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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Parts A and C are sequential: Part B is crossover

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Part A is Double-Blinded, Parts B and C are Open-Label

Study Groups

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LY4057996 Part A (Cohorts A1-A5)

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

Group Type EXPERIMENTAL

LY4057996 SC

Intervention Type DRUG

Administered SC

LY4057996 IV

Intervention Type DRUG

Administered IV

Placebo Part A (Cohort A1-A5)

Placebo administered SC and/or IV

Group Type PLACEBO_COMPARATOR

Placebo SC

Intervention Type DRUG

Administered SC

Placebo IV

Intervention Type DRUG

Administered IV

LY4057996 Part B

LY4057996 administered SC

Group Type EXPERIMENTAL

LY4057996 SC

Intervention Type DRUG

Administered SC

LY4057996 Part C

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

Group Type EXPERIMENTAL

LY4057996 SC

Intervention Type DRUG

Administered SC

Lispro SC

Intervention Type DRUG

Administered SC

Pre-study basal insulin SC

Intervention Type DRUG

Administered SC

Degludec Part A (Cohort A2-A5)

Degludec administered SC and/or IV

Group Type ACTIVE_COMPARATOR

Degludec SC

Intervention Type DRUG

Administered SC

Degludec IV

Intervention Type DRUG

Administered IV

Degludec Part B

Degludec administered SC

Group Type ACTIVE_COMPARATOR

Degludec SC

Intervention Type DRUG

Administered SC

Interventions

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LY4057996 SC

Administered SC

Intervention Type DRUG

LY4057996 IV

Administered IV

Intervention Type DRUG

Placebo SC

Administered SC

Intervention Type DRUG

Placebo IV

Administered IV

Intervention Type DRUG

Degludec SC

Administered SC

Intervention Type DRUG

Lispro SC

Administered SC

Intervention Type DRUG

Degludec IV

Administered IV

Intervention Type DRUG

Pre-study basal insulin SC

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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, 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% 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) 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes