protocolSection identificationModule nctId: NCT06280703, orgStudyIdInfo id: 18792, secondaryIdInfos id: J4P-MC-IYAB, type: OTHER, domain: Eli Lilly and Company, secondaryIdInfos id: U1111-1301-8386, type: OTHER, domain: Universal Trial Number, secondaryIdInfos id: 2023-510365-10-00, type: OTHER, domain: EU Trial Number, briefTitle: A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-02-17, completionDateStruct date: 2025-02-17, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it. At a later stage of this study (part B and C) the blood sugar lowering effect and the duration of action of LY3938577 will be evaluated compared to Insulin Degludec.The study will also evaluate the safety and tolerability of LY3938577 and information about any side effects experienced will be collected.The study will be conducted in three parts (A, B, and C). Healthy participants in part A will receive one single dose of LY3938577 or a placebo, whereas participants in Parts B and C with T1DM will receive single doses of either LY3938577 or Insulin Deglude given via intravenous (IV) infusion.The study will last up to approximately 5.5, 10 and 13 weeks for parts A, B, and C, respectively, including screening period., conditionsModule conditions: Healthy, conditions: Type 1 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Parallel (Part A) and Crossover design (Part B and Part C), primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: Double-Blind (Part A) and Open-Label (Part B and Part C), whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: LY3938577, interventions name: Placebo, interventions name: Insulin Degludec, interventions name: Insulin Lispro, outcomesModule primaryOutcomes measure: Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration., primaryOutcomes measure: Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration., primaryOutcomes measure: Part A: Number of Participants With Clinically Significant Changes in Vital Signs, primaryOutcomes measure: Part B: Number of Participants With Clinically Significant Changes in Vital Signs, primaryOutcomes measure: Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters, primaryOutcomes measure: Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters, primaryOutcomes measure: Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577, primaryOutcomes measure: Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577, primaryOutcomes measure: Part A: PK: Maximum Observed Concentration (Cmax) of LY3938577, primaryOutcomes measure: Part B: PK: Maximum Observed Concentration (Cmax) of LY3938577, primaryOutcomes measure: Part C: PK: Concentration of LY3938577, secondaryOutcomes measure: Part B: Pharmacodynamic (PD): Area under the glucose infusion rate curve (GIR AUC) of LY3938577, secondaryOutcomes measure: Part C: PD: Glucose infusion rate (GIR) of LY3938577, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Profil Institut für Stoffwechselforschung, city: Neuss, state: Nordrhein-Westfalen, zip: 41460, country: Germany, contacts role: CONTACT, phone: +49 (0) 2131 4018 450, contacts name: Oliver Klein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.19807, lon: 6.68504, hasResults: False