Phase 2 Study of Icovamenib Added to Ozempic for Adults 18 to 70 Years With Type 2 Diabetes Not Meeting Blood Sugar Goals

What this Trial Is About

Researchers are evaluating the efficacy and safety of icovamenib in adults with Type 2 Diabetes T2D who are not reaching their blood sugar targets despite using Ozempic-based therapy. This phase 2, randomized, double-blind, placebo-controlled trial focuses on participants who have used Ozempic for at least three months but still have HbA1c levels above the target set by the American Diabetes Association. The trial aims to see if adding icovamenib improves glycemic control compared to continuing Ozempic alone. Participants will be randomly assigned to receive either icovamenib 100 mg once daily or a matching placebo in addition to their current Ozempic regimen for 12 weeks. After this treatment period, all participants will continue their stable Ozempic-based therapy without the study drug. The entire trial duration, including screening and follow-up, is approximately 56 weeks. During the study, participants will have regular assessments to monitor blood sugar control, including HbA1c levels and fasting plasma glucose. Researchers will also track safety and tolerability throughout the 52-week period. The main goal is to compare how well icovamenib works against placebo in improving glycemic control over 12, 26, and 52 weeks while observing any side effects. Participants will be involved in scheduled visits and tests to evaluate these outcomes.

Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy