ||| rapirosiran (ALN-HSD) / Regeneron
Enrollment change, Trial completion date, Trial primary completion date: NASHGEN-2: A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Non-Alcoholic Steatohepatitis (NASH) in Adult Participants at Increased Genetic Risk for This Condition (clinicaltrials.gov) - Feb 15, 2024
P2, N=120, Active, not recruiting, Sponsor: Regeneron Pharmaceuticals
Active, not recruiting --> Completed N=300 --> 120 | Trial completion date: Dec 2026 --> Sep 2027 | Trial primary completion date: Dec 2026 --> Sep 2027
- ||| rapirosiran (ALN-HSD) / Regeneron
Enrollment closed: NASHGEN-2: A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Non-Alcoholic Steatohepatitis (NASH) in Adult Participants at Increased Genetic Risk for This Condition (clinicaltrials.gov) - Dec 11, 2023
P2, N=300, Active, not recruiting, Sponsor: Regeneron Pharmaceuticals
N=300 --> 120 | Trial completion date: Dec 2026 --> Sep 2027 | Trial primary completion date: Dec 2026 --> Sep 2027 Recruiting --> Active, not recruiting
- || rapirosiran (ALN-HSD) / Regeneron
Enrollment change, Trial completion date, Trial primary completion date: A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Nov 18, 2023
P1, N=6, Active, not recruiting, Sponsor: Alnylam Pharmaceuticals
Recruiting --> Active, not recruiting N=114 --> 6 | Trial completion date: May 2024 --> Dec 2023 | Trial primary completion date: May 2024 --> Dec 2023
- || rapirosiran (ALN-HSD) / Regeneron
Enrollment closed: A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Oct 23, 2023
P1, N=114, Active, not recruiting, Sponsor: Alnylam Pharmaceuticals
N=114 --> 6 | Trial completion date: May 2024 --> Dec 2023 | Trial primary completion date: May 2024 --> Dec 2023 Recruiting --> Active, not recruiting
- ||| rapirosiran (ALN-HSD) / Regeneron
Enrollment open, Trial completion date, Trial primary completion date: A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - May 9, 2023
P1, N=114, Recruiting, Sponsor: Alnylam Pharmaceuticals
Recruiting --> Active, not recruiting Active, not recruiting --> Recruiting | Trial completion date: Feb 2024 --> May 2024 | Trial primary completion date: Feb 2024 --> May 2024
- ALN-HSD / Regeneron, Alnylam
Phase 1 study of the RNA interference therapeutic ALN-HSD in healthy adults and patients with nonalcoholic steatohepatitis (Lehar 1-2) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_1505;
P1, P2
A Phase 2 study has been initiated to further investigate ALN-HSD in patients with NASH (NCT05519475). Co-funded by Alnylam Pharmaceuticals and Regeneron Pharmaceuticals, Inc.
- || rapirosiran (ALN-HSD) / Regeneron
Trial completion date, Trial primary completion date: A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Feb 16, 2023
P1, N=103, Active, not recruiting, Sponsor: Alnylam Pharmaceuticals
Co-funded by Alnylam Pharmaceuticals and Regeneron Pharmaceuticals, Inc. Trial completion date: Jan 2023 --> Feb 2024 | Trial primary completion date: Jan 2023 --> Feb 2024
- |||| rapirosiran (ALN-HSD) / Regeneron
Enrollment open: NASHGEN-2: A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Non-Alcoholic Steatohepatitis (NASH) in Adult Participants at Increased Genetic Risk for This Condition (clinicaltrials.gov) - Feb 16, 2023
P2, N=300, Recruiting, Sponsor: Regeneron Pharmaceuticals
Trial completion date: Jan 2023 --> Feb 2024 | Trial primary completion date: Jan 2023 --> Feb 2024 Not yet recruiting --> Recruiting
- ||| rapirosiran (ALN-HSD) / Regeneron
Trial completion date, Trial initiation date, Trial primary completion date: NASHGEN-2: A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Non-Alcoholic Steatohepatitis (NASH) in Adult Participants at Increased Genetic Risk for This Condition (clinicaltrials.gov) - Jan 19, 2023
P2, N=300, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
Not yet recruiting --> Recruiting Trial completion date: Aug 2026 --> Dec 2026 | Initiation date: Oct 2022 --> Jan 2023 | Trial primary completion date: Aug 2026 --> Dec 2026
- ||||| rapirosiran (ALN-HSD) / Regeneron
New P2 trial: NASHGEN-2: A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Non-Alcoholic Steatohepatitis (NASH) in Adult Participants at Increased Genetic Risk for This Condition (clinicaltrials.gov) - Aug 29, 2022
P2, N=300, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
- || rapirosiran (ALN-HSD) / Regeneron
Trial completion date, Trial primary completion date: A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Mar 14, 2022
P1, N=103, Active, not recruiting, Sponsor: Alnylam Pharmaceuticals
Trial completion date: Aug 2026 --> Dec 2026 | Initiation date: Oct 2022 --> Jan 2023 | Trial primary completion date: Aug 2026 --> Dec 2026 Trial completion date: Jun 2023 --> Jan 2023 | Trial primary completion date: May 2023 --> Jan 2023
- || rapirosiran (ALN-HSD) / Regeneron
Enrollment closed: A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Feb 15, 2022
P1, N=103, Active, not recruiting, Sponsor: Alnylam Pharmaceuticals
Trial completion date: Jun 2023 --> Jan 2023 | Trial primary completion date: May 2023 --> Jan 2023 Recruiting --> Active, not recruiting
- ||| rapirosiran (ALN-HSD) / Regeneron
Enrollment open: A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Oct 19, 2020
P1, N=128, Recruiting, Sponsor: Alnylam Pharmaceuticals
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- ||| rapirosiran (ALN-HSD) / Regeneron
New P1 trial: A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Sep 24, 2020
P1, N=128, Not yet recruiting, Sponsor: Alnylam Pharmaceuticals