Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT06567327
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2024-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Learn How the Study Medicine Danuglipron is Taken Up Into the Blood and If Danuglipron Changes How the Body Processes Other Study Medicines (Atorvastatin and Rosuvastatin) in Healthy Adults Who Are Overweight or Obese
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000731016', 'term': 'danuglipron'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron', 'timeFrame': 'Predose to 24 hours post danuglipron administration'}, {'measure': 'Steady-state maximum observed concentration (Cmax) for danuglipron', 'timeFrame': 'Predose to 24 hours post danuglipron administration'}, {'measure': 'Steady-state time to reach maximum observed concentration (Tmax) for danuglipron', 'timeFrame': 'Predose to 24 hours post danuglipron administration'}, {'measure': 'Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for atorvastatin', 'timeFrame': 'Predose to 72 hours post atorvastatin administration'}, {'measure': 'Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for atorvastatin (only if AUCinf is not reportable)', 'timeFrame': 'Predose to 72 hours post atorvastatin administration'}, {'measure': 'Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for rosuvastatin', 'timeFrame': 'Predose to 96 hours post rosuvastatin administration'}, {'measure': 'Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for rosuvastatin (only if AUCinf is not reportable)', 'timeFrame': 'Predose to 96 hours post rosuvastatin administration'}], 'secondaryOutcomes': [{'measure': 'Number of participants reporting Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From baseline up to 28-35 days post last dose taken'}, {'measure': 'Number of participants reporting clinically significant clinical laboratory abnormalities', 'timeFrame': 'From baseline up to 28-35 days post last dose taken'}, {'measure': 'Number of participants reporting clinically significant vital sign abnormalities', 'timeFrame': 'From baseline up to 28-35 days post last dose taken'}, {'measure': 'Change from baseline in body weight', 'timeFrame': 'From baseline up to 28-35 days post last dose taken'}, {'measure': 'Number of participants reporting clinically significant changes ECG abnormalities', 'timeFrame': 'From baseline up to 28-35 days post last dose taken'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overweight', 'Obesity', 'Danuglipron', 'GLP-1', 'Drug-drug interaction', 'Overtly healthy', 'Atorvastatin', 'Rosuvastatin'], 'conditions': ['Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C3421086', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese:\n\n* how the study medicine, danuglipron, is taken up into the blood\n* if the study medicine, danuglipron, changes how the body processes other study medicines (Atorvastatin and Rosuvastatin)\n* about the safety and tolerability of danuglipron\n\nThe study will take place in 4 Cohorts (groups). The total number of weeks of the study is about 23 (about 6 months) for Cohort 1 and 22 weeks (about 5.5 months) for Cohort 2, 21 weeks (about 5 months) for Cohort 3 and 20 weeks (about 5 months) for Cohort 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* 18 to \\< 65 years of age\n* Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight \\>50 kg (110 lb)\n\nKey Exclusion Criteria:\n\n* Evidence or history of any clinically significant medical conditions or laboratory abnormality\n* Any condition possibly affecting drug absorption\n* Known intolerance/hypersensitivity to a GLP-1R agonist and/or known hypersensitivity or contraindication to atorvastatin (Cohort 1 and 3 participants) or rosuvastatin (Cohort 2 and 4 participants)'}, 'identificationModule': {'nctId': 'NCT06567327', 'briefTitle': 'A Study to Learn How the Study Medicine Danuglipron is Taken Up Into the Blood and If Danuglipron Changes How the Body Processes Other Study Medicines (Atorvastatin and Rosuvastatin) in Healthy Adults Who Are Overweight or Obese', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Two-Part Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Multiple Dose Pharmacokinetics of Danuglipron Following Oral Administration and The Effects of Steady-State Danuglipron on the Pharmacokinetics of Single Oral Dose of Atorvastatin and Rosuvastatin in Otherwise Healthy Adult Participants With Overweight or Obesity', 'orgStudyIdInfo': {'id': 'C3421086'}, 'secondaryIdInfos': [{'id': 'NCT06567327', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin', 'interventionNames': ['Drug: Danuglipron', 'Drug: Atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin', 'interventionNames': ['Drug: Danuglipron', 'Drug: Rosuvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin', 'interventionNames': ['Drug: Danuglipron', 'Drug: Atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin', 'interventionNames': ['Drug: Danuglipron', 'Drug: Rosuvastatin']}], 'interventions': [{'name': 'Danuglipron', 'type': 'DRUG', 'otherNames': ['PF-06882961'], 'description': 'Danuglipron oral tablets', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'description': 'Atorvastatin oral tablets', 'armGroupLabels': ['Cohort 1', 'Cohort 3']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'description': 'Rosuvastatin oral tablets', 'armGroupLabels': ['Cohort 2', 'Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Qps - Mra, Llc.', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Qps-Mra, Llc', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}