# Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment

> **NCT05021536** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Amylyx Pharmaceuticals Inc.** · enrollment: 664 (actual)

## Conditions studied

- Amyotrophic Lateral Sclerosis

## Interventions

- **OTHER:** Placebo
- **DRUG:** AMX0035

## Key facts

- **NCT ID:** NCT05021536
- **Lead sponsor:** Amylyx Pharmaceuticals Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2021-10-28
- **Primary completion:** 2024-01-19
- **Final completion:** 2026-01-01
- **Target enrollment:** 664 (ACTUAL)
- **Last updated:** 2024-08-14


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05021536

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05021536, "Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT05021536. Licensed CC0.

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