DNL343 for Amyotrophic Lateral Sclerosis

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Denali Therapeutics Inc.

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

29 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called DNL343 in people with ALS. It aims to see if the drug is safe and how it affects the disease. Researchers will study how the drug moves through the body and its impact on ALS symptoms.

Research Team

Linus Sun, MD, PhD

Principal Investigator

Denali Therapeutics Inc.

Eligibility Criteria

Inclusion Criteria

Your lung function is good, and you can breathe well.

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

Exclusion Criteria

Positive serum pregnancy test or currently lactating or breastfeeding

You have a history of serious health problems that are not well managed or under control.

You have been diagnosed with cancer in the past 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either DNL343 or placebo for 28 days to evaluate safety, pharmacokinetics, and pharmacodynamics

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into continuation of treatment with DNL343 for 18 months

18 months

Treatment Details

Interventions

• DNL343
• Placebo

Participant Groups

Group I: DNL343 (Low Dose) Experimental Treatment 1 Intervention

Group II: DNL343 (High Dose) Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Denali Therapeutics Inc.

Lead Sponsor

Trials

24

Recruited

1,900+