RDX-002, Response Pharmaceuticals’ lead candidate, is a first-in-class, potent, selective, and gut-specific small molecule inhibitor of microsomal triglyceride transfer protein (MTP) that is not systemically bioavailable. RDX-002 has been studied in multiple Phase 1 and Phase 2 clinical trials encompassing approximately 500 healthy subjects and patients dosed for up to 84 days. In these studies, RDX-002 was well tolerated and lowered post-prandial triglycerides and free fatty acids, reduced LDL cholesterol, lowered HbA1c in patients with diabetes, and reduced body weight without untoward side effects.
Clinical Trials
Completed Study: RDX-002-022-009 (NCT05857566) is a single-center Phase 1b trial enrolling 24 normal, healthy subjects to receive olanzapine for two weeks +/- RDX-002 for the second week. This study aims to determine the effect of RDX-002 on postprandial triglycerides in olanzapine-treated patients, explore effects on body weight and fasting lipids and demonstrate a lack of impact of RDX-002 on the steady-state pharmacokinetics of olanzapine. Read More...
Planned Study: RDX-002-023-010 is a double-blind, randomized, placebo-controlled, multicenter Phase 2b trial enrolling approximately 120 patients with schizophrenia and bipolar disease initiating olanzapine treatment, and will test the addition of RDX-002 or placebo for 12 weeks.
The primary objective of the study is the difference in the mean percent change in body weight from baseline to week 12. Secondary and exploratory endpoints will include changes in postprandial triglycerides and fasting lipids. The trial is expected to begin enrollment in Q4 2024.
Active Study: RDX-002-024-011 (NCT06640972) is a double-blind, randomized, placebo-controlled, single center Phase 2 trial enrolling approximately 40 patients discontinuing GLP-1 agonists semaglutide and tirzepatide for the treatment of obesity.
The primary objective of the study is to assess the difference in the mean percent change of post-prandial triglycerides from baseline in patients receiving RDX-002 vs placebo following discontinuation of GLP-1 agonist treatment for obesity. Secondary and exploratory endpoints will include changes in body weight and fasting lipids. The trial is actively enrolling.
For more information on and if you are interested in participating in our Clinical trials, please visit our Clinical page and follow the NCT link next to your study of interest.
Increased Mortality in Schizophrenia Due to Cardiovascular Disease – A Non-Systematic Review of Epidemiology, Possible Causes, and Interventions
Petter Andreas Ringen, John A. Engh, Astrid B. Birkenaes, Ingrid Dieset, and Ole A. Andreassen: Front Psychiatry; 2014; 5: 137.