A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company
About this trial
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
Qualifiers
Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment
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
Disqualifiers
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
Cardiovascular: no significant history of cardiovascular disease (CVD)
Gastrointestinal: have gastroparesis or have undergone gastric surgery
Trial design
Treatments tested in this trial
- LY4057996 SC
- LY4057996 IV
- Placebo SC
- Placebo IV
- Degludec SC
- Lispro SC
- Degludec IV
- Pre-study basal insulin SC
Treatment groups
124 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov