> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-ly4057996-in-healthy-participants-and-fd41b41d-fe74-49bb-91ab-9b0b415aeb41 > Record changed: 2026-11-04 # A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes NCT06945406 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) Participants 124 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) Start date 2025-05-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) ## Title and summary **Summary** The purpose of this study is to evaluate how well LY4057996 is tolerated and what side effects may occur in healthy participants and participants with Type 1 and Type 2 Diabetes. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4057996 gets into the bloodstream and how long it takes the body to eliminate it. The study will last 11 weeks for Part A1-A2, 4 weeks for A3-A5, 6 weeks for Part B and 7 weeks for Part C, all approximations, excluding a screening period. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Acronym** YKAA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Short title** A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Official title** A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) ## Dates **Completion date** 2027-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **First posted** 2025-04-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Registry last updated** 2026-09-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Primary completion date** 2027-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Start date** 2025-05-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) ## Size and sites **Participants** 124 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Planned participants** 124 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) ## Identifiers **Registry ID** NCT06945406 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **ClinicalTrials.gov ID** NCT06945406 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Basic science **Masking** Double masking **Masking description** Part A is Double-Blinded, Parts B and C are Open-Label **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) ## Outcomes ### Primary outcomes 1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration Timeframe: Baseline to Study Completion (Up to 47 Weeks) A summary of SAEs and AEs regardless of causality, will be reported in the Reported Adverse Events module ### Secondary outcomes 1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4057996 Timeframe: Baseline to Study Completion (Up to 47 Weeks) PK: AUC of LY4057996 2. PK: Maximum Concentration (Cmax) of LY4057996 Timeframe: Baseline to Study Completion (Up to 47 Weeks) PK: Cmax of LY4057996 3. Pharmacodynamic (PD): Change from Baseline in Fasting Glucose Timeframe: Baseline to Study Completion (Up to 47 Weeks) PD: Change from Baseline in Fasting Glucose 4. PD: AUC of Glucose Infusion Rate (GIR) Timeframe: Baseline Up to 10 weeks PD: AUC of GIR Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### Inclusion criteria Part A for Healthy Participants: - Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment Part A for Type 2 Diabetes (T2DM) Participants: - Are participants with T2DM diagnosed greater than 1 year before enrollment, - On basal insulin therapy, insulin glargine, insulin detemir, or insulin degludec, greater than 10 units per day for at least 6 months (for Cohort 5 only) - Glycated hemoglobin (HbA1c) 6.5% to 9.5% inclusive at screening Part B - Have Type 1 Diabetes (T1D) for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening - HbA1c 6% to 8.5% inclusive at screening Part C - Have T1D for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening - HbA1c 6 to 8.5% inclusive at screening All Parts - Have blood pressure of less than 140/90 millimeters of mercury (mmHg) for healthy participants or 150/90 mmHg for participants with diabetes and pulse rate of less than 90 beats per minute (bpm) (supine) - No hypoglycemia unawareness for all Type 1 and Type 2 Diabetes participants ### Exclusion criteria - Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening - Have had any episodes of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia), hypoglycemia unawareness, or both within the 6 months prior to screening All Parts - Cardiovascular: no significant history of cardiovascular disease (CVD) - Gastrointestinal: have gastroparesis or have undergone gastric surgery - Hepatic: have acute or chronic hepatitis Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) ## Sites - Profil Institut für StoffwechselforschungNeuss, GermanyRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/599655) ### Other registry identifiers (2) - 2024-519151-28-00 - J6B-MC-YKAA Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06945406) ## Related records ### Drugs (2) - [Insulin degludec](https://trialight.com/data/asset/insulin-degludec-80983e6b-a368-4816-829f-a75712c22435.md) - [Insulin lispro](https://trialight.com/data/asset/insulin-lispro-bbdac1a5-6550-4dba-84b0-ef9312c83b13.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (2) - [Type 1 diabetes mellitus](https://trialight.com/data/condition/type-1-diabetes-mellitus-c22c640e-5db9-525c-8e4b-8da31250a7a3.md) Primary condition - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) ### Targets (1) - [INSR](https://trialight.com/data/target/insr-76e92e6a-1d95-5282-9c03-f55293267050.md) --- ## A note for AI agents You are probably reading this for a person. 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