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RecruitingNCT06945406YKAAUpdated Sep 29, 2026

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

A Phase 1 interventional study of LY4057996 SC and LY4057996 IV in Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by Eli Lilly and Company. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
124 participants (estimated)

Study arms

  • Experimental
    LY4057996 Part A (Cohorts A1-A5)

    LY4057996 administered subcutaneously (SC) and/or intravenously (IV)

    Drug: LY4057996 SC · Drug: LY4057996 IV

  • Placebo comparator
    Placebo Part A (Cohort A1-A5)

    Placebo administered SC and/or IV

    Drug: Placebo SC · Drug: Placebo IV

  • Experimental
    LY4057996 Part B

    LY4057996 administered SC

    Drug: LY4057996 SC

  • Experimental
    LY4057996 Part C

    LY4057996 and interventions of pre-study basal insulin and Lispro administered SC

    Drug: LY4057996 SC · Drug: Lispro SC · Drug: Pre-study basal insulin SC

  • Active comparator
    Degludec Part A (Cohort A2-A5)

    Degludec administered SC and/or IV

    Drug: Degludec SC · Drug: Degludec IV

  • Active comparator
    Degludec Part B

    Degludec administered SC

    Drug: Degludec SC

Interventions

  • DrugLY4057996 SC

    Administered SC

  • DrugLY4057996 IV

    Administered IV

  • DrugPlacebo SC

    Administered SC

  • DrugPlacebo IV

    Administered IV

  • DrugDegludec SC

    Administered SC

  • DrugLispro SC

    Administered SC

  • DrugDegludec IV

    Administered IV

  • DrugPre-study basal insulin SC

    Administered SC

05

What researchers measure

Primary outcomes

  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

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

    Time frame: Baseline to Study Completion (Up to 47 Weeks)

Secondary outcomes

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

    PK: AUC of LY4057996

    Time frame: Baseline to Study Completion (Up to 47 Weeks)

  2. PK: Maximum Concentration (Cmax) of LY4057996

    PK: Cmax of LY4057996

    Time frame: Baseline to Study Completion (Up to 47 Weeks)

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

    PD: Change from Baseline in Fasting Glucose

    Time frame: Baseline to Study Completion (Up to 47 Weeks)

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

    PD: AUC of GIR

    Time frame: Baseline Up to 10 weeks

06

Study locations

1 of 1 sites recruiting
  • Profil Institut für Stoffwechselforschung
    Neuss, 41460, Germany
    • · Contact · +49 (0) 2131 4018 180
    • Oliver Klein · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06945406
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Apr 25, 2025
Start date
May 16, 2025
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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