A multicentric, randomized, double blind, placebo controlled phase 2-study to evaluate the efficacy and safety of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (DAZALS).

This phase II study is sponsored by Corcept Therapeutics and will evaluate the safety (adverse events) and efficacy (clinical benefit) of dazicorulant. Dazucorilant is a glucocorticoid receptor antagonist that blocks the effects of cortisol. This study will investigate if dazucorilant can attenuate the neurotoxic effects of cortisol activity, and if ALS patients have clinical benefit by slowing functional decline.

The study medicine is a softgel capsule (4 capsules of 75mg in total) that are ingested in total every day around the same time, once a day with food and 240 ml of water. Participants have a 2 on 3 chance to receive the active study medicine. (1/3 will receive a 150mg dose, 1/3 will receive a 300mg dose, and 1/3 will receive a placebo.)

The trial will run about 1 year. Worldwide 198 patients will be included. More information about this trial can be found on the website www.clinicaltrials.org: https://clinicaltrials.gov/ct2/show/NCT05407324