Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets

Официальное название

A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets Despite Antihyperglycemic Medications

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 who are not achieving glycemic targets despite antihyperglycemic medications.

Подробное описание

This study is a 52-week, Phase 2 trial is designed to examine whether treatment with icovamenib in participants with T2D who are currently on standard-of-care antihyperglycemic medications (metformin, SGLT2 inhibitor, alogliptin, or sitagliptin) plus lifestyle management will result in a greater reduction in HbA1c than those therapies alone. The trial investigates participants who have been on a stable dose of their antihyperglycemic medication(s) for at least 3 months prior to screening whose HbA1c remains above the target established by the American Diabetes Association (ADA).

Вмешательства

• Препарат icovamenib 100mg
  icovamenib 100mg
• 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 ≤75 years
• Diagnosed with T2D
• Have been treated with lifestyle management with 1 to 3 antihyperglycemic medications: metformin, SGLT2i, alogliptin, or sitagliptin with a stable dose 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)
• Have HbA1c ≥7.5 and ≤10.5%
• Have a BMI ≤32 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, and 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 positive GAD autoantibody result within 60 days 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
• Use of GLP-1 RA, dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, \[linagliptin, saxagliptin (these 2 are drugs within DPP-4i class)\], bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening
• Have fasting triglyceride ≥500 mg/dL
• Have an eGFR <60 mL/min/1.73 m2 by the CKD-EPI Creatinine Equation at screening
• Have impaired liver function, defined as screening AST or ALT >1.2×ULN, and/or total bilirubin >ULN

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 · 18 центров

• Central Research Associates, LLC dba Flourish Research — Birmingham
• Hope Clinical Research — Canoga Park
• Ark Clinical Research — Fountain Valley
• 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
• … и ещё 10 центров

Идентификаторы

NCT: NCT07502495 · COVALENT-211

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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