Response Pharmaceuticals’ drug has helped reduce the amount of weight a patient regains after treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs).
In the Phase II trial (NCT06640972), RDX-002 patients gained -2.92% weight after GLP-1RA discontinuation – a 34% relative difference compared to placebo.
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Further analysis also showed a difference in total body fat increase of 1.99% for RDX-002 compared to 6.71% for patients who received a placebo. The trial met its primary endpoint with a 51.9% reduction in blood-fat levels after eating.
The double-blind, placebo-controlled Phase II trial enrolled 68 patients in the US to investigate the efficacy and safety of the selective intestinal microsomal triglyceride transfer protein (iMTP) inhibitor over 12 weeks of treatment. An ongoing open-label extension (OLE) study will evaluate the benefit of 24 weeks of treatment.
Professor Chris Packard from the Institute of Cardiovascular and Medical Sciences at the University of Glasgow said: “GLP-1RAs have revolutionised obesity treatment, but they are not the end of the story.
“Many people regain weight and experience the return of an adverse cardiometabolic profile after stopping GLP-1RAs. A novel treatment that can sustain and build upon the gains achieved with GLP-1RAs presents a potentially important advance in long-term obesity care.”
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By GlobalDataResponse also has plans for studies evaluating RDX-002 in combination with GLP-1RAs to see if the drugs work synergistically in weight loss. Full data from the Phase II trial is set to be presented at an upcoming scientific meeting.
Response is developing the weight management drug under an exclusive worldwide licence from Sanofi.
Concerns around GLP-1RA
While GLP-1RAs have advanced the treatment of obesity, analysis shows that most patients discontinue treatment by 12 months, often due to cost or tolerability.
While weight regain is a concern, one of the major issues around the use of GLP-1RAs is the risk of muscle wastage; however, this impact is also seen with other weight loss treatments.
Scholar Rock is trying to help with this side effect, with the company launching a Phase II trial of its spinal muscular atrophy (SMA) monoclonal antibody (mAb) apitegromab alongside a GLP-1RAs in patients with obesity. The drug acts by inhibiting myostatin, a protein that limits muscle growth, thus potentially helping to increase muscle mass and strength. As a result, Scholar Rock hopes it could work as a complementary treatment to the flagship weight loss drugs.
Both Eli Lilly and Novo Nordisk remain toe to toe in the weight loss arena. Both recently announced developments of their oral GLP-1RA assets, and although Lilly may hold the crown for its subcutaneous offering, Novo Nordisk’s Phase III trial of oral semaglutide showed larger weight loss compared to Lilly’s orforglipron. Both companies are now seeking regulatory approval for their candidates.
Despite Lilly’s Phase III trial seemingly being overshadowed by Novo Nordisk’s, GlobalData analyst Jasper Morley said that the market scales still look like they will tip in Lilly’s favour.
Morley said: “Novo Nordisk’s oral semaglutide for obesity and Eli Lilly’s orforglipron calcium’s approvals would represent the first oral GLP-1RAs for obesity. While both products are expected to launch by 2026, orforglipron calcium is expected to reach blockbuster status first, in 2027, and generate $14.1bn in 2031. Meanwhile, oral semaglutide is expected to reach blockbuster status by 2029 and eventually generate $2.6bn in 2031.”
GlobalData is the parent company of Clinical Trials Arena.
