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

Launched by ELI LILLY AND COMPANY · Apr 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called LY4057996 to see how well it is tolerated, and to learn about any side effects it may cause in both healthy individuals and those with Type 1 or Type 2 diabetes. The medication will be given either through an injection under the skin or through an IV (a small tube placed into a vein in the arm). Throughout the study, researchers will conduct blood tests to measure how much of the drug enters the bloodstream and how quickly the body gets rid of it. The trial will take place over several weeks, with different parts focusing on different groups of participants.

To be eligible for this study, healthy participants must be in good health based on medical evaluations. For those with Type 2 diabetes, they should have been diagnosed for at least a year and be on insulin treatment. Participants with Type 1 diabetes must also have been diagnosed for at least a year and meet specific blood test results. Overall, it’s important that all participants have stable health conditions and do not have a history of severe blood sugar issues. If you or a family member are considering participating, you can expect to receive close monitoring and support throughout the trial.

Gender

ALL

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, 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% 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) 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