Actively Recruiting
A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)
Led by Eli Lilly and Company · Updated on 2026-01-20
118
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it. At a later stage of this study (part B and C) the blood sugar lowering effect and the duration of action of LY3938577 will be evaluated compared to Insulin Degludec. The study will also evaluate the safety and tolerability of LY3938577 and information about any side effects experienced will be collected. The study will be conducted in four parts (A, B, C, and D). Healthy participants in Part A Period 1 will receive a single dose of LY3938577 or a placebo given via intravenous (IV) infusion. In Part A Period 2, participants will receive a single subcutaneous (SC) dose of either LY3938577 or placebo. Participants in Part B with Type 1 Diabetes Mellitus (T1DM) will receive single doses of either LY3938577 or Insulin Degludec given via IV infusion. Participants in Part C with Type 1 Diabetes Mellitus (T1DM) will receive two doses of either LY3938577 or Insulin Degludec administered SC. Participants in Part D with Type 1 Diabetes Mellitus (T1DM) will be evaluated in 2 periods, with Period 1 administered pre-study basal insulin and lispro mealtime insulin to establish insulin needs, and Period 2 administered lispro mealtime insulin and daily doses of LY3938577. The study will last up to approximately 11 weeks for Part A, 10 weeks for Part B, 13 weeks for Part C, and 10 weeks for Part D , including screening period.
CONDITIONS
Official 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...
- For Part A, participants must be healthy based on medical history and physical exam.
- For Parts B and C, participants must have Type 1 Diabetes Mellitus for at least 2 years with low fasting or nonfasting C-peptide levels.
- For Parts B and C, HbA1c must be between 6.0% and 8.5%.
- For Parts B and C, insulin pump users must have a total daily basal dose between 15 to 45 IU.
- For Part D, participants must have Type 1 Diabetes Mellitus for at least 1 year with low fasting or nonfasting C-peptide levels.
- For Part D, HbA1c must be between 6% and 8.5% inclusive.
- For Part D, insulin pump users must have a total daily basal dose between 15 to 45 IU.
- For Part D, multiple daily injection insulin users must have a total daily insulin dose between 0.3 to less than 1.2 IU/kg/day.
- For Part D, participants must have no hypoglycemia unawareness.
- For Part D, basal insulin dose must be 30% to 70% of total daily insulin dose.
- For Part D, participants must be able to complete the exercise challenge test.
- For all parts, participants must have normal blood pressure, pulse, and acceptable safety lab results.
- For all parts, BMI must be between 18.0 and 35.0 kg/m2 inclusive.
- For all parts, participants must have sufficient venous access for blood sampling.
- For all parts, participants must be male or female not of childbearing potential.
You will not qualify if you...
- For Parts B, C, and D, participants with more than one emergency room visit or hospitalization due to poor glucose control in the last 6 months are excluded.
- For Parts B, C, and D, participants with severe hypoglycemia or hypoglycemia unawareness in the last 6 months are excluded.
- For Parts B and C, participants treated with GLP-1 RA, DPP4 inhibitors, GIP agonists, Metformin, or SGLT2 inhibitors within 3 months are excluded.
- For Parts B and C, participants who received systemic or inhaled glucocorticoids for more than 14 days within 4 weeks before screening are excluded.
- For Part D, participants treated with DPP-IV inhibitors, GLP-1 RA, GIP/GLP-1 RA, Metformin, Pramlintide, SGLT2 inhibitors, or NPH insulin within 3 months are excluded.
- For all parts, participants with acute myocardial infarction, severe heart failure, or stroke are excluded.
- For all parts, participants with gastroparesis or who had gastric bypass or restrictive bariatric surgery before screening are excluded.
- For all parts, participants with history of renal transplant, receiving dialysis, serum creatinine over 2.00 mg/dL, or low kidney function are excluded.
- For all parts, participants with acute or chronic hepatitis, liver disease signs, or high liver enzyme levels beyond specified limits are excluded.
AI-Screening
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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
CONTACT
P
Physicians interested in becoming principal investigators please contact
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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