A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)

Healthy Clinical Trial

Official title:

A Three-Part, Randomized, Double-Blind (Part A) and Open-Label (Part B and Part C), Multi-Dose, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06280703
• Other study ID #: 18792
• Secondary ID: J4P-MC-IYABU1111
• Status: Recruiting
• Phase: Phase 1
• Start date: May 15, 2024
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]Lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 three parts (A, B, and C). Healthy participants in part A will receive one single dose of LY3938577 or a placebo, whereas participants in Parts B and C with T1DM will receive single doses of either LY3938577 or Insulin Degludec given via intravenous (IV) infusion.

The study will last up to approximately 5.5, 10 and 13 weeks for parts A, B, and C, respectively, including screening period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion 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).

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.

Exclusion Criteria:

Parts B and C -

• 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.

• Have been treated with Glucagon-like Peptide-1 Receptor Agonists (GLP1-RA), Dipeptidyl Peptidase 4 (DPP4) inhibitor, Glucose-dependent Insulinotropic Polypeptide (GIP) agonists, Metformin, or Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors within the previous 3 months.

• Have received systemic or inhaled glucocorticoid therapy (excluding topical, intraarticular, and intraocular preparations) for more than 14 consecutive days within 4 weeks before screening.

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:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Healthy
• Type 1 Diabetes Mellitus

Intervention

Drug:
• LY3938577
Administered Intravenously (IV)
• Placebo
Administered Intravenously (IV)
• Insulin Degludec
Administered Intravenously (IV)
• Insulin Lispro
Administered Intravenously (IV)

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung	Neuss	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Week 5.5
Primary	Part B: 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
Primary	Part A: Number of Participants With Clinically Significant Changes in Vital Signs		Baseline up to Week 5.5
Primary	Part B: Number of Participants With Clinically Significant Changes in Vital Signs		Baseline up to Week 10
Primary	Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters		Baseline up to Week 5.5
Primary	Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters		Baseline up to Week 10
Primary	Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577	PK: AUC of LY3938577	Predose on day 1 up to day 8 post dose
Primary	Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577	PK: AUC of LY3938577	Predose on day 1 up to day 14 post dose
Primary	Part A: PK: Maximum Observed Concentration (Cmax) of LY3938577	PK: Cmax of LY3938577	Predose on day 1 up to day 8 post dose
Primary	Part B: PK: Maximum Observed Concentration (Cmax) of LY3938577	PK: Cmax of LY3938577	Predose on day 1 up to day 14 post dose
Primary	Part C: PK: Concentration of LY3938577		Predose on day 1 up to day 14 post dose
Secondary	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
Secondary	Part C: PD: Glucose infusion rate (GIR) of LY3938577	Measured at different glucose levels in participants with T1DM	Predose up to day 14 post dose

External Links

•   A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)