What is LY3938577 studying for Type 1 Diabetes Mellitus?

LY3938577 is being studied to understand how it behaves in the body and its effects on blood sugar in people with Type 1 Diabetes Mellitus. The study compares LY3938577 to Insulin Degludec and evaluates safety and side effects. This research is sponsored by Eli Lilly and Company to explore new treatment options.

Who may be eligible for this Type 1 Diabetes Mellitus clinical trial?

Adults aged 18 to 64 with Type 1 Diabetes Mellitus for at least one year may be eligible. Participants should have well-controlled blood sugar levels and use insulin pumps or multiple daily injections. Healthy adults can also participate in early study parts. Please review eligibility criteria for more details.

Is there any cost to participate in this Type 1 Diabetes Mellitus clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel and related expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 1

Age: 18Years - 64Years

All Genders

Healthy Volunteers

ID06280703

Phase 1 Study of LY3938577 to Evaluate Safety, How It Works in the Body, and Blood Sugar Effects in Healthy Adults and Adults with Type 1 Diabetes

Led by Eli Lilly and Company · Updated on 2026-01-20

118

Participants Needed

Research Sites

N/A

Total Duration

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 LY3938577s 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

Age: 18Years - 64Years

All Genders

Healthy Volunteers

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).

Research Team

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Physicians interested in becoming principal investigators please contact

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Phase 1 Study of LY3938577 to Evaluate Safety, How It Works in the Body, and Blood Sugar Effects in Healthy Adults and Adults with Type 1 Diabetes

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria