RDX-002 / Response Pharma - LARVOL DELTA

Response Pharmaceuticals Reports Positive 36-Week Phase 2 Data Supporting RDX-002 as a Long-Term Option in Post-GLP-1 Receptor Agonist Weight Management (Businesswire) - "The 36-week Phase 2 study enrolled 68 participants after their planned discontinuation of GLP-1 RA treatment for weight management....Met primary endpoint of reduction of postprandial triglyceride response to a standardized high fat meal (AUC: –93.5% vs. placebo (p<0.001) at Week 12). After stopping GLP-1 RA therapy, subjects on RDX-002 preserved 57% of prior GLP-1–associated weight loss at Week 36. Subjects who switched from placebo to RDX-002 for the OLE portion of the study also saw significant reductions in the rate of weight regain: 0.58% per week lowered to 0.14% per week after cross-over."

P2 data • Obesity

Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists (clinicaltrials.gov) - P2 | N=68 | Completed | Sponsor: Response Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Reduced Weight Gain With an MTP-Inhibitor in Patients Stopping GLP-1 Agonist Therapy for Obesity (OBESITY WEEK 2025) - "Discontinuation of GLP-1 agonists result in rapid body weight regain that appears to be partially driven by an increase in pp TGs. Treatment with RDX-002 greatly reduced postprandial TGs in these patients, significantly blunted body weight regain and was well-tolerated."

Clinical • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Response Pharmaceuticals Announces Positive Top-Line Results From Phase 2 Study of RDX-002 in Post-GLP-1 Management (GlobeNewswire) - "Mean reduction of –227.3 mg*hr/dL in postprandial triglycerides (area under the response curve) at Week 12 versus placebo change of +64.1 mg*hr/ml (LS mean difference of -93.5%; p<0.001); Individuals receiving RDX-002 gained less weight after GLP-1 discontinuation: -2.92% (-34% relative difference) versus placebo (p=0.019); exploratory analyses also suggest a corresponding difference in total body fat mass change (mean percent change at week 12 of 1.99% for RDX-002 vs. 6.71% for placebo)....Full data from this Phase 2 study will be presented at an upcoming scientific meeting. Response Pharmaceuticals plans to further evaluate the safety and efficacy of RDX-002 for the treatment of AIWG, and other weight management indications."

P2 data • Obesity

Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists (clinicaltrials.gov) - P2 | N=68 | Active, not recruiting | Sponsor: Response Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=40 ➔ 68

Enrollment change • Enrollment closed • Genetic Disorders • Obesity

Response Pharmaceuticals Announces Early Completion of Enrollment of a Phase 2 Study Evaluating RDX-002 Treating Patients Discontinuing GLP-1 Agonists (Businesswire) - "Response Pharmaceuticals, Inc...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...'We look forward to reporting data from this study at the end of the second quarter of 2025'..."

Enrollment closed • P2 data • Obesity

A Pilot Study of the Intestinal MTP-Inhibitor, RDX-002, in Antipsychotic-Induced Weight Gain (AIWG) (OBESITY WEEK 2024) - "This study was to determine if RDX-002 reduced the uptake of dietary fat and body weight in subjects receiving the AAP, olanzapine (OLAN). This is the first clinical evidence for a role for iMTP and increased pp TGs in AIWG. Treatment with RDX-002 significantly reduced ppTGs and blunted body weight gain in OLAN-treated subjects indicating a potential role in the prevention of AIWG. RDX-002 was generally well-tolerated."

Clinical • Bipolar Disorder • Cardiovascular • CNS Disorders • Diabetes • Dyslipidemia • Metabolic Disorders • Mood Disorders • Psychiatry • Schizophrenia

Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Response Pharmaceuticals

New P2 trial • Genetic Disorders • Obesity

Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With Olanzapine (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Response Pharmaceuticals | Not yet recruiting ➔ Completed

Trial completion • CNS Disorders • APOB

Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With Olanzapine (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Response Pharmaceuticals

New P1 trial • CNS Disorders • APOB