Response Pharmaceuticals has commenced a Phase II clinical trial to evaluate RDX-002 for managing weight rebound in individuals who have discontinued Glucagon-like peptide 1 (GLP-1) agonist therapy. The double-blind study will assess the drug's efficacy and tolerability over a 12-week period, with results anticipated in the latter half of 2025. This initiative addresses a critical unmet need in weight management, as many patients experience weight regain after stopping GLP-1 agonists.
RDX-002 is designed to mitigate post-prandial triglyceride levels and enhance cardiometabolic risk factors. The drug is also being considered for patients on antipsychotic medication.
Mechanism of Action
RDX-002 functions as a potent, selective, and gut-specific inhibitor of intestinal microsomal triglyceride transfer protein (iMTP). By inhibiting iMTP, RDX-002 reduces the absorption of triglycerides and cholesterol after meals, potentially aiding in weight management and improving cardiometabolic health. This targeted approach minimizes systemic exposure, potentially reducing off-target effects.
Clinical Trial Design
The Phase II trial includes participants who have previously achieved significant weight loss using GLP-1 agonist drugs but have since discontinued their use. The study aims to evaluate the impact of RDX-002 on preventing weight regain and improving metabolic parameters. The primary endpoint is the change in body weight from baseline, with secondary endpoints including changes in lipid profiles and other cardiometabolic markers.
Prior Clinical Experience
RDX-002 has undergone multiple Phase I and II clinical trials, with administration to 496 healthy subjects and patients for up to 84 days. These trials have demonstrated promising results, including reductions in post-prandial triglyceride and LDL cholesterol levels, as well as contributions to weight reduction. The drug has also shown good initial tolerability in studies involving antipsychotic-induced weight gain (AIWG).
Executive Commentary
Response Pharmaceuticals founder and CEO Eric Keller stated, "In our initial studies in antipsychotic-induced weight gain (AIWG), RDX-002 has shown promise in counteracting weight gain associated with the use of common anti-psychotics with good initial tolerability. We are excited to evaluate its effect in this second and important weight management setting while we continue development for AIWG."
Upcoming Presentation
Response Pharmaceuticals is scheduled to present findings from a proof-of-concept study of RDX-002 at Obesity Week 2024 in San Antonio.
