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Recruiting NCT06945406

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

Phase I Interventional Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LY4057996 SC, LY4057996 IV, Placebo SC, Placebo IV.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug LY4057996 SC
    Administered SC
  • Drug LY4057996 IV
    Administered IV
  • Drug Placebo SC
    Administered SC
  • Drug Placebo IV
    Administered IV
  • Drug Degludec SC
    Administered SC
  • Drug Lispro SC
    Administered SC
  • Drug Degludec IV
    Administered IV
  • Drug Pre-study basal insulin SC
    Administered SC

Primary outcome measures

  • 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 [Time frame: Baseline to Study Completion (Up to 47 Weeks)]
Secondary outcome measures (4)
  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4057996 [Time frame: Baseline to Study Completion (Up to 47 Weeks)]
  • PK: Maximum Concentration (Cmax) of LY4057996 [Time frame: Baseline to Study Completion (Up to 47 Weeks)]
  • Pharmacodynamic (PD): Change from Baseline in Fasting Glucose [Time frame: Baseline to Study Completion (Up to 47 Weeks)]
  • PD: AUC of Glucose Infusion Rate (GIR) [Time frame: Baseline Up to 10 weeks]

Eligibility criteria

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Basic science

Study locations

Germany · 1 center
  • Profil Institut für Stoffwechselforschung — Neuss

Identifiers

NCT: NCT06945406 · 27329 · 2024-519151-28-00 · J6B-MC-YKAA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗