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Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Completed · Phase 3 · NCT04677569

Conditions: Mycobacterium Infections, Nontuberculous

At a glance

Research payments reported, 2025
$1.8M
U.S. investigators named
69
Sites paid
68
Planned or actual enrollment
425

About the trial

Sponsor
Insmed Incorporated
Tested
ALIS (drug), Azithromycin (drug), Ethambutol (drug), ELC (matching placebo for ALIS) (drug)
Dates
Started 2021-04-01; completion 2026-01-15
Results posted
Not yet

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.

From ClinicalTrials.gov, last updated 2026-02-03. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Insmed, Inc. reported $1.8M in research payments for this study in 2025 (1,355 payments).

Products named: Arikayce

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.