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 are currently recruiting patients for Phase 2 clinical trials:

IMPROVE-HCM Phase 2 clinical trial

IMPROVE-HCM is a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, and efficacy of ninerafaxstat in patients with non-obstructive hypertrophic cardiomyopathy (nHCM). 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 nHCM patients treated with 200 mg BID of ninerafaxstat over a 12-week period. Incidence and severity of treatment emergent Adverse Events will also be examined.

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


IMPROVE-DiCE Phase 2a Study: 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 heart failure with preserved ejection fraction.

The IMPROVE-DiCE clinical trial, Part 1 is a Phase 2, target engagement study in patients with diabetes, obesity and early stage of heart failure (pre-HFpEF). The primary outcome measures is the change in cardiac PCr/ATP ratio at rest measured by 31P-MRS over an eight-week period, while also examining the safety and tolerability of ninerafaxstat. This part of the study completed end of 2021 and data will be presented at the ESC in August 2022.

Part 2 of the study will assess the effect of ninerafaxstat 200 mg BID in patients with cardiometabolic HFpEF measuring change in cardiac energetics, cardiac function at rest and during exercise, and measures of patient symptoms.

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


IMPROVE-ISCHEMIA Phase 2 Study: Obstructive Coronary Artery Disease

IMPROVE-ISCHEMIA is a randomized, double-blind, placebo-controlled, Phase 2 study that will examine the safety and tolerability of ninerafaxstat in patients with obstructive coronary arterial disease (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 ninerafaxstat over an 8-week period. The measure of incidence and severity of treatment emergent Adverse Events will also be examined.

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

We do not currently accept or grant requests for expanded access to any of our investigational drugs outside of clinical trials.

If we begin to provide expanded access to any of our investigational drugs, this website and policy will be updated to notify the public of the procedures for requesting expanded access.