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Novo Nordisk's Cagrilintide/Semaglutide Combo Shows Superior Weight Loss in Phase III Trial

• A fixed-dose combination of cagrilintide and semaglutide led to greater weight loss at 68 weeks compared to either drug alone or placebo in the REDEFINE 1 trial. • The FDA expanded the indication for setmelanotide (Imcivree) to include children as young as 2 years with specific types of genetic obesity. • Palatin Technologies reported that 71% of patients with type 2 diabetic nephropathy achieved a significant reduction in urine protein in a phase IIb study with bremelanotide.

Novo Nordisk announced positive results from its phase III REDEFINE 1 trial, demonstrating that a once-weekly injection containing a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg (Wegovy) resulted in significantly greater weight loss at week 68 compared to either drug administered individually or placebo. This combination therapy highlights a potential advancement in obesity management.
The study's findings indicate a notable improvement in weight reduction compared to existing treatments. Cagrilintide is a novel amylin analogue, while semaglutide is a GLP-1 receptor agonist already approved for weight management and type 2 diabetes. The combination leverages the complementary mechanisms of both drugs to enhance efficacy.

Setmelanotide Label Expansion

The FDA has expanded the indication for setmelanotide (Imcivree), manufactured by Rhythm Pharmaceuticals, to include children as young as 2 years old who have syndromic or monogenic obesity due to Bardet-Biedl syndrome or genetically confirmed pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. This approval broadens the availability of targeted therapy for young children with specific genetic causes of obesity.

Bremelanotide Shows Promise in Diabetic Nephropathy

Palatin Technologies announced positive results from its phase IIb BREAKOUT study, where 71% of patients with type 2 diabetic nephropathy treated with bremelanotide achieved a greater than 30% reduction in urine protein to creatinine ratio at 6 months. Bremelanotide, a melanocortin receptor agonist, is being investigated for its potential to improve kidney function in patients with diabetic nephropathy. This suggests a possible new therapeutic avenue for addressing this complication of type 2 diabetes.
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Reference News

[1]
Imcivree Label Expanded; Weight Loss With Weekly Injection; Kidney Donation Chain
medpagetoday.com · Dec 24, 2024

FDA expanded setmelanotide use for children with obesity. Bremelanotide showed promise in diabetic nephropathy. USPSTF a...

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