HealthyPhase 1NCT06280703
A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)
A Phase 1 study testing LY3938577, Insulin Degludec and Insulin Lispro in people with Healthy and Type 1 Diabetes Mellitus, run by Eli Lilly and Company at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Type 1 Diabetes Mellitus
- What is being tested?
- LY3938577, Insulin Degludec and Insulin Lispro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2024to 3 Oct 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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 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.
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- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Four-Part, Randomized, Double-Blind (Part A) and Open-Label (Part B, Part C, and Part D), Multi-Dose, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus
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.
Read more
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
- Healthy, Type 1 Diabetes Mellitus
- Being tested
- LY3938577, Placebo, Insulin Degludec, Insulin Lispro, Basal Insulin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3938577Drug
Administered Intravenously (IV)
PlaceboDrug
Administered Intravenously (IV)
Insulin DegludecDrug
Administered Intravenously (IV)
Insulin LisproDrug
Administered Intravenously (IV)
LY3938577Drug
Administered subcutaneously (SC)
PlaceboDrug
Administered subcutaneously (SC)
Insulin DegludecDrug
Administered SC
Basal InsulinDrug
Administered subcutaneously (SC)
Lispro Prandial InsulinDrug
Administered subcutaneously (SC)
| Study group | Role | What they receive |
|---|---|---|
| Part A Period 1: LY3938577 | Experimental | Single dose of LY3938577 administered intravenously (IV) in healthy participants. Receives: Drug: LY3938577 |
| Part A Period 1: Placebo | Placebo comparator | Single dose of Placebo administered intravenously (IV) in healthy participants. Receives: Drug: Placebo |
| 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. Receives: Drug: LY3938577; Drug: Insulin Lispro |
| 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. Receives: Drug: Insulin Degludec; Drug: Insulin Lispro |
| Part C: LY3938577 | Experimental | LY3938577 administered subcutaneously (SC) Receives: Drug: LY3938577 |
| Part C: Insulin Degludec | Active comparator | Insulin Degludec administered subcutaneously (SC) Receives: Drug: Insulin Degludec |
| Part A Period 2: LY3938577 | Experimental | Sequential dose of LY3938577 administered subcutaneously (SC). Receives: Drug: LY3938577 |
| Part A Period 2: Placebo | Placebo comparator | Sequential dose of Placebo administered subcutaneously (SC) Receives: Drug: Placebo |
| Part D Period 1: Basal Insulin and Lispro Prandial Insulin | Other | Pre-study basal insulin (provided by patient) and lispro prandial insulin administered SC Receives: Drug: Basal Insulin; Drug: Lispro Prandial Insulin |
| Part D Period 2: Lispro Prandial Insulin and LY3938577 | Experimental | Lispro prandial insulin and LY3938577 administered SC Receives: Drug: LY3938577; Drug: Lispro Prandial Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline up to Week 10
Part A: Number of Participants With Clinically Significant Changes in Vital Signs
Measured: Baseline up to Approximately Week 11
Part B: Number of Participants With Clinically Significant Changes in Vital Signs
Measured: Baseline up to Week 10
Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Measured: Baseline up to Approximately Week 11
Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Measured: 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
Measured: Predose on day 1 up to week 13 post dose
Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
PK: AUC of LY3938577 for SC administration
Measured: 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
Measured: 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
Measured: 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
Measured: Predose on day 1 up to week 13 post dose
Part A: PK: Maximum Observed Concentration (Cmax) of LY3938577
PK: Cmax of LY3938577
Measured: Predose on day 1 up to week 13 post dose
Part B: PK: Maximum Observed Concentration (Cmax) of LY3938577
PK: Cmax of LY3938577
Measured: Predose on day 1 up to week 13 post dose
Part C: PK: Concentration of LY3938577
Measured: Predose on day 1 up to week 13 post dose
Secondary outcomes (2)
Part B: Pharmacodynamic (PD): Area under the glucose infusion rate curve (GIR AUC) of LY3938577
Measured at different glucose levels in participants with T1DM
Measured: Predose up to day 14 post dose
Part C: PD: Glucose infusion rate (GIR) of LY3938577
Measured at different glucose levels in participants with T1DM
Measured: Predose up to day 14 post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 May 2024
- Primary completion3 Oct 2026
- Study completion3 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment Parallel (Part A) and Crossover design (Part B, Part C, and Part D)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280703
- Sponsor's protocol ID
- 18792
- Other IDs
- J4P-MC-IYAB, U1111-1301-8386, 2023-510365-10-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 20 Feb 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No