At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 249 enrolled
Drug / intervention
DNL343 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
HEALEY ALS Platform Trial - Regimen G DNL343
In Brief
A Phase 3 clinical trial evaluating DNL343 and Matching Placebo for Amyotrophic Lateral Sclerosis. Completed, enrolled 249 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis
CountriesUnited States
CollaboratorsDenali Therapeutics Inc.
Timeline
Phase 3CompletedFinished
202420252026
First PostedMay 2023
Enrollment StartMay 2023
Primary CompletionOct 2024
TodayJul 2026
First PostedMay 6, 2023
Enrollment StartMay 24, 2023
Primary CompletionOct 29, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 3.2 years ago
Interventions
DNL343drug
DNL343 is administered orally once daily per day for 24 weeks.
Matching Placebodrug
Matching placebo is administered orally once daily per day for 24 weeks.