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| ID | Type | Description | Link |
|---|---|---|---|
| J4P-MC-IYAB | Other Identifier | Eli Lilly and Company | |
| U1111-1301-8386 | Other Identifier | Universal Trial Number | |
| 2023-510365-10-00 | Other Identifier | EU Trial Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Period 1: LY3938577 | Experimental | Single dose of LY3938577 administered intravenously (IV) in healthy participants. |
|
| Part A Period 1: Placebo | Placebo Comparator | Single dose of Placebo administered intravenously (IV) in healthy participants. |
|
| Part B: LY3938577 | Experimental | For each euglycemic and hyperglycemic clamps participants with T1DM will receive single doses of LY3938577 administered intravenously with Insulin Lispro administered at a constant low rate to cover individual participant's basal (fasting) insulin demand to maintain a stable glucose level. |
|
| Part B: Insulin Degludec | Active Comparator | For each euglycemic and hyperglycemic clamps participants with T1DM will receive single doses of Insulin Degludec administered intravenously with Insulin Lispro administered at a constant low rate to cover individual participant's basal (fasting) insulin demand to maintain a stable glucose level. |
|
| Part C: LY3938577 | Experimental | LY3938577 administered subcutaneously (SC) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3938577 | Drug | Administered Intravenously (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration. | A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Baseline up to Approximately Week 11 |
| Part B and D: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration. | A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Baseline up to Week 10 |
| Part A: Number of Participants With Clinically Significant Changes in Vital Signs | Baseline up to Approximately Week 11 | |
| Part B: Number of Participants With Clinically Significant Changes in Vital Signs | Baseline up to Week 10 | |
| Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters | Baseline up to Approximately Week 11 | |
| Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters | Baseline up to Week 10 | |
| Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 | PK: AUC of LY3938577 for intravenous administration | Predose on day 1 up to week 13 post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Pharmacodynamic (PD): Area under the glucose infusion rate curve (GIR AUC) of LY3938577 | Measured at different glucose levels in participants with T1DM | Predose up to day 14 post dose |
| Part C: PD: Glucose infusion rate (GIR) of LY3938577 |
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Inclusion Criteria:
Part A -
• Participants who are overtly healthy as determined by medical history and physical examination.
Parts B and C -
Part D -
All Parts -
Exclusion Criteria:
Parts B, C, and D -
Parts B and C -
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 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung | Recruiting | Neuss | 41460 | Germany |
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| Label | URL |
|---|---|
| A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM) | View source |
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Crossover Assignment Parallel (Part A) and Crossover design (Part B, Part C, and Part D)
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Double (Participant, Investigator) Double-Blind (Part A) and Open-Label (Part B, Part C, and Part D)
|
| Part C: Insulin Degludec | Active Comparator | Insulin Degludec administered subcutaneously (SC) |
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| Part A Period 2: LY3938577 | Experimental | Sequential dose of LY3938577 administered subcutaneously (SC). |
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| Part A Period 2: Placebo | Placebo Comparator | Sequential dose of Placebo administered subcutaneously (SC) |
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| Part D Period 1: Basal Insulin and Lispro Prandial Insulin | Other | Pre-study basal insulin (provided by patient) and lispro prandial insulin administered SC |
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| Part D Period 2: Lispro Prandial Insulin and LY3938577 | Experimental | Lispro prandial insulin and LY3938577 administered SC |
|
| Placebo | Drug | Administered Intravenously (IV) |
|
| Insulin Degludec | Drug | Administered Intravenously (IV) |
|
| Insulin Lispro | Drug | Administered Intravenously (IV) |
|
| LY3938577 | Drug | Administered subcutaneously (SC) |
|
| Placebo | Drug | Administered subcutaneously (SC) |
|
| Insulin Degludec | Drug | Administered SC |
|
| Basal Insulin | Drug | Administered subcutaneously (SC) |
|
| Lispro Prandial Insulin | Drug | Administered subcutaneously (SC) |
|
| Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 | PK: AUC of LY3938577 for SC administration | Predose on day 1 up to week 13 post dose |
| Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 | PK: AUC of LY3938577 | Predose on day 1 up to week 13 post dose |
| Part C: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 | PK: AUC of LY3938577 for SC administration | Predose on day 1 up to week 13 post dose |
| Part D: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 | PK: AUC of LY3938577 for SC administration | Predose on day 1 up to week 13 post dose |
| Part A: PK: Maximum Observed Concentration (Cmax) of LY3938577 | PK: Cmax of LY3938577 | Predose on day 1 up to week 13 post dose |
| Part B: PK: Maximum Observed Concentration (Cmax) of LY3938577 | PK: Cmax of LY3938577 | Predose on day 1 up to week 13 post dose |
| Part C: PK: Concentration of LY3938577 | Predose on day 1 up to week 13 post dose |
Measured at different glucose levels in participants with T1DM
| Predose up to day 14 post dose |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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