Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-09 @ 2:54 PM
Study NCT ID:
NCT06808802
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2025-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Investigate the Effect of Retatrutide (LY3437943) on Metoprolol Pharmacokinetics in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729679', 'term': 'retatrutide'}, {'id': 'D008790', 'term': 'Metoprolol'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2025-01-31', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under Concentration From Time Zero to Infinity (AUC[0-∞]) of Metoprolol', 'timeFrame': 'Day 1 to Day 3', 'description': 'PK: AUC (0-∞) of Metoprolol'}, {'measure': 'Pharmacokinetics (PK): AUC (0-∞) of Metoprolol with Retatrutide', 'timeFrame': 'Day 9 to Day 11', 'description': 'PK: AUC (0-∞) of Metoprolol with Retatrutide'}, {'measure': 'PK: Maximum Concentration (Cmax) of Metoprolol', 'timeFrame': 'Day 1 to Day 3', 'description': 'PK: Cmax of Metoprolol'}, {'measure': 'PK: Cmax of Metoprolol with Retatrutide', 'timeFrame': 'Day 9 to Day 11', 'description': 'PK: Cmax of Metoprolol with Retatrutide'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with an Incidence of Treatment Emergent Adverse Events TEAEs (TEAEs)', 'timeFrame': 'Baseline to Day 44'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study J1I-MC-GZQE is to measure the effect of retatrutide on the pharmacokinetics (PK) of metoprolol in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and vital signs\n* Have a body mass index (BMI) within the range 22.0 to 35.0 kilogram per square meter (kg/m2) (inclusive) at screening\n\nExclusion Criteria:\n\n* Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form), or have glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5% (48 millimole/mole (mmol/mol)\n* Have a mean supine screening pulse rate of less than 45 or greater than 100 beats per minute (bpm) from 2 assessments. If a repeat measurement (mean of 2 assessments) shows values within the range of 45 to 100 bpm, the participant may be included in the trial\n* Have significant history of or current cardiovascular, respiratory, hepatic, renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data\n* Had any of the following cardiovascular conditions prior to screening: acute myocardial infarction, cerebrovascular accident, unstable angina, or hospitalization due to congestive heart failure'}, 'identificationModule': {'nctId': 'NCT06808802', 'briefTitle': 'To Investigate the Effect of Retatrutide (LY3437943) on Metoprolol Pharmacokinetics in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1, Open-label, Single-arm Study to Investigate the Effect of Retatrutide on Metoprolol Pharmacokinetics in Healthy Participants', 'orgStudyIdInfo': {'id': '27303'}, 'secondaryIdInfos': [{'id': 'J1I-MC-GZQE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retatrutide', 'description': 'In period 1, participants will be administered a singe oral dose of metoprolol followed by a 1-week washout before retatrutide subcutaneous (SC) injection is given in period 2, followed by a second dose of metoprolol.', 'interventionNames': ['Drug: Retatrutide', 'Drug: Metoprolol']}], 'interventions': [{'name': 'Retatrutide', 'type': 'DRUG', 'otherNames': ['LY3437943'], 'description': 'Administered subcutaneously (SC)', 'armGroupLabels': ['Retatrutide']}, {'name': 'Metoprolol', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Retatrutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138623', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Lilly Centre for Clinical Pharmacology', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}