Recruiting NCT07502495

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

Phase II Interventional Type 2 Diabetes

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 100mg, Placebo.
Who it may be relevant to: Registry conditions: Type 2 Diabetes. Basic parameters: 18 years — 75 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 →

Unsure about the terms? Read our patient guide →

Official title

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

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 who are not achieving glycemic targets despite antihyperglycemic medications.

Detailed description

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).

Interventions

Drug icovamenib 100mg
icovamenib 100mg
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 ≤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.

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 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

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 · 18 centers

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
… and 10 more centers

Identifiers

NCT: NCT07502495 · COVALENT-211

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗