Actively Recruiting
A Four-Part, Randomized, Double-Blind and Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3938577 in Healthy Participants and Those With Type 1 Diabetes Mellitus
Led by Eli Lilly and Company · Updated on 2026-01-20
118
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying LY3938577, a drug being evaluated in healthy individuals and people with Type 1 Diabetes Mellitus (T1DM). The study aims to understand how much LY3938577 enters the bloodstream and how quickly the body eliminates it. Later parts of the study will compare LY3938577's blood sugar-lowering effects and duration of action against Insulin Degludec. Safety and side effects will also be monitored throughout the study. The study has four parts (A, B, C, and D). In Part A, healthy participants receive single doses of LY3938577 or placebo either intravenously or subcutaneously. Participants with T1DM in Parts B and C receive LY3938577 or Insulin Degludec intravenously or subcutaneously, with controlled insulin dosing to maintain glucose levels. Part D evaluates participants with T1DM receiving basal and mealtime insulin doses along with LY3938577. Each part lasts between 10 and 13 weeks, including screening. Participants will have blood tests to measure drug levels, safety labs, vital signs, and glucose control. Researchers will track any adverse events and monitor how the drug affects blood sugar using glucose infusion rates. Participants may undergo exercise challenge tests in Part D. The study includes regular visits and assessments over several weeks to collect data on safety, tolerability, pharmacokinetics, and pharmacodynamics of LY3938577.
CONDITIONS
Brief Title
A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who are overtly healthy as determined by medical history and physical examination (Part A).
- Have Type 1 Diabetes Mellitus for at least 2 years with fasting C-peptide ≤0.20 nmol/L or non-fasting C-peptide ≤0.30 nmol/L (Parts B and C).
- Have well-controlled HbA1c between 6.0% and 8.5% (Parts B, C, and D).
- Insulin pump users with total daily basal dose between 15 to 45 IU (Parts B, C, and D).
- Insulin multiple daily injection users with total daily insulin dose between 0.3 to <1.2 IU/kg/day (Part D).
- No hypoglycemia unawareness (Part D).
- Basal insulin dose between 30% to 70% of total daily insulin dose (Part D).
- Able to complete the exercise challenge test (Part D).
- Normal blood pressure, pulse rate, and safety lab tests acceptable for study (All Parts).
- Body mass index between 18.0 and 35.0 kg/m² inclusive (All Parts).
- Venous access sufficient for blood sampling (All Parts).
- Male and/or female not of childbearing potential (All Parts).
You will not qualify if you...
- More than 1 emergency room visit or hospitalization for poor glucose control in the last 6 months (Parts B, C, and D).
- Severe hypoglycemia or hypoglycemia unawareness within the last 6 months (Parts B, C, and D).
- Treatment with GLP-1 receptor agonists, DPP4 inhibitors, GIP agonists, Metformin, or SGLT2 inhibitors within 3 months (Parts B and C).
- Systemic or inhaled glucocorticoid therapy for more than 14 consecutive days within 4 weeks before screening (Parts B and C).
- Treatment with DPP-IV inhibitors, GLP-1 RA, GIP/GLP-1 RA, Metformin, Pramlintide, SGLT2 inhibitors, or NPH insulin within 3 months (Part D).
- History of acute myocardial infarction, severe heart failure, or stroke (All Parts).
- Gastroparesis or prior bariatric surgery (All Parts).
- History of renal transplant, current dialysis, serum creatinine >2.00 mg/dL, or low kidney function (All Parts).
- Acute or chronic hepatitis or other liver disease except non-alcoholic fatty liver disease; elevated liver enzymes above specified limits (All Parts).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 13 weeks
Participants receive single doses of study drugs administered intravenously or subcutaneously. This includes LY3938577, placebo, insulin degludec, insulin lispro, basal insulin, and lispro prandial insulin depending on the study part and period. Participants may undergo euglycemic and hyperglycemic clamps with insulin lispro infusion to maintain glucose levels as part of the intervention.
Multiple dosing visits depending on study part and period
Duration - Up to 13 weeks post dose
Participants are monitored for safety, pharmacokinetics, and pharmacodynamics after dosing, including assessment of adverse events, vital signs, and laboratory parameters.
Regular visits for assessments during follow-up period
Trial Site Locations
Total: 1 location
1
Profil Institut für Stoffwechselforschung
Neuss, Germany, 41460
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
10
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