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NCT06665165 · ClinicalTrials.gov registry record · Phase 1

AMX0114 in Adult Participants With Amyotrophic Lateral Sclerosis

A Phase 1 study of ALS, sponsored by Amylyx Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
48
Enrollment target
14
Study locations

NCT06665165 is a Phase 1 study of ALS that is actively recruiting participants, run by Amylyx Pharmaceuticals. The registered enrollment target is 48 participants, below the 1,034-participant average among 19 other ALS trials with a reported enrollment target (95% lower). The trial reports 14 study locations across 11 states.

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The verdict

NCT06665165, a Phase 1 study of ALS, is actively recruiting participants, sponsored by Amylyx Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
48 participants
Enrollment target
14
Study locations

Study Summary

This study is a placebo-controlled Phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the antisense oligonucleotide (ASO) AMX0114 in adult participants with amyotrophic lateral sclerosis (ALS).

Conditions Studied

ALS

Interventions

  • OTHER Placebo
  • DRUG AMX0114

Study Locations (14)

Florida

  • University of Florida - Gainesville
  • Mayo Clinic in Florida - Jacksonville
  • Orlando Regional Medical Center, Orlando Health Neuroscience Institute - Orlando

Ontario

  • McMaster University - Hamilton
  • London Health Sciences Centre - London

California

  • University of California, San Diego - La Jolla

District of Columbia

  • Georgetown University Hospital Pasquerilla Healthcare Center - Washington D.C.

Massachusetts

  • Massachusetts General Hospital, Healey & AMG Center for ALS - Boston

Minnesota

  • Mayo Clinic in Rochester - Rochester

Pennsylvania

  • Temple University of the Commonwealth System of Higher Education - Philadelphia

Tennessee

  • Alliance for Multispecialty Research, LLC - Knoxville

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2025-04-07
Est. Completion 2027-10
Phase Phase 1

Sponsor

Amylyx Pharmaceuticals

9 total trials

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What the Registry Record Tells You About NCT06665165

The ClinicalTrials.gov registry entry for NCT06665165 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,034-participant average among 19 other ALS trials with a reported enrollment target (95% lower). The listed sponsor is Amylyx Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with ALS appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06665165 reports 14 study locations spanning 11 distinct geographic areas - top geographies include Florida, Ontario, California.

Frequently Asked Questions

What is clinical trial NCT06665165 about?

NCT06665165 is a clinical study titled "AMX0114 in Adult Participants With Amyotrophic Lateral Sclerosis". This study is a placebo-controlled Phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the antisense oligonucleotide (ASO) AMX0114 in adult participants with amyotrophic lateral sclerosis (ALS).

What is the current status of trial NCT06665165?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2025-04-07. Estimated completion is 2027-10.

What conditions does trial NCT06665165 study?

This clinical trial studies the following conditions: ALS.

What interventions are being tested in trial NCT06665165?

The interventions under investigation include: Placebo (OTHER), AMX0114 (DRUG).

Who is sponsoring clinical trial NCT06665165?

This trial is sponsored by Amylyx Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06665165 being conducted?

This trial has 14 study locations across California, District of Columbia, Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.