Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGPhase 1INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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

Locations (1)

Profil Institut für Stoffwechselforschung
Neuss, Germany