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NCT04677569 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
A Phase 3 study, sponsored by Insmed Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 425
- Enrollment target
NCT04677569: Completed Phase 3 study, sponsored by Insmed Incorporated.
NCT04677569 is a Phase 3 study that has completed, run by Insmed Incorporated. The registered enrollment target is 425 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04677569, a Phase 3 study, has completed, sponsored by Insmed Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 425 participants
- Enrollment target
Study Summary
The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin \[AZI\] + ethambutol \[ETH\]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.
Interventions
- DRUG Azithromycin
- DRUG Ethambutol
- DRUG ALIS
- DRUG ELC (matching placebo for ALIS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 425 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2026-01-15 |
| Phase | Phase 3 |
What the finished NCT04677569 record still lists
NCT04677569 is an interventional study that assigns participants to a tested intervention. The registered 425 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 4 interventions - of which Azithromycin is the first listed.
NCT04677569 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04677569 about?
NCT04677569 is a clinical study titled "Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex". The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin \[AZI\] + ethambutol \[ETH\]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.
What is the current status of trial NCT04677569?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 425 participants. The study started on 2021-04-01. Estimated completion is 2026-01-15.
What interventions are being tested in trial NCT04677569?
The interventions under investigation include: Azithromycin (DRUG), Ethambutol (DRUG), ALIS (DRUG), ELC (matching placebo for ALIS) (DRUG).
Who is sponsoring clinical trial NCT04677569?
This trial is sponsored by Insmed Incorporated, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04677569's enrollment target sits among peer trials
425 883rd of 2000 higher than 1,117 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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