Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT06052293
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2023-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1 Study to Assess Safety and Efficacy of ANG003
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-24', 'releaseDate': '2025-07-08'}], 'estimatedResultsFirstSubmitDate': '2025-07-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010188', 'term': 'Exocrine Pancreatic Insufficiency'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open-label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2023-08-09', 'studyFirstSubmitQcDate': '2023-09-18', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events (AE), Serious Adverse Events (SAE), and AEs Leading to Study Discontinuation', 'timeFrame': 'Assessed through study completion, up to 9 days (Day 1 thru Day 9).', 'description': 'AE, SAE, and AEs leading to study discontinuation measured by frequency and severity during study.'}, {'measure': 'Malabsorption Symptoms', 'timeFrame': 'Acute PAGI-SYM is based upon 7-day recall.', 'description': 'Severity of malabsorption symptoms (e.g., abdominal discomfort or pain, bloating, heartburn, regurgitation or reflux, retching, stomach fullness, and vomiting) by patient reported outcome scale (0=None; 1=Very Mild; 2=Mild; 3=Moderate; 4=Severe; 5=Very Severe). Measured by 20 questions contained in Acute Patient Assessment of Gastrointestinal Symptoms (Acute PAGI-SYM) questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Fat Absorption', 'timeFrame': 'Assessed through study completion, up to 9 days (Day 1 thru Day 9).', 'description': 'Measured by concentration and percent of plasma fatty acids.'}, {'measure': 'Protein Absorption', 'timeFrame': 'Assessed through study completion, up to 9 days (Day 1 thru Day 9).', 'description': 'Measured by changes in plasma concentration of amino acids.'}, {'measure': 'Carbohydrate Absorption', 'timeFrame': 'Assessed through study completion, up to 9 days (Day 1 thru Day 9).', 'description': 'Changes in glucose (mg/dL) as measured by continuous glucose monitoring.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystic Fibrosis'], 'conditions': ['Exocrine Pancreatic Insufficiency']}, 'descriptionModule': {'briefSummary': "Randomized, parallel, active-treatment Phase 1 study of a single dose of orally administered ANG003 with a test meal in adult subjects with cystic fibrosis-related exocrine pancreatic insufficiency. The study's overall objectives are to evaluate the safety, tolerability and effect of four dose levels of ANG003.", 'detailedDescription': 'The Phase 1 study was designed to compare a 24h Baseline Substrate Absorption Challenge Test (SACT) period with no enzymes to a 24h ANG003 SACT period with enzymes. Eligible subjects will be randomly assigned with equal allocation to one of four active dose levels of lipase, protease and amylase. Approximately 48 to 60 eligible subjects are planned to be enrolled in the study with 12 to 15 subjects assigned to each dose level from up to 21 investigational sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female subjects 18 years of age or older.\n2. Confirmed diagnosis of CF defined as: a) CF signs and symptoms AND b) Two CF-causing mutations on genetic testing or sweat chloride \\>60 mEq/L.\n3. Documented history of fecal elastase \\<100 µg/g stool.\n4. EPI clinically controlled with minimal clinical symptoms and on a stable dose of PERT for 90 days before screening as determined by the Investigator.\n5. Adequate nutritional status measured by body mass index ≥20kg/m2 for adult subjects.\n\nExclusion Criteria:\n\n1. Subjects with diabetes mellitus who are unable to refrain from short-acting and rapid-acting insulin on Days 1 and 5 for a daily total of 6 hours.\n2. Involuntary loss of ≥10% of usual body weight within last 6 months or involuntary loss of \\>5% of body weight within 1 month.\n3. Requires use of naso-gastric, J-tube, G-tube, and/or enteral feeding for the study duration.\n4. CF pulmonary exacerbation within 30 days prior to the Baseline SACT Period (Visit 2).\n5. Subjects who cannot discontinue omega-3 supplements \\>500 mg of DHA and EPA daily.\n6. Subjects unable to tolerate missing a dose of PERT.'}, 'identificationModule': {'nctId': 'NCT06052293', 'briefTitle': 'Phase 1 Study to Assess Safety and Efficacy of ANG003', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anagram Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1 Open-Label, Multicenter Study to Assess the Safety and Efficacy of ANG003 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'ANG003-22-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ANG003 Dose Level 1', 'description': 'Single administration starting dose contains lipase, protease and amylase.', 'interventionNames': ['Drug: ANG003']}, {'type': 'EXPERIMENTAL', 'label': 'ANG003 Dose Level 2', 'description': 'Single administration dose contains 2x lipase, 2x protease and 2x amylase starting dose.', 'interventionNames': ['Drug: ANG003']}, {'type': 'EXPERIMENTAL', 'label': 'ANG003 Dose Level 3', 'description': 'Single administration dose contains 4x lipase, 2x protease and 2x amylase starting dose.', 'interventionNames': ['Drug: ANG003']}, {'type': 'EXPERIMENTAL', 'label': 'ANG003 Dose Level 4', 'description': 'Single administration dose contains 6x lipase, 3x protease and 3x amylase starting dose.', 'interventionNames': ['Drug: ANG003']}], 'interventions': [{'name': 'ANG003', 'type': 'DRUG', 'otherNames': ['Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 4.'], 'description': 'To evaluate four possible combinations of lipase, protease and amylase.', 'armGroupLabels': ['ANG003 Dose Level 1', 'ANG003 Dose Level 2', 'ANG003 Dose Level 3', 'ANG003 Dose Level 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Memorial Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': "Norton Children's Research Institute affiliated with University of Louisville School of Medicine", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital,', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Harper University Hospital / Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'New York Medical College at Westchester Medical Center', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '44308', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Akron Childrens Hospital', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "UPMC Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Meghana Sathe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anagram Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-08', 'type': 'RELEASE'}, {'date': '2025-07-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Anagram Therapeutics, Inc.'}}}}