Идёт набор NCT06945406

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

Фаза I С лечением Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: LY4057996 SC, LY4057996 IV, Placebo SC, Placebo IV.
Кому может быть актуально: Состояния в реестре: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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 [Срок оценки: Baseline to Study Completion (Up to 47 Weeks)]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

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

Критерии исключения

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