Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: icovamenib 100 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Drug icovamenib 100 mg
icovamenib 100 mg - Drug Placebo
Matching placebo
Primary outcome measures
- To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control [Time frame: 26 weeks]
Secondary outcome measures (7)
- To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control [Time frame: 12 weeks]
- To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control [Time frame: 52 weeks]
- To compare the change in fasting plasma glucose with icovamenib versus placebo during the off-treatment Follow-up Period [Time frame: 26 weeks]
- To compare the safety and tolerability of icovamenib versus placebo [Time frame: 52 weeks]
- To compare the safety and tolerability of icovamenib versus placebo [Time frame: 52 weeks]
- To compare the safety and tolerability of icovamenib versus placebo [Time frame: 52 weeks]
- To compare the safety and tolerability of icovamenib versus placebo [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 17 centers
- 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
- … and 9 more centers
Identifiers
NCT: NCT07502508 · COVALENT-212