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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 16
- 主要终点
- To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Participants taking metformin must be on a minimum stable dose of ≥500 mg/day
- •Participants taking Ozempic must be on a minimum stable dose of ≥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 and must be willing to have additional pregnancy tests during the study.
- •Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.
排除标准
- •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
研究组 & 干预措施
Arm A: icovamenib 100 mg
Starting on Day 1, participants will receive icovamenib 100 mg QD in addition to their currently prescribed Ozempic (semaglutide injection)-based regimen. Treatment will last for 12 weeks.
At Week 12, participants will continue on a stable dose of their baseline Ozempic-based regimen. The total duration of the trial is approximately 56 weeks (including screening and follow-up)
干预措施: icovamenib 100 mg (Drug)
Arm B: matching placebo 100 mg
Starting on Day 1, participants will receive icovamenib 100 mg matching placebo QD in addition to their currently prescribed Ozempic (semaglutide injection)-based regimen. Treatment will last for 12 weeks.
At Week 12, participants will continue on a stable dose of their baseline Ozempic-based regimen. The total duration of the trial is approximately 56 weeks (including screening and follow-up).
干预措施: Placebo (Drug)
结局指标
主要结局
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
时间窗: 26 weeks
Mean change in HbA1c from baseline
次要结局
- To compare the safety and tolerability of icovamenib versus placebo(52 weeks)
- To compare the safety and tolerability of icovamenib versus placebo(16 weeks)
- To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control(52 weeks)
- To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control(12 weeks)
- To compare the change in fasting plasma glucose with icovamenib versus placebo during the off-treatment Follow-up Period(26 weeks)
- To compare the safety and tolerability of icovamenib versus placebo(12 weeks)