A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes

NCT06945406
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Recruiting
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Participants
124
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Lead sponsor
Eli Lilly and Company
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Start date
2025-05-16
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Number of sites
1
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Summary
The purpose of this study is to evaluate how well LY4057996 is tolerated and what side effects may occur in healthy participants and participants with Type 1 and Type 2 Diabetes. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4057996 gets into the bloodstream and how long it takes the body to eliminate it. The study will last 11 weeks for Part A1-A2, 4 weeks for A3-A5, 6 weeks for Part B and 7 weeks for Part C, all approximations, excluding a screening period.
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Acronym
YKAA
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Short title
A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes
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Official title
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-03-01
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First posted
2025-04-25
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Registry last updated
2026-09-29
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Primary completion date
2027-03-01
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Start date
2025-05-16
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Participants
124
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Participant count basis
Estimated
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Planned participants
124
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Protocol amendments
2
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06945406
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ClinicalTrials.gov ID
NCT06945406
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Registry record
Open registry record
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Allocation
Randomised
Model
Sequential
Purpose
Basic science
Masking
Double masking
Masking description
Part A is Double-Blinded, Parts B and C are Open-Label
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration

    Timeframe: Baseline to Study Completion (Up to 47 Weeks)

    A summary of SAEs and AEs regardless of causality, will be reported in the Reported Adverse Events module

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4057996

    Timeframe: Baseline to Study Completion (Up to 47 Weeks)

    PK: AUC of LY4057996

  2. PK: Maximum Concentration (Cmax) of LY4057996

    Timeframe: Baseline to Study Completion (Up to 47 Weeks)

    PK: Cmax of LY4057996

  3. Pharmacodynamic (PD): Change from Baseline in Fasting Glucose

    Timeframe: Baseline to Study Completion (Up to 47 Weeks)

    PD: Change from Baseline in Fasting Glucose

  4. PD: AUC of Glucose Infusion Rate (GIR)

    Timeframe: Baseline Up to 10 weeks

    PD: AUC of GIR

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

Part A for Healthy Participants:

  • Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment

Part A for Type 2 Diabetes (T2DM) Participants:

  • Are participants with T2DM diagnosed greater than 1 year before enrollment,
  • On basal insulin therapy, insulin glargine, insulin detemir, or insulin degludec, greater than 10 units per day for at least 6 months (for Cohort 5 only)
  • Glycated hemoglobin (HbA1c) 6.5% to 9.5% inclusive at screening

Part B

  • Have Type 1 Diabetes (T1D) for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening
  • HbA1c 6% to 8.5% inclusive at screening

Part C

  • Have T1D for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening
  • HbA1c 6 to 8.5% inclusive at screening

All Parts

  • Have blood pressure of less than 140/90 millimeters of mercury (mmHg) for healthy participants or 150/90 mmHg for participants with diabetes and pulse rate of less than 90 beats per minute (bpm) (supine)
  • No hypoglycemia unawareness for all Type 1 and Type 2 Diabetes participants

  • Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 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 6 months prior to screening

All Parts

  • Cardiovascular: no significant history of cardiovascular disease (CVD)
  • Gastrointestinal: have gastroparesis or have undergone gastric surgery
  • Hepatic: have acute or chronic hepatitis
Sources for eligibility
clinicaltrials.gov

  • Profil Institut für StoffwechselforschungNeuss, GermanyRecruiting
Sources for sites
clinicaltrials.gov

  • 2024-519151-28-00
  • J6B-MC-YKAA
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (1)