Phase 3
Completed N=249
HEALEY ALS Platform Trial - Regimen G DNL343
Source: ClinicalTrials.gov NCT05842941 ↗Enrolled (actual)
249
Serious AEs
15.3%
Results posted
Jan 2026
Primary outcomePrimary: Disease Progression as Assessed by the ALSFRS-R-Slope — -0.88; -0.84 Percent change
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Progression as Assessed by the ALSFRS-R-Slope |
-0.88; -0.84 | — |
| PRIMARY Mortality Event Rate |
0.007; 0.007 | — |
| SECONDARY ALSFRS-R Total Score |
-5.759; -5.726 | 0.9562 |
| SECONDARY Combined Assessment of Function and Survival (CAFS) |
152.10; 162.39 | 0.4074 |
| SECONDARY Respiratory Function |
-12.259; -9.692 | 0.2856 |
| SECONDARY Upper Limb Muscle Strength |
-33.787; -38.573 | 0.2318 |
| SECONDARY Number of Participants With Death or Permanent Assisted Ventilation (PAV) |
8; 5 | 0.7628 |
| SECONDARY Number of Participants Who Experience Death |
6; 4 | 0.8662 |
| SECONDARY Disease Progression Biomarker |
0.074; -0.006 | 0.0304 sig |
Eligibility Criteria
Inclusion Criteria
- No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).
Exclusion Criteria
- The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).
- Diagnosis of epilepsy or seizure within 6 months of randomization
- Hypersensitivity to DNL343 or any of the excipients contained within the DNL343 drug product
- The concomitant use of prescription or over-the-counter (OTC) medications that are inducers of certain cytochrome P450 enzymes, substrates of certain cytochrome P450 enzymes, or substrates of certain drug transporters.
Data sourced from ClinicalTrials.gov (NCT05842941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.