for people ages 18-80 (full criteria)
at San Diego, California and other locations
study started
completion around



This is a Phase 1b, multicenter, randomized, placebo-controlled, double-blind study of 28 days, followed by an 18-month open-label extension, designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL343 in participants with amyotrophic lateral sclerosis (ALS)

Official Title

A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study, Followed by an Open-Label Extension, to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis


This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).


Amyotrophic Lateral Sclerosis, ALS, Motor Neuron Disease, Sclerosis, DNL343


You can join if…

Open to people ages 18-80

  • Diagnosis of sporadic or familial ALS
  • ≤ 4 years since ALS symptom onset
  • Stable doses of approved ALS treatments (riluzole and/or edaravone) for at least 2 months prior to screening
  • Participants must be able to swallow the study intervention
  • Vital capacity >50% predicted at screening
  • Women must have been surgically sterilized, be postmenopausal, or for participants of childbearing potential, must not be pregnant, and both the participant and the male partner must use highly effective contraception
  • Men, and sex partner if a woman of childbearing potential, must use highly effective contraception

You CAN'T join if...

  • Any history of unstable or poorly controlled psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
  • Positive serum pregnancy test or currently lactating or breastfeeding
  • History of malignancy within 5 years
  • History of clinically significant neurologic disorders other than ALS


  • University of California at San Diego
    San Diego California 92093 United States
  • HonorHealth
    Scottsdale Arizona 85251 United States


in progress, not accepting new patients
Start Date
Completion Date
Denali Therapeutics Inc.
Phase 1 Amyotropic Lateral Sclerosis (ALS) Research Study
Study Type
Expecting 30 study participants
Last Updated