Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT04641312
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2020-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of LY3457263 in Healthy Participants and Participants With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555680', 'term': 'dulaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01-01', 'completionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-10', 'studyFirstSubmitDate': '2020-11-20', 'studyFirstSubmitQcDate': '2020-11-20', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Baseline through Day 42', 'description': 'A summary of 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 From Time Zero to Infinity (AUC[0-inf]) of LY3457263', 'timeFrame': 'Day 1 through Day 42', 'description': 'PK: AUC\\[0-inf\\] of LY3457263'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 in healthy participants and participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study has two parts (part A and B). Each part will last up to 10 weeks and may include up to either 13 (part A) or 19 (part B) visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males that agree to use an effective method of contraception or agree to remain abstinent\n* Females that are not of childbearing potential due to postmenopausal status or due to surgical sterility\n* Part A only:\n\n * Are overtly healthy\n * Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²)\n* Part B only:\n\n * Have been diagnosed with Type 2 Diabetes (T2D) for at least 6 months prior to screening\n * Be treated for T2D with stable dose of metformin, a stable dose of a dipeptidyl peptidase-4 (DPP-4) inhibitor with or without metformin, or a stable dose of a glucagon-like peptide-1 (GLP-1) receptor agonist with or without metformin for at least 3 months prior to screening\n * BMI of 27 to 40 kg/m²\n\nExclusion Criteria:\n\n* Have undergone any form of bariatric surgery\n\n * Have used or intend to use medications that promote weight loss within 3 months prior to screening, for the duration of the study\n * Part A only:\n\n * Have fasting plasma glucose (PG) levels ≥7 millimoles per liter (mmol/L) (≥126 milligrams per deciliter (mg/dL)) at screening\n * Have Hemoglobin A1c (HbA1c) level ≥ 6.5% (48 millimoles per mole (mmol/mol)) at screening\n * Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>20% and 10%, above the upper limit of normal (ULN), respectively. Elevation of total bilirubin level is considered acceptable in case of Gilbert's disease (with a normal direct bilirubin)\n * Part B only:\n\n * Have Type 1 Diabetes or latent autoimmune diabetes in adults\n * Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening\n * Have known proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy\n * Present comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) unless they are well-controlled with stable medication\n * Have had an episode of severe hypoglycaemia within 6 months prior to screening, or have a history of hypoglycaemia unawareness or poor recognition of hypoglycaemia\n * Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase \\>2 × ULN at screening\n * Have a resting heart rate of \\<50 or \\>100 beats per minute\n * Have an estimated glomerular filtration rate (\\<60 milliliter/minute (mL/min)/1.73 m2, or a level of estimated glomerular filtration rate that would contraindicate the use of metformin per the label in the respective country\n * Have a screening calcitonin ≥20.0 picograms per milliliter (pg/mL)\n * Fasting serum triglyceride level of \\>500 mg/dL at screening\n * Have serum AST or ALT \\>3 × ULN or TBL \\>1.5 × ULN (except for participants diagnosed with Gilbert's syndrome)\n * Have taken any prescription medication that are specifically indicated for lowering serum triglycerides within the last 3 months\n * Have taken within the last 3 months any medications that interfere with absorption of dietary cholesterol or fats\n * Use of medications known to prolong the QT/QTc interval\n * Treated only with diet and exercise at study entry"}, 'identificationModule': {'nctId': 'NCT04641312', 'briefTitle': 'A Study of LY3457263 in Healthy Participants and Participants With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3457263 in Healthy Participants and in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '17261'}, 'secondaryIdInfos': [{'id': '2020-001828-34', 'type': 'EUDRACT_NUMBER'}, {'id': 'J1R-MC-GZFA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3457263 - Part A', 'description': 'Escalating single doses of LY3457263 administered subcutaneously (SC) to healthy participants', 'interventionNames': ['Drug: LY3457263']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Part A', 'description': 'Placebo administered SC to healthy participants', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3457263 - Part B', 'description': 'Escalating single doses of LY3457263 administered SC in combination with Dulaglutide administered SC to participants with type 2 diabetes', 'interventionNames': ['Drug: LY3457263', 'Drug: Dulaglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Part B', 'description': 'Placebo administered SC in combination with Dulaglutide administered SC to participants with type 2 diabetes', 'interventionNames': ['Drug: Dulaglutide', 'Drug: Placebo']}], 'interventions': [{'name': 'LY3457263', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY3457263 - Part A', 'LY3457263 - Part B']}, {'name': 'Dulaglutide', 'type': 'DRUG', 'otherNames': ['LY2189265'], 'description': 'Administered SC', 'armGroupLabels': ['LY3457263 - Part B', 'Placebo - Part B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo - Part A', 'Placebo - Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Profil Institut für Stoffwechselforschung', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}, {'zip': '55116', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Profil Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], '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'}}}}