Clinical Trials

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. 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 have completed clinical trials non-HCM and stable angina:

IMPROVE-HCM Phase 2 Clinical Trial

IMPROVE-HCM (NCT04826185) is a randomized, double-blind, placebo-controlled clinical trial investigating the safety and efficacy of ninerafaxstat 200 mg BID dosed for 12 weeks in 67 patients with nHCM. The primary objective of the study was to evaluate the safety and tolerability of ninerafaxstat in patients with symptomatic nHCM and objective evidence of exercise limitation through evaluation of incidence and severity of treatment emergent adverse events. Efficacy evaluations included exercise responses measured by standardized cardiopulmonary exercise testing and patient-reported symptoms.

IMPROVE-ISCHEMIA Phase 2 Clinical Trial: Obstructive Coronary Artery Disease

IMPROVE-ISCHEMIA (NCT04826172) is a randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability of ninerafaxstat in patients with stable angina and chronic coronary syndrome treated for 8 weeks on top of current anti-anginals. The trial further evaluated the anti-ischemic effects of ninerafaxstat through assessment of myocardial blood flow and myocardial functional response to ischemia using dobutamine stress echocardiography.

We are currently recruiting patients with HFpEF for IMPROVE-DiCE Part 2:

IMPROVE-DiCE Phase 2 Clinical Trial: Part 1: Cardiac Energetics in Patients with Type 2 Diabetes and early stage heart failure (pre-HFpEF), Part 2: Cardiac energetics, function and symptoms in patients with Type 2 Diabetes and HFpEF

IMPROVE-DiCE (NCT04826159) is the first clinical trial utilizing multi-nuclear and state-of-the-art hyperpolarized MR spectroscopy to quantify the metabolic and energetic responses to an investigational metabolic modulator in cardiovascular disease. It is a two-part, Phase 2 clinical trial evaluating the safety, tolerability and pharmacodynamic effects of ninerafaxstat.

Part 1 enrolled pre-HFpEF patients with type 2 diabetes and obesity and demonstrated normalization of cardiac energetics, significant reduction in cardiac steatosis and improvements to the rate of diastolic filling, an important component of heart failure. The results of Part 1 were presented at the European Society of Cardiology Congress in August 2022.

Part 2 of IMPROVE-DiCE enrolls symptomatic patients with cardiometabolic HFpEF and will assess the impact of ninerafaxstat on cardiac energetics, diastolic function, functional capacity and heart failure symptoms.

The trial is being conducted at the Oxford Centre for Clinical Magnetic Resonance Research (OCMR), Radcliffe Department of Medicine at the University of Oxford, UK and is being led by Professor Oliver Rider.

Please refer to www.clinicaltrials.gov for additional clinical trial information.