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Official title A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)
ClinicalTrials.gov ID: NCT06280703
What this study is testing
What is LY3938577?
LY3938577 is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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). Part D -
You likely can't join if
- Parts B, C, and D -
- Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within the last 6...
- Have had any episodes of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia), hypoglycemia...
- Have been treated with Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA), Dipeptidyl Peptidase 4 (DPP4) inhibitor, Glucose-dependent...
- Have received systemic or inhaled glucocorticoid therapy (excluding topical, intraarticular, and intraocular preparations) for more than 14...
- Have been treated with Dipeptidyl peptidase-4 (DPP-IV) inhibitors, GLP-1 RA, GIP/GLP-1 RA, Metformin, Pramlintide, SGLT2 inhibitors, or Neutral...
See the full eligibility 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). Part D -
- Have T1DM for at least 1 year with a fasting C-peptide level of 0.20 nmol/L or less, or non-fasting C-peptide level of 0.30 nmol/L or less.
- HbA1c between 6% to 8.5% inclusive.
- Insulin pump users with a total daily basal dose between 15 to 45 International Unit (IU).
- Insulin multiple daily injection users (glargine or degludec insulin) with a total daily insulin dose between 0.3 to \<1.2 (I)U/kg/day.
- No hypoglycaemia unawareness.
- Basal insulin dose that is between 30% to 70% of the total daily insulin dose
- Are able to complete the exercise challenge test. 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.
- Parts B, C, and D -
- 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. Parts B and C -
- Have been treated with Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA), Dipeptidyl Peptidase 4 (DPP4) inhibitor, Glucose-dependent Insulinotropic Polypeptide (GIP) agonists, Metformin, or Sodium-Glucose Transport...
- Have received systemic or inhaled glucocorticoid therapy (excluding topical, intraarticular, and intraocular preparations) for more than 14 consecutive days within 4 weeks before screening. Part D -
- Have been treated with Dipeptidyl peptidase-4 (DPP-IV) inhibitors, GLP-1 RA, GIP/GLP-1 RA, Metformin, Pramlintide, SGLT2 inhibitors, or Neutral Protamine Hagedorn (NPH) insulin within the previous 3 months. 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Neuss, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Neuss, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.