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A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes

NCT06945406 · Eli Lilly and Company
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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
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 124 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-05-16
Estimated completion: 2026-12
Last updated: 2026-03-11
Interventions
Drug: LY4057996 SCDrug: LY4057996 IVDrug: Placebo SCDrug: Placebo IVDrug: Degludec SCDrug: Lispro SCDrug: Degludec IVDrug: Pre-study basal insulin SC
Primary outcomes
  • 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 (Baseline to Study Completion (Up to 47 Weeks))
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (1)
Profil Institut für StoffwechselforschungRecruiting
Neuss, Germany
A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes · TrialPath