Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-01-01 @ 6:36 PM
Study NCT ID:
NCT06703658
Status:
COMPLETED
Last Update Posted:
2025-03-21
First Post:
2024-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Japanese Participants and Participants With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2024-11-21', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PartA: Number of participants with adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'From screening (Day -28) to last follow up visit (Day 8)', 'description': 'To assess the safety and tolerability of AZD5004 following single oral doses in healthy participants.'}, {'measure': 'PartB: Number of participants with adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'From screening (Day -28) to last follow up visit (Day 119 )', 'description': 'To assess the safety and tolerability of AZD5004 following multiple oral ascending doses in participants with T2DM.'}], 'secondaryOutcomes': [{'measure': 'PartB: AUC0-4 for glucose, insulin and C-peptide for MMTT', 'timeFrame': 'From Day 1 to Day 105', 'description': 'To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: Absolute change from baseline to Day 105 in fasting plasma glucose', 'timeFrame': 'From Day 1 to Day 105', 'description': 'To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: % change from baseline to Day 105 in HOMA-IR', 'timeFrame': 'From Day 1 to Day 105', 'description': 'To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: The proportion of time in hyperglycaemia /hypoglycaemia over the last 7-day intervals at each dose level in CGM', 'timeFrame': 'From Day 1 to Day 106', 'description': 'To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: % change from baseline to Day 105 in body weight (kg)', 'timeFrame': 'From Day 1 to Day 105', 'description': 'To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: % change from baseline to Day 105 in waist circumference (cm)', 'timeFrame': 'From Day 1 to Day 105', 'description': 'To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartA: Area under the Plasma Concentration vs. Time Curve(AUC0-24)', 'timeFrame': 'From Day 1 to Day 6', 'description': 'To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD'}, {'measure': 'PartA: Area under the Plasma Concentration vs. Time Curve from Zero until the Time of the Last Concentration above the Limit of Quantification(AUC0-tlast)', 'timeFrame': 'From Day 1 to Day 6', 'description': 'To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD'}, {'measure': 'PartA: Area under the Plasma Concentration vs. Time Curve from Zero to Infinity(AUC0-inf)', 'timeFrame': 'From Day 1 to Day 6', 'description': 'To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD'}, {'measure': 'PartA: Maximum Observed Plasma Concentration(Cmax)', 'timeFrame': 'From Day 1 to Day 6', 'description': 'To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD'}, {'measure': 'PartA: Plasma Concentration at 24 Hours Post-Dose(C24h)', 'timeFrame': 'From Day 1 to Day 6', 'description': 'To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD'}, {'measure': 'PartA: Time of Occurrence of Maximum Plasma Concentration(tmax)', 'timeFrame': 'From Day 1 to Day 6', 'description': 'To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD'}, {'measure': 'PartA: Lag Time before Observation of Quantifiable Analyte Concentrations in Plasma(tlag)', 'timeFrame': 'From Day 1 to Day 6', 'description': 'To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD'}, {'measure': 'PartA: Half-Life(t1/2)', 'timeFrame': 'From Day 1 to Day 6', 'description': 'To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD'}, {'measure': 'PartA: Last measurable Non-Zero Concentration(Clast)', 'timeFrame': 'From Day 1 to Day 6', 'description': 'To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD'}, {'measure': 'PartA: Last measurable Non-Zero ConcentrationTime to Last Detectable Concentration(tlast)', 'timeFrame': 'From Day 1 to Day 6', 'description': 'To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD'}, {'measure': 'PartA: Apparent Oral Clearance(CL/F)', 'timeFrame': 'From Day 1 to Day 6', 'description': 'To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD'}, {'measure': 'PartA: Cumulative Urinary Excretion(Ae)', 'timeFrame': 'From Day 1 to Day 6', 'description': 'To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD'}, {'measure': 'PartA: Clearance(CLR)', 'timeFrame': 'From Day 1 to Day 6', 'description': 'To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD'}, {'measure': 'PartB: Area under the Plasma Concentration vs. Time Curve(AUC0-24)', 'timeFrame': 'Day 1', 'description': 'To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: Maximum Observed Plasma Concentration(Cmax)', 'timeFrame': 'Day 1, Day 49, Day 63, Day 77, Day91, Day105', 'description': 'To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: Plasma Concentration at 24 Hours Post-Dose(C24h)', 'timeFrame': 'Day 1', 'description': 'To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: Time of Occurrence of Maximum Plasma Concentration(tmax)', 'timeFrame': 'Day 1, Day 49, Day 63, Day 77, Day91, Day105', 'description': 'To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: Lag Time before Observation of Quantifiable Analyte Concentrations in Plasma(tlag)', 'timeFrame': 'Day 1', 'description': 'To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: Area under the Plasma Concentration vs. Time Curve over the Dosing Interval(AUC0-τ)', 'timeFrame': 'Day 49, Day 63, Day 77, Day 91, Day 105', 'description': 'To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: Observed Concentration at the End of the Dosing Interval(Cτ)', 'timeFrame': 'Day 49, Day 63, Day 77, Day 91, Day 105', 'description': 'To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: Half-Life(t1/2)', 'timeFrame': 'Day 49, Day 63, Day 77, Day 91, Day 105', 'description': 'To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: Apparent Oral Clearance(CL/F)', 'timeFrame': 'Day 49, Day 63, Day 77, Day 91, Day 105', 'description': 'To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: Cumulative Urinary Excretion(Ae)', 'timeFrame': 'Day 105', 'description': 'To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD'}, {'measure': 'PartB: Clearance(CLR)', 'timeFrame': 'Day 105', 'description': 'To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Type 2 Diabetes'], 'conditions': ['Healthy Participants', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This Phase I study will gather important information on the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5004 in both healthy Japanese participants and Japanese participants with T2DM.', 'detailedDescription': 'This is a placebo-controlled study to assess the safety, efficacy, tolerability, and PK of single and repeated dosing of AZD5004 compared with placebo.\n\nParticipants who are eligible according to the inclusion/exclusion criteria will be randomized to receive AZD5004 or matching placebo.\n\nThe study will comprise:\n\n1. A Screening Period of maximum 28 days.\n2. A Treatment Period of 1 day(Part A) or 105 days (Part B).\n3. A final Follow-up Visit approximately 7 days(Part A) or 14 days(Part B) after the last study intervention administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese men or women, and 18-65 years of age inclusive, at the time of signing the informed consent.\n\nInclusion Criteria for Part A:\n\n* HbA1c ≤ 6.0%.\n* Body weight ≥ 50.0 kg and BMI within the range 18.0-32.0 kg/m2.\n\nInclusion Criteria for Part B:\n\n* HbA1c ≥ 6.5% and ≤ 10.5%.\n* Not on any other diabetic medications.\n* Body weight ≥ 60.0 kg and BMI within the range 24.0-35.0 kg/m2\n\nExclusion Criteria:\n\n* Has a clinically relevant acute or chronic medical condition or disease.\n* History of acute pancreatitis and chronic pancreatitis, gallstones.\n* Abnormal renal function.\n* Known clinically significant gastric emptying abnormality\n* Significant hepatic disease.\n* Uncontrolled thyroid disease'}, 'identificationModule': {'nctId': 'NCT06703658', 'briefTitle': 'A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Japanese Participants and Participants With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Randomised, Single-blind, Placebo-controlled, Single and Repeated Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5004 in Healthy Japanese Participants and With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'D7260C00003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A-AZD5004', 'description': 'Participants will receive AZD5004 orally.', 'interventionNames': ['Drug: AZD5004(Part A)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A-Placebo', 'description': 'Participants will receive matching Placebo orally.', 'interventionNames': ['Drug: Placebo(Part A)']}, {'type': 'EXPERIMENTAL', 'label': 'Part B-AZD5004', 'description': 'Participants will receive AZD5004 orally.', 'interventionNames': ['Drug: AZD5004(Part B)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B-Placebo', 'description': 'Participants will receive matching Placebo orally.', 'interventionNames': ['Drug: Placebo(Part B)']}], 'interventions': [{'name': 'AZD5004(Part A)', 'type': 'DRUG', 'description': 'Single dose of AZD5004 oral on Day1', 'armGroupLabels': ['Part A-AZD5004']}, {'name': 'Placebo(Part A)', 'type': 'DRUG', 'description': 'Single dose of placebo oral on Day1', 'armGroupLabels': ['Part A-Placebo']}, {'name': 'AZD5004(Part B)', 'type': 'DRUG', 'description': 'AZD5004 will be administered as an oral tablet once daily.', 'armGroupLabels': ['Part B-AZD5004']}, {'name': 'Placebo(Part B)', 'type': 'DRUG', 'description': 'Placebo will be administered as an oral tablet once daily.', 'armGroupLabels': ['Part B-Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '532-0003', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}