Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-04-21 @ 8:59 AM
Study NCT ID:
NCT05313802
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2022-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3502970 in Healthy Overweight and Obese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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': 'C000729680', 'term': 'orforglipron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10-01', 'completionDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2022-04-04', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Predose up to 42 days', 'description': 'A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970', 'timeFrame': 'Predose up to 29 days postdose', 'description': 'PK: AUC of LY3502970'}, {'measure': 'PK: Maximum Observed Concentration (Cmax) of LY3502970', 'timeFrame': 'Predose up to 29 days postdose', 'description': 'PK: Cmax of LY3502970'}, {'measure': 'PK: Time to Maximum Observed Concentration (Tmax) of LY3502970', 'timeFrame': 'Predose up to 29 days postdose', 'description': 'PK: Tmax of LY3502970'}, {'measure': 'Pharmacodynamics (PD): Change From Baseline in Body Weight', 'timeFrame': 'Predose through Day 28', 'description': 'PD: Change From Baseline in Body Weight'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Safety and Tolerability', 'LY3502970'], 'conditions': ['Healthy', 'Obese']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and tolerability of LY3502970 in healthy overweight and obese participants. The blood tests will be conducted to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in these participants. The study will last up to 42 days excluding the screening period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with stable body weight for at least one month prior to randomization.\n* Participants with body mass index (BMI) of greater than or equal to (≥) 27.0 kilograms per meter squared (kg/m²)\n* Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential\n\nExclusion Criteria:\n\n* Have known allergies to LY3502970 or other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs\n* Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders\n* Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %'}, 'identificationModule': {'nctId': 'NCT05313802', 'briefTitle': 'A Study of LY3502970 in Healthy Overweight and Obese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Multiple Dose Study in Healthy Overweight and Obese Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970', 'orgStudyIdInfo': {'id': '18453'}, 'secondaryIdInfos': [{'id': 'J2A-MC-GZGK', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3502970 (Dose Level 1)', 'description': 'LY3502970 administered orally.', 'interventionNames': ['Drug: LY3502970']}, {'type': 'EXPERIMENTAL', 'label': 'LY3502970 (Dose Level 2)', 'description': 'LY3502970 administered orally.', 'interventionNames': ['Drug: LY3502970']}, {'type': 'EXPERIMENTAL', 'label': 'LY3502970 (Dose Level 3)', 'description': 'LY3502970 administered orally.', 'interventionNames': ['Drug: LY3502970']}], 'interventions': [{'name': 'LY3502970', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY3502970 (Dose Level 1)', 'LY3502970 (Dose Level 2)', 'LY3502970 (Dose Level 3)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Qps-Mra, Llc', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'ICON Early Phase Services Lenexa Center', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'ICON Early Phase Services', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], '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'}}}}