Response Pharmaceuticals, Inc., a clinical-stage company focused on weight management and metabolic health in high-risk populations, today announced the early completion of enrollment in a Phase 2 trial evaluating the company’s drug candidate, RDX-002, for post-GLP-1 weight rebound. The study is assessing the effect of RDX-002, an investigational first-in-class inhibitor of intestinal microsomal triglyceride transfer protein (iMTP), on post-prandial triglyceride levels as well as body weight and other cardiometabolic risk factors in individuals discontinuing the GLP-1 agonists, semaglutide or tirzepatide, for the treatment of obesity.
“GLP-1 agonists have been transformative for patients struggling with obesity. However, recent data from several studies (STEP-1, STEP-4, SURMOUNT-4) suggest that following discontinuation of the GLP-1 drugs semaglutide and tirzepatide, most patients rapidly regain much of the weight lost; and with the weight regain, the risk of developing obesity-related comorbidities, such as high blood pressure, cardiovascular disease and Type 2 diabetes, returns,” says Eric Keller, Response Pharmaceuticals’ CEO. “Giving patients a tool to maintain their weight loss and the associated cardiometabolic benefit remains a considerably underserved medical need.”
“Response’s lead investigational candidate, RDX-002, has shown promise in a separate, recently completed Phase 1 study focusing on another drug-induced weight management setting, anti-psychotic induced weight gain (AIWG), making it a strong candidate for evaluation in preventing weight rebound following GLP-1 agonist discontinuation,” Dr. Bill Sasiela, Response Pharmaceuticals’ Chief Medical Officer stated. “The rapid enrollment of this study, which completed 12 months ahead of our projected schedule, exceeded all expectations and reinforces the considerable and growing unmet need associated with post GLP-1 weight rebound given the wide-spread use of these novel weight loss drugs. We look forward to reporting data from this study at the end of the second quarter of 2025 as we prepare for a Phase 2b study in our lead indication, AIWG.”
The trial (NCT06640972) is a double-blind study evaluating the efficacy and tolerability of RDX-002 over 12 weeks in patients who have lost significant weight using GLP-1 agonist drugs but are planning to discontinue the treatment.
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