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HEALEY ALS Platform Trial - Regimen G DNL343

NCT05842941 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2026-01-28

Study results available
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Summary

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

Regimen G will evaluate the safety and efficacy of a single study drug, DNL343, in participants with ALS.

Conditions

Interventions

DRUG

DNL343

DNL343 is administered orally once daily per day for 24 weeks.

DRUG

Matching Placebo

Matching placebo is administered orally once daily per day for 24 weeks.

Sponsors & Collaborators

  • Denali Therapeutics Inc.

    collaborator INDUSTRY

  • Merit E. Cudkowicz, MD

    lead OTHER

Principal Investigators

  • Merit Cudkowicz, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-24
Primary Completion
2024-10-29
Completion
2024-10-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05842941 on ClinicalTrials.gov