Recruiting
A Study 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…
ClinicalTrials.gov IDNCT06945406
PhasePHASE1
Enrollment124
SponsorEli Lilly and Company
Age18 Years and older
SexALL
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.
Interventions
- Drug: LY4057996 SC — Administered SC
- Drug: LY4057996 IV — Administered IV
- Drug: Placebo SC — Administered SC
- Drug: Placebo IV — Administered IV
- Drug: Degludec SC — Administered SC
- Drug: Lispro SC — Administered SC
- Drug: Degludec IV — Administered IV
- Drug: Pre-study basal insulin SC — Administered 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))
Eligibility information
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 locations
- Profil Institut für Stoffwechselforschung, Neuss, 41460 Germany
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-27.