Clinical trials are an essential part of the process for bringing new medicines to market.
Clinical trials offer patients an opportunity to explore investigational new treatments when standard treatments are not sufficiently effective or no longer an option. By taking part in a clinical trial, patients can make an important contribution to ongoing research and help advance the medical community’s understanding of a disease.
We are currently recruiting patients for Phase 2 clinical trials:
IMB-101 IMPROVE-DiCE Phase 2a Study: Cardiac Energetics in Patients with Type 2 Diabetes
IMPROVE-DiCE is an open-label pharmacodynamic study that will assess the activity of IMB-101 on cardiac energetic reserve at rest and during stress, and to assess the safety and tolerability of IMB-101 in patients with Type 2 diabetes. The primary outcome will measure the change in cardiac PCr/ATP ratio at rest and with dobutamine stress (i.e., dobutamine stress-induced drop in PCr/ATP ratio from its resting value at the same time point) measured by 31P-MRS over an eight-week period, while also examining the safety and tolerability of IMB-101.
IMPROVE-Ischemia is a randomized, double-blind, placebo-controlled, exploratory study that will examine the safety and tolerability of IMB-101 in patients with obstructive CAD and inducible ischemia. The study will examine the change in number of ischemic segments during hyperemia (ischemia defined as absolute MBF ≤2.3 ml/kg/min) as measured by adenosine stress 15O-H2O PET in 60 obstructive CAD patients treated with 200 mg BID of IMB1018972 over an 8-week period. The measure of incidence and severity of treatment emergent Adverse Events (AEs), as well as well as incidence of treatment emergent Severe Adverse Events (SAEs) will also be examined.
IMPROVE-HCM is a randomized, double-blind, placebo-controlled study that will assess the safety, tolerability, and efficacy of IMB-101 in patients with non-obstructive hypertrophic cardiomyopathy (HCM). This study will measure the change from baseline of peak oxygen consumption (VO2) and oxygen uptake efficiency slope (OUES), measured by standardized cardiopulmonary exercise testing (CPET) in 60 non-obstructive HCM patients treated with 200 mg BID of IMB-1018972 over a 12-week period. Incidence and severity of treatment emergent Adverse Events (AEs), as well as incidence of treatment emergent Severe Adverse Events (SAEs) will also be examined.