A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide

Официальное название

A Parallel-Group Treatment, Phase 2, Double-Blind Study of Once-Weekly Subcutaneous LY3457263 Compared to Placebo in Participants With Type 2 Diabetes Mellitus on a Stable Dose of Semaglutide or Tirzepatide Who Failed to Achieve HbA1c Goal

Обзор

The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.

Вмешательства

• Препарат LY3457263
  Administered SC
• Препарат Placebo
  Administered SC

Первичные конечные точки

• Change from Baseline in Hemoglobin A1c (HbA1c) [Срок оценки: Baseline, Week 24]

Вторичные конечные точки (2)

• Change from Baseline in Fasting Serum Glucose [Срок оценки: Baseline, Week 24]
• Percent Change from Baseline in Body Weight [Срок оценки: Baseline, Week 24]

Критерии участия

Критерии включения

• Have type 2 diabetes
• Have HbA1c ≥7.5% to ≤10.5% at screening
• Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening
• Have had a stable body weight for the three months prior to screening
• On stable treatment dose of one of the following incretins for at least three months prior to screening:

• Injectable semaglutide (1 and 2 milligram (mg))
• Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg)

Критерии исключения

• Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma
• Have a prior or planned surgical treatment for obesity
• Have any of the following cardiovascular conditions within three months prior to screening:

• acute myocardial infarction
• cerebrovascular accident (stroke)
• unstable angina, or
• hospitalization due to congestive heart failure
• Have used insulin to control blood glucose within the past year (short-term use allowed)
• Current use of prohibited oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the prohibited OAM treatment was discontinued at least 3 months prior to screening

• If participant has been on stable doses (for at least three months) of up to three permitted OAMs (limited to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors, sulfonylurea, and/or thiazolidinediones (TZD), they are permitted to participate in the study
• Have taken any medications or alternative remedies for weight loss within three months prior to screening

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 25 центров

• Helios Clinical Research - Phoenix — Phoenix
• Wolverine Clinical Trials — Santa Ana
• Renstar Medical Research — Ocala
• Oviedo Medical Research — Oviedo
• Balanced Life Health Care Solutions/SKYCRNG — Lawrenceville
• Physicians Research Associates — Lawrenceville
• Rophe Adult and Pediatric Medicine/SKYCRNG — Union City
• North Georgia Clinical Research — Woodstock
• … и ещё 17 центров

Великобритания · 10 центров

• FutureMeds - Birmingham — Birmingham
• Layton Medical Centre — Blackpool
• Southmead Hospital — Bristol
• FutureMeds - Liverpool — Bromborough
• Futuremeds-Newcastle — Newcastle
• Newquay Health Centre — Newquay
• George Eliot Hospital — Nuneaton
• The Adam Practice — Poole
• … и ещё 2 центра

Канада · 9 центров

• Centricity Research Brampton Endocrinology — Brampton
• Ecogene-21 — Chicoutimi
• Winterberry Research Inc. — Hamilton
• Viacar Recherche Clinique — Longueuil
• G A Research Associates — Moncton
• Bluewater Clinical Research Group Inc. — Sarnia
• Maple Leaf Research — Toronto
• Diabetes Heart Research Centre — Toronto
• … и ещё 1 центр

Польша · 9 центров

• Legeartis - Poradnie Specjalistyczne — Bialystok
• Centrum Badan Klinicznych PI-House sp. z o.o. — Gdansk
• Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET — Krakow
• Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna — Lodz
• Ekamed — Lublin
• Private Practice - Dr. Robert Witek — Tarnów
• NBR Polska — Warsaw
• Szpital Czerniakowski — Warsaw
• … и ещё 1 центр

Германия · 5 центров

• InnoDiab Forschung Gmbh — Essen
• Velocity Clinical Research, Leipzig — Leipzig
• Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut — Leipzig
• Institut für Diabetesforschung GmbH Münster — Münster
• RED-Institut GmbH — Oldenburg

Пуэрто-Рико · 2 центра

• Centro de Endocrinologia Alcantara Gonzalez — Bayamón
• Mgcendo Llc — San Juan

Идентификаторы

NCT: NCT06897475 · 27344 · 2024-520328-27-00 · J1R-MC-GZFD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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