Status:
RECRUITING
A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 b...
Eligibility Criteria
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, 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
- 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
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06945406
Start Date
May 16 2025
End Date
December 1 2026
Last Update
October 1 2025
Active Locations (1)
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1
Profil Institut für Stoffwechselforschung
Neuss, Germany, 41460