Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy

Официальное название

Phase 2 Randomized, Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Icovamenib in Participants With Type 2 Diabetes Not Achieving Glycemic Targets Despite GLP-1-Based Therapy

Обзор

This is a phase 2 randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes (T2D) not achieving glycemic targets despite Ozempic-based therapy.

Подробное описание

This study is a 52-week, phase 2 trial designed to examine whether treatment with icovamenib in participants with T2D who are currently on an Ozempic-based therapy will result in a greater reduction in HbA1c than Ozempic-based therapy alone. The current trial investigates participants who have used Ozempic for at least 3 months prior to screening whose HbA1c remains above the target established by the ADA.

Вмешательства

• Препарат icovamenib 100 mg
  icovamenib 100 mg
• Препарат Placebo
  Matching placebo

Первичные конечные точки

• To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control [Срок оценки: 26 weeks]

Вторичные конечные точки (7)

• To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control [Срок оценки: 12 weeks]
• To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control [Срок оценки: 52 weeks]
• To compare the change in fasting plasma glucose with icovamenib versus placebo during the off-treatment Follow-up Period [Срок оценки: 26 weeks]
• To compare the safety and tolerability of icovamenib versus placebo [Срок оценки: 52 weeks]
• To compare the safety and tolerability of icovamenib versus placebo [Срок оценки: 52 weeks]
• To compare the safety and tolerability of icovamenib versus placebo [Срок оценки: 52 weeks]
• To compare the safety and tolerability of icovamenib versus placebo [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Males or females, age ≥18 years and ≤70 years
• Have been diagnosed with T2D
• Taking Ozempic (semaglutide injection) and have been treated with lifestyle management and 0 to 2 additional antihyperglycemic medications (metformin and/or SGLT2 inhibitor) with a stable dose of all medications for at least 3 months prior to screening

• If participants are taking metformin, they must be on a minimum stable dose of ≥500 mg/day
• Participants must be on a minimum stable dose of Ozempic ≥0.5 mg/week
• Have HbA1c ≥7.5 and ≤9.5%
• Have a BMI 25 to 40 kg/m2
• Female participants of childbearing potential must have a negative pregnancy test, must be non-lactating, must be willing to have additional pregnancy tests during the study, must agree to the sex and contraception requirements.
• Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.

Критерии исключения

• Have type 1 diabetes mellitus or a secondary form of diabetes
• Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening
• Have a history of severe hypoglycemia (defined by the occurrence of hypoglycemia symptoms requiring the assistance of another person for recovery) in the 6 months prior to screening or a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms as judged by the investigator
• Have personal or family history (first-degree relative) of MEN1 or MEN2 or medullary thyroid carcinoma
• Use of GLP-1 RA other than Ozempic (semaglutide injection), dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, DPP4I, bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening
• Have FPG ≥240 mg/dL

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 · 17 центров

• Central Research Associates, LLC dba Flourish Research — Birmingham
• Hope Clinical Research — Canoga Park
• Ark Clinical Research — Long Beach
• Catalina Research Institute, LLC — Montclair
• Paradigm Clinical Research Centers, LLC — San Diego
• Southwest General Healthcare Center — Fort Myers
• Panax Clinical Research — Miami Lakes
• Flourish Research Orlando — Winter Park
• … и ещё 9 центров

Идентификаторы

NCT: NCT07502508 · COVALENT-212

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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