A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)

Launched by ELI LILLY AND COMPANY · Feb 20, 2024

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ClinConnect Summary

This clinical trial is studying a new drug called LY3938577 to understand how it works in the body, especially for people with Type 1 Diabetes Mellitus (T1DM). The researchers want to find out how much of the drug gets into the bloodstream, how long it stays there, and how well it helps lower blood sugar compared to a commonly used insulin called Insulin Degludec. The study is divided into three parts: the first part involves healthy participants receiving a single dose of the drug or a placebo (a non-active substance), while the other two parts focus on participants with T1DM receiving either LY3938577 or Insulin Degludec through an intravenous (IV) infusion.

To be part of this trial, participants need to meet specific criteria. Healthy individuals must be generally well and pass a physical exam. Those with T1DM should have had the condition for at least two years, be well-controlled in their blood sugar levels, and use insulin pumps within certain dosage ranges. Participants can expect the study to last between about 5.5 to 13 weeks, depending on which part they're in. Throughout the study, researchers will monitor participants for any side effects and overall safety of the drug. If you or someone you know might be interested in participating, it's essential to discuss eligibility with a healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Part A -
• • • Participants who are overtly healthy as determined by medical history and physical examination.
• • Parts B and C -
• • Have Type 1 Diabetes Mellitus (T1DM) for at least 2 years with a fasting C-peptide level of 0.20 Nanomoles Per Liter (nmol/L) or less, or nonfasting C-peptide level of 0.30 nmol/L or less at screening.
• • Have well-controlled HbA1c between 6.0% to 8.5 percent (%).
• • Insulin pump users with a total daily basal dose between 15 to 45 International Unit (IU).
• • All Parts -
• • Have normal blood pressure, pulse rate and safety laboratory test results that are acceptable for the study.
• • Have body mass index (BMI) between 18.0 and 35.0 kilograms per meter squared (kg/m²), inclusive, at screening.
• • Have venous access sufficient to allow for blood sampling.
• • Male and/or female not of childbearing potential.
• Exclusion Criteria:
• • Parts B and C -
• • Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within the last 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 last 6 months prior to screening.
• • Have been treated with Glucagon-like Peptide-1 Receptor Agonists (GLP1-RA), Dipeptidyl Peptidase 4 (DPP4) inhibitor, Glucose-dependent Insulinotropic Polypeptide (GIP) agonists, Metformin, or Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors within the previous 3 months.
• • Have received systemic or inhaled glucocorticoid therapy (excluding topical, intraarticular, and intraocular preparations) for more than 14 consecutive days within 4 weeks before screening.
• • All Parts -
• • Have had any of the following cardiovascular conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke).
• • Have gastroparesis or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, Lap-Band®) prior to screening.
• • Have history of renal transplantation, currently receiving renal dialysis, have serum creatinine level of more than 2.00 milligrams per decilitre (mg/dL) or have an estimated glomerular filtration rate of less than 60.0 milliliters (mL) / minute /1.73 square meters.
• * Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease except non-alcoholic fatty liver disease (that is, participants with non-alcoholic fatty liver disease are eligible for participation), and/or have elevated liver enzyme measurements, as determined by the local laboratory at screening and as indicated:
• • Total bilirubin (TBL) \>2 × the Upper Limit of Normal (ULN) in the absence of Gilbert's syndrome, or
• • Alanine aminotransferase (ALT) /serum glutamic pyruvic transaminase (SGPT) \>2.5 × ULN, or
• • Aspartate aminotransferase (AST) /serum glutamic oxaloacetic transaminase (SGOT) \>2.5 × ULN.