[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627585":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":29,"centralContacts":46,"locations":52,"responsibleParty":436,"collaborators":29,"id":438,"slug":439,"hasResults":440,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":29,"eligibilityCriteria":444,"healthyVolunteers":440,"sex":445,"minAge":446,"maxAge":29,"enrollmentInfo":447,"targetDuration":29,"studyType":450,"phases":451,"briefSummary":453,"conditions":454,"keywords":457,"overallStatus":55,"whyStopped":29,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":468},{"fullName":5,"class":6},"Anagram Therapeutics, Inc.","INDUSTRY",[8,14,19,25,30],{"label":9,"type":10,"description":11,"interventionNames":12},"ANG003 Dose A","EXPERIMENTAL","All subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. If baseline CFA is \\>\u002F= 80%, the subject may be randomized to ANG003 Dose A for a 21-day acclimation and subsequent CFA analysis.",[13],"Drug: ANG003 Dose A",{"label":15,"type":10,"description":16,"interventionNames":17},"ANG003 Dose B","All subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. If baseline CFA is \\>\u002F= 80%, the subject may be randomized to ANG003 Dose B for a 21-day acclimation and subsequent CFA analysis.",[18],"Drug: ANG003 Dose B",{"label":20,"type":21,"description":22,"interventionNames":23},"Creon","ACTIVE_COMPARATOR","All subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. If baseline CFA is \\>\u002F= 80%, the subject may be randomized to Creon for an additional 21-days and subsequent CFA analysis.",[24],"Drug: Creon",{"label":26,"type":27,"description":28,"interventionNames":29},"Off Enzyme","NO_INTERVENTION","All subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. If baseline CFA is \\>\u002F= 80%, the subject may be randomized to the off enzyme arm. Subjects will receive Creon for an additional 21-day and the subsequent CFA analysis will be off enzyme. Total time off enzyme will be 4-7 days.",null,{"label":31,"type":32,"description":33,"interventionNames":34},"60% to \u003C80% CFA ANG003 Dose B","OTHER","All subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. Participants with a Period A CFA result of 60% to \\\u003C80% will be assigned to ANG003 Dose B.",[18],[36,40,43],{"type":37,"name":9,"description":38,"armGroupLabels":39,"otherNames":29},"DRUG","160,000 u\\* lipase, 105,000 u\\* protease, and 11,600 u\\* amylase per dose (\\*units are comparable to United States Pharmacopeiea \\[USP\\])",[9],{"type":37,"name":15,"description":41,"armGroupLabels":42,"otherNames":29},"240,000 u\\* lipase, 105,000 u\\* protease, and 11,600 u\\* amylase per dose (\\*units are comparable to United States Pharmacopeiea \\[USP\\])",[31,15],{"type":37,"name":20,"description":44,"armGroupLabels":45,"otherNames":29},"The commercially available pPERT Creon will be the active comparator in the study. Subjects will be instructed to take Creon according to the package insert and PI direction.",[20],[47],{"name":48,"role":49,"phone":50,"phoneExt":29,"email":51},"Evan Bailey, MD","CONTACT","617-466-3111","medical@anagramtx.com",[53,72,87,102,117,131,146,161,176,191,206,221,232,247,261,276,291,306,320,334,348,363,377,392,407,422],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Long Beach Memorial Medical Center","RECRUITING","Long Beach","California","90806","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-118.18923,33.76696,{"lat":65,"lon":64},[68],{"name":69,"role":49,"phone":70,"phoneExt":29,"email":71},"Angelica Rodriguez","562-706-1245","ARodriguez9@memorialcare.org",{"facility":73,"status":74,"city":75,"state":57,"zip":76,"country":59,"countryCode":60,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Center for Cystic Fibrosis at Keck Medical Center of USC","NOT_YET_RECRUITING","Los Angeles","90033",{"type":62,"coordinates":78},[79,80],-118.24368,34.05223,{"lat":80,"lon":79},[83],{"name":84,"role":49,"phone":85,"phoneExt":29,"email":86},"Lynn Fukushima","323-442-8522","lynn.fukushima@med.usc.edu",{"facility":88,"status":74,"city":89,"state":90,"zip":91,"country":59,"countryCode":60,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"National Jewish Health","Denver","Colorado","80206",{"type":62,"coordinates":93},[94,95],-104.9847,39.73915,{"lat":95,"lon":94},[98],{"name":99,"role":49,"phone":100,"phoneExt":29,"email":101},"Alix Wilson","303-270-2517","wilsona@njhealth.org",{"facility":103,"status":74,"city":104,"state":105,"zip":106,"country":59,"countryCode":60,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"University of Florida","Gainesville","Florida","32610",{"type":62,"coordinates":108},[109,110],-82.32483,29.65163,{"lat":110,"lon":109},[113],{"name":114,"role":49,"phone":115,"phoneExt":29,"email":116},"Alexa Smith","352-273-8380","alexa.howell@ufl.edu",{"facility":118,"status":74,"city":119,"state":105,"zip":120,"country":59,"countryCode":60,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Central Florida Pulmonary Group","Orlando","32803",{"type":62,"coordinates":122},[123,124],-81.37924,28.53834,{"lat":124,"lon":123},[127],{"name":128,"role":49,"phone":129,"phoneExt":29,"email":130},"Desiree Serr","407-303-7192","desiree.serr1@adventhealth.com",{"facility":132,"status":55,"city":133,"state":134,"zip":135,"country":59,"countryCode":60,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"The Cystic Fibrosis Institute","Glenview","Illinois","60025",{"type":62,"coordinates":137},[138,139],-87.78784,42.06975,{"lat":139,"lon":138},[142],{"name":143,"role":49,"phone":144,"phoneExt":29,"email":145},"Steven R Boas, MD","847-998-3434","sboas@wecare4lungs.com",{"facility":147,"status":74,"city":148,"state":149,"zip":150,"country":59,"countryCode":60,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"University of Iowa","Iowa City","Iowa","52242",{"type":62,"coordinates":152},[153,154],-91.53017,41.66113,{"lat":154,"lon":153},[157],{"name":158,"role":49,"phone":159,"phoneExt":29,"email":160},"Mary Teresi","319-384-7546","mary-teresi@uiowa.edu",{"facility":162,"status":74,"city":163,"state":164,"zip":165,"country":59,"countryCode":60,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"University of Kansas Medical Center","Kansas City","Kansas","66160",{"type":62,"coordinates":167},[168,169],-94.62746,39.11417,{"lat":169,"lon":168},[172],{"name":173,"role":49,"phone":174,"phoneExt":29,"email":175},"Lawrence Scott","913-588-4020","lscott2@kumc.edu",{"facility":177,"status":74,"city":178,"state":179,"zip":180,"country":59,"countryCode":60,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"University of Kentucky","Lexington","Kentucky","40506",{"type":62,"coordinates":182},[183,184],-84.47772,37.98869,{"lat":184,"lon":183},[187],{"name":188,"role":49,"phone":189,"phoneExt":29,"email":190},"Chase Whitaker","859-218-4810","chase.whitaker@uky.edu",{"facility":192,"status":74,"city":193,"state":194,"zip":195,"country":59,"countryCode":60,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"MaineHealth Pediatric Specialty Care","Portland","Maine","04102",{"type":62,"coordinates":197},[198,199],-70.2589,43.65737,{"lat":199,"lon":198},[202],{"name":203,"role":49,"phone":204,"phoneExt":29,"email":205},"Rebecca Edwards","207-662-6712","rebecca.edwards@mainehealth.org",{"facility":207,"status":74,"city":208,"state":209,"zip":210,"country":59,"countryCode":60,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":62,"coordinates":212},[213,214],-71.05977,42.35843,{"lat":214,"lon":213},[217],{"name":218,"role":49,"phone":219,"phoneExt":29,"email":220},"Margot Hardcastle","617-726-3719","mhardcastle@mgh.harvard.edu",{"facility":222,"status":74,"city":208,"state":209,"zip":223,"country":59,"countryCode":60,"cosmosGeoPoint":224,"geoPoint":226,"contacts":227},"Boston Children's Hospita","02115",{"type":62,"coordinates":225},[213,214],{"lat":214,"lon":213},[228],{"name":229,"role":49,"phone":230,"phoneExt":29,"email":231},"Robert Fowler","617-355-1834","Robert.fowler@childrens.harvard.edu",{"facility":233,"status":55,"city":234,"state":235,"zip":236,"country":59,"countryCode":60,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"University of Michigan, Michigan Medicine","Ann Arbor","Michigan","48109",{"type":62,"coordinates":238},[239,240],-83.74088,42.27756,{"lat":240,"lon":239},[243],{"name":244,"role":49,"phone":245,"phoneExt":29,"email":246},"Dawn Kruse","734-615-3266","dmkruse@med.umich.edu",{"facility":248,"status":74,"city":249,"state":235,"zip":250,"country":59,"countryCode":60,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Wayne State University Harper University Hospital","Detroit","48201",{"type":62,"coordinates":252},[253,254],-83.04575,42.33143,{"lat":254,"lon":253},[257],{"name":258,"role":49,"phone":259,"phoneExt":29,"email":260},"Debra Driscoll","313-745-2221","ddriscol@med.wayne.edu",{"facility":262,"status":74,"city":263,"state":264,"zip":265,"country":59,"countryCode":60,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Rutgers - Robert Wood Johnson Medical School","New Brunswick","New Jersey","08903",{"type":62,"coordinates":267},[268,269],-74.45182,40.48622,{"lat":269,"lon":268},[272],{"name":273,"role":49,"phone":274,"phoneExt":29,"email":275},"Sheila Redding","732-235-7840","sr1238@rwjms.rutgers.edu",{"facility":277,"status":74,"city":278,"state":279,"zip":280,"country":59,"countryCode":60,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"New York Medical College at Westchester Medical Center","Valhalla","New York","10595",{"type":62,"coordinates":282},[283,284],-73.77513,41.07482,{"lat":284,"lon":283},[287],{"name":288,"role":49,"phone":289,"phoneExt":29,"email":290},"Zachary Messer","914-594-2352","Zachary_Messer@nymc.edu",{"facility":292,"status":74,"city":293,"state":294,"zip":295,"country":59,"countryCode":60,"cosmosGeoPoint":296,"geoPoint":300,"contacts":301},"Children's Hospital Medical Center of Akron","Akron","Ohio","44308",{"type":62,"coordinates":297},[298,299],-81.51901,41.08144,{"lat":299,"lon":298},[302],{"name":303,"role":49,"phone":304,"phoneExt":29,"email":305},"Michelle Parrish","330-543-3089","MParrish@akronchildrens.org",{"facility":307,"status":74,"city":308,"state":294,"zip":309,"country":59,"countryCode":60,"cosmosGeoPoint":310,"geoPoint":314,"contacts":315},"Rainbow Babies and Children's Hospital\u002FUniversity Hospitals Cleveland Medical Center","Cleveland","44106",{"type":62,"coordinates":311},[312,313],-81.69541,41.4995,{"lat":313,"lon":312},[316],{"name":317,"role":49,"phone":318,"phoneExt":29,"email":319},"Primary RC & Participant Contact General Contact","216-844-3911","RainbowCFResearch@UHhospitals.org",{"facility":321,"status":74,"city":322,"state":294,"zip":323,"country":59,"countryCode":60,"cosmosGeoPoint":324,"geoPoint":328,"contacts":329},"Nationwide Children's Hospital, Columbus","Columbus","43205",{"type":62,"coordinates":325},[326,327],-82.99879,39.96118,{"lat":327,"lon":326},[330],{"name":331,"role":49,"phone":332,"phoneExt":29,"email":333},"Diana Gilmore","614-722-4752","diana.gilmore@nationwidechildrens.org",{"facility":335,"status":74,"city":336,"state":294,"zip":337,"country":59,"countryCode":60,"cosmosGeoPoint":338,"geoPoint":342,"contacts":343},"Toledo Children's Hospital","Toledo","43606",{"type":62,"coordinates":339},[340,341],-83.55521,41.66394,{"lat":341,"lon":340},[344],{"name":345,"role":49,"phone":346,"phoneExt":29,"email":347},"Kelly Hoot","419-291-4630","kelly.hoot@promedica.org",{"facility":349,"status":55,"city":350,"state":351,"zip":352,"country":59,"countryCode":60,"cosmosGeoPoint":353,"geoPoint":357,"contacts":358},"Hershey Medical Center Pennsylvania State University","Hershey","Pennsylvania","17033",{"type":62,"coordinates":354},[355,356],-76.65025,40.28592,{"lat":356,"lon":355},[359],{"name":360,"role":49,"phone":361,"phoneExt":29,"email":362},"Diane Kitch","717-531-5646","dkitch@pennstatehealth.psu.edu",{"facility":364,"status":74,"city":365,"state":351,"zip":366,"country":59,"countryCode":60,"cosmosGeoPoint":367,"geoPoint":371,"contacts":372},"University of Pittsburgh Medical Center","Pittsburgh","15224",{"type":62,"coordinates":368},[369,370],-79.99589,40.44062,{"lat":370,"lon":369},[373],{"name":374,"role":49,"phone":375,"phoneExt":29,"email":376},"Adrienne DeRicco","412-692-8069","adrienne.dericco2@upmc.edu",{"facility":378,"status":74,"city":379,"state":380,"zip":381,"country":59,"countryCode":60,"cosmosGeoPoint":382,"geoPoint":386,"contacts":387},"University of Texas Southwestern \u002F Children's Health","Dallas","Texas","75207",{"type":62,"coordinates":383},[384,385],-96.80667,32.78306,{"lat":385,"lon":384},[388],{"name":389,"role":49,"phone":390,"phoneExt":29,"email":391},"Keianna Brown","214-456-5489","Keianna.brown@utsouthwestern.edu",{"facility":393,"status":74,"city":394,"state":395,"zip":396,"country":59,"countryCode":60,"cosmosGeoPoint":397,"geoPoint":401,"contacts":402},"Adult Cystic Fibrosis Center at the University of Utah","Salt Lake City","Utah","84112",{"type":62,"coordinates":398},[399,400],-111.89105,40.76078,{"lat":400,"lon":399},[403],{"name":404,"role":49,"phone":405,"phoneExt":29,"email":406},"Kristyn Packer","801-520-5106","kristyn.packer@hsc.utah.edu",{"facility":408,"status":55,"city":409,"state":410,"zip":411,"country":59,"countryCode":60,"cosmosGeoPoint":412,"geoPoint":416,"contacts":417},"University of Wisconsin","Madison","Wisconsin","53792",{"type":62,"coordinates":413},[414,415],-89.40123,43.07305,{"lat":415,"lon":414},[418],{"name":419,"role":49,"phone":420,"phoneExt":29,"email":421},"Melanie Nelson","608-265-4617","mnelson@pediatrics.wisc.edu",{"facility":423,"status":74,"city":424,"state":410,"zip":425,"country":59,"countryCode":60,"cosmosGeoPoint":426,"geoPoint":430,"contacts":431},"Froedtert & Medical College of Wisconsin","Milwaukee","53226",{"type":62,"coordinates":427},[428,429],-87.90647,43.0389,{"lat":429,"lon":428},[432],{"name":433,"role":49,"phone":434,"phoneExt":29,"email":435},"Erin Hubertz","414-955-7019","ehubertz@mcw.edu",{"type":437,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100627585","phase-2-phase-2-study-to-assess-the-safety-and-efficacy-of-ang003-100627585",false,"NCT07450547","Phase 2 Study to Assess the Safety and Efficacy of ANG003","A Phase 2, Multicenter, Randomized, Active-controlled Study to Assess the Safety and Efficacy of ANG003 at Two Different Dose Levels in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis","Inclusion Criteria:\n\n1. Male and female subjects aged ≥12 years from the date of informed consent in the US and aged ≥18 years in the EU\n2. Confirmed and documented diagnosis of CF\n3. Diagnosed with severe EPI as defined by a fecal elastase ≤50 μg\u002Fg stool measured at Screening by a central laboratory.\n4. Subject has controlled EPI and taking a stable dose of pancreatic enzyme replacement therapy (PERT) for 90 days prior to Screening.\n5. Adequate nutritional status measured by body mass index (BMI) defined by:\n\n   1. BMI ≥25th percentile for children aged 12-17 years\n   2. BMI ≥18.5 kg\u002Fm2 for ≥18 years of age\n\nExclusion Criteria:\n\n1. History of fibrosing colonopathy or recurring distal intestinal obstructive syndrome within 6 months of Screening.\n2. History of lung or liver transplant, listing for organ transplant or significant bowel resection within the last 6 months. Subjects with a history of resection that does not result in short bowel syndrome are eligible.\n3. Known hypersensitivity or other severe reaction to any ingredient of the investigational product (IP), Creon, or the stool marker (FD\\&C Blue #2).\n4. Any chronic diarrheal illness unrelated to pancreatic insufficiency, actively being treated for small intestinal bacterial overgrowth, requiring use of naso-gastric, J-tube, G-tube, and\u002For enteral feeding for the study duration, Clostridioides difficile infection within 6 months prior to Screening, or severe constipation defined as \\\u003C1 bowel movement\u002Fweek.","ALL","12 Years",{"count":448,"type":449},113,"ESTIMATED","INTERVENTIONAL",[452],"PHASE2","In this study, ANG003, a pancreatic enzyme replacement therapy (PERT; commonly called \"enzymes\"), is being investigated as a potential treatment for exocrine pancreatic insufficiency (EPI). People with EPI due to Cystic Fibrosis (CF) may be eligible to participate in this study. The primary objective of this study is to evaluate the safety of ANG003 and see if it works as well compared to Creon, an approved PERT.",[455,456],"Exocrine Pancreatic Insufficiency (EPI)","Cystic Fibrosis (CF)",[456,458],"EPI","2026-07-01",{"date":461,"type":462},"2026-07-02","ACTUAL",{"date":464,"type":462},"2026-04-24",{"date":466,"type":449},"2027-07",{"name":5,"class":6},26]