Tests LY4057996 safety in healthy people and in people with diabetes
Tests LY4057996 in adults with type 1 or type 2 diabetes, and healthy adults.
Plain-language title generated from the registry record
Registry title: A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes
Key facts
- Where
- Neuss, GermanySee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT06945406, who can take part
Where in Germany
- PROFIL Institut fuer Stoffwechselforschung GmbHNeuss, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT06945406EU 2024-519151-28-00
- Record updated
- 29 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Gastrointestinal: have gastroparesis or have undergone gastric surgery; Cardiovascular: no significant history of cardiovascular disease (CVD); Hepatic: have acute or chronic hepatitis; 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.