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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
icovamenib 100 mg
Matching placebo
Central Research Associates, LLC dba Flourish Research
Birmingham, Alabama, United States
RECRUITINGTo demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
Mean change in HbA1c from baseline
Time frame: 26 weeks
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
Mean change in HbA1c from baseline
Time frame: 12 weeks
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
Mean change in HbA1c from baseline
Time frame: 52 weeks
To compare the change in fasting plasma glucose with icovamenib versus placebo during the off-treatment Follow-up Period
Mean change in fasting plasma glucose from baseline
Time frame: 26 weeks
To compare the safety and tolerability of icovamenib versus placebo
Incidence of AEs
Time frame: 52 weeks
To compare the safety and tolerability of icovamenib versus placebo
Incidence of TEAEs
Time frame: 52 weeks
To compare the safety and tolerability of icovamenib versus placebo
Incidence of SAEs
Time frame: 52 weeks
To compare the safety and tolerability of icovamenib versus placebo
Incidence of early discontinuation of trial intervention due to TEAEs
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Canoga Park, California, United States
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Long Beach, California, United States
RECRUITINGCatalina Research Institute, LLC
Montclair, California, United States
RECRUITINGParadigm Clinical Research Centers, LLC
San Diego, California, United States
RECRUITINGSouthwest General Healthcare Center
Fort Myers, Florida, United States
RECRUITINGPanax Clinical Research
Miami Lakes, Florida, United States
RECRUITINGFlourish Research Orlando
Winter Park, Florida, United States
RECRUITINGDavid Kavtaradze MD, Inc
Cordele, Georgia, United States
RECRUITINGExcel Clinical Research
Las Vegas, Nevada, United States
RECRUITING...and 7 more locations
Time frame: 12 weeks