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The U.S. FDA has accepted the NDA for Novo's CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg) to support long-term weight loss & maintenance in adults with obesity or overweight & ≥1 related comorbidity, alongside lifestyle intervention
NDA was supported by the P-III (REDEFINE 1) trial assessing CagriSema (QW) vs semaglutide 2.4mg alone, cagrilintide 2.4mg alone,…
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Trial assessed Lilly’s retatrutide (9 & 12mg) + lifestyle intervention in adults with obesity or overweight & knee osteoarthritis, & without diabetes, meeting its co-1EPs with 26.4% (9mg) & 28.7% (12mg) vs 2.1% weight loss & reduced WOMAC pain by 4.5 & 4.4 vs 2.4 points
It also reduced known CV risk markers &…
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Pfizer has entered into an exclusive global collaboration & license agreement with YaoPharma for YP05002, a GLP-1 receptor agonist for chronic weight management
As per the deal, YaoPharma will complete the ongoing P-I trial of YP05002 & grant Pfizer exclusive global rights for further development, manufacturing & commercialization, receiving $150M upfront & ~$1.935B in…
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The post hoc analysis of P-III (REDEFINE 1) trial assessed CagriSema (cagrilintide 2.4mg & semaglutide 2.4mg) vs PBO & individual components effects on CV risk factors in 3,417 obese/overweight pts with ≥1 obesity-related comorbidities, & without T2D
Trial showed CagriSema reduced systolic BP by -10.9 mmHg over 68wks. (vs -8.8 with semaglutide, & -2.1 with PBO),…
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Novo Nordisk has reported a sub-analysis of P-III (REDEFINE 1) trial assessing cagrilintide monotx. (2.4mg) with lifestyle intervention vs PBO in 3,417 obese/overweight pts with ≥1 obesity-related comorbidities, & without type 2 diabetes
Trial showed 11.8% superior weight loss vs 2.3% after 68wks., while 31.6% lost ≥15% of body weight vs 4.7%. However, weight…
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Ascletis Pharma has dosed first participants with ASC30 (PO, QD) in its US P-IIa trial for obesity (BMI ≥30kg/m^2) or overweight pts (BMI ≥27kg/m^2 but <30kg/m^2) with ≥1 weight-related comorbidity
Trial will assess 2 ASC30 formulations (tablets & tablets A1), with pts starting at 1mg & undergoing weekly titrations to maintenance doses of 20 or 40mg…
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The P-Ib/IIa trial assessed amycretin (Q1W) vs PBO in overweight or obese patients (n=125) in 5 parts
Part A (single ascending dose) assessed PK & determined the initial dose for Part B (multiple dose arm), which evaluated safety/tolerability over 36wks. Parts C, D, & E (PoC) evaluated weight loss with 3 doses (1.25mg,…

