Completed Study: RDX-002-022-009 (Clinical Trials Gov) 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.

​

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 outcome 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.

​

Planned Study: RDX-002-024-011 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 expected to begin enrollment in Q3 2024.

​

​