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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT04677569

Public ClinicalTrials.gov record NCT04677569. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 10:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

Study identification

NCT ID
NCT04677569
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Insmed Incorporated
Industry
Enrollment
425 participants

Conditions and interventions

Interventions

  • ALIS Drug
  • Azithromycin Drug
  • Ethambutol Drug
  • ELC (matching placebo for ALIS) Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2021
Primary completion
Nov 20, 2025
Completion
Jan 14, 2026
Last update posted
Feb 2, 2026

2021 – 2026

United States locations

U.S. sites
90
U.S. states
28
U.S. cities
74
Facility City State ZIP Site status
USA008 Birmingham Alabama 35233-1711
USA062 Fresno California 93701
USA060 Los Angeles California 90033-5313
USA090 Newport Beach California 92663
USA058 Sacramento California 95817
USA048 San Diego California 92103
USA081 San Francisco California 94143
USA055 Santa Barbara California 93105
USA050 Stanford California 94305
USA001 Denver Colorado 80206
USA023 Washington D.C. District of Columbia 20007
USA080 Bradenton Florida 34209
USA028 Brandon Florida 33511-5719
USA003 Clearwater Florida 33765
USA043 Jacksonville Florida 32204
USA072 Jacksonville Florida 32207-8567
USA085 Jacksonville Florida 32209-6511
USA047 Jacksonville Florida 32224
USA042 Kissimmee Florida 34746
USA019 Leesburg Florida 34748
USA039 Naples Florida 34102-5444
USA096 Naples Florida 34102
USA097 Naples Florida 34102
USA046 New Port Richey Florida 34652
USA054 Sarasota Florida 34239-2913
USA084 Sebastian Florida 32958
USA026 Sebring Florida 33870
USA070 St. Petersburg Florida 33704-2733
USA014 St. Petersburg Florida 33707
USA067 Tampa Florida 33606
USA068 Tampa Florida 33614-7101
USA053 Weston Florida 33331
USA038 Atlanta Georgia 30342-2147
USA066 Augusta Georgia 30912
USA004 Lawrenceville Georgia 30046-3325
USA029 Rincon Georgia 31326
USA079 Coeur d'Alene Idaho 83814
USA031 Chicago Illinois 60611
USA073 Springfield Illinois 62702-4968
USA030 Springfield Illinois 62702
USA074 Iowa City Iowa 52242-1081
USA037 Kansas City Kansas 66160
USA002 New Orleans Louisiana 70112
USA017 Baltimore Maryland 21224-3057
USA099 Lexington Massachusetts 02421
USA077 Springfield Massachusetts 01107
USA013 Rochester Minnesota 55905
USA082 Columbia Missouri 65212-1000
USA061 St Louis Missouri 63110
USA045 Omaha Nebraska 68124
USA009 Omaha Nebraska 68198
USA069 Hillsborough New Jersey 08844
USA032 Toms River New Jersey 08755-8000
USA065 Bayside New York 11361
USA088 East Syracuse New York 13057
USA011 New York New York 10017
USA059 The Bronx New York 10461
USA076 Charlotte North Carolina 28204
USA035 Charlotte North Carolina 28273
USA033 Charlotte North Carolina 28277-8915
USA051 Durham North Carolina 27710-0001
USA034 Mooresville North Carolina 28117
USA007 Winston-Salem North Carolina 27103
USA075 Cincinnati Ohio 45242-4402
USA064 Cincinnati Ohio 45267
USA018 Cleveland Ohio 44195
USA063 Columbus Ohio 43210-1240
USA071 Portland Oregon 97213-2982
USA025 Portland Oregon 97239
USA015 DuBois Pennsylvania 15801
USA040 Philadelphia Pennsylvania 19104
USA093 Philadelphia Pennsylvania 19107
USA092 Providence Rhode Island 02906
USA044 Anderson South Carolina 29621
USA024 Charleston South Carolina 29414
USA020 Charleston South Carolina 29425
USA012 Rock Hill South Carolina 29732
USA022 Franklin Tennessee 37067
USA041 Hendersonville Tennessee 37075
USA078 Nashville Tennessee 37232
USA016 Dallas Texas 75246
USA100 Dallas Texas 75246
USA091 Denison Texas 75020
USA086 Houston Texas 77070-1190
USA021 McKinney Texas 75069-8085
USA006 San Antonio Texas 78258
USA089 Temple Texas 76508
USA052 Tyler Texas 75708
USA083 Charlottesville Virginia 22903
USA087 Madison Wisconsin 53792-0001

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 168 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04677569, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 2, 2026 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04677569 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →