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Gan & Lee Pharmaceuticals has initiated a P-III (GRADUAL-3) study of bofanglutide (GZR18) in adults with obesity or overweight
The trial will assess the safety & efficacy of bofanglutide (SC, Q4W) in obese or overweight pts for 24wks., while evaluating the change and the percentage change from baseline in body weight at 24wk. as…
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The P-III (GLORY-2) trial assessed mazdutide (9mg) plus lifestyle intervention vs PBO in 462 Chinese adults with obesity (BMI ≥30kg/m²), incl. 16% with T2D, with an NDA submission to the NMPA planned in the near term
Trial met its 1EP, showing continuous weight loss with no plateau through Wk. 60, with pts achieving a…
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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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Aqua Medical has received the US FDA IDE approval to initiate the RESTORE-1 study evaluating the Proximal Intestinal Mucosal Ablation (PIMA) procedure using its radiofrequency vapor ablation (RFVA) system in adults with uncontrolled type 2 diabetes
The IDE approval was backed by international data showing safety & metabolic benefits of PIMA, allowing Aqua Medical…
Eli Lilly Reports Topline Data from P-III (ACHIEVE-2 & 5) Trials of Orforglipron for Type 2 Diabetes
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The 2 P-III (ACHIEVE-2 & 5) trials assessed orforglipron (3, 12 & 36mg; QD) vs dapagliflozin (10mg; QD) in 962 adults with T2D uncontrolled on metformin, & vs PBO in 546 adults with T2D uncontrolled on titrated insulin glargine ± metformin/SGLT2i for 40wks., respectively
ACHIEVE-2 showed reduced A1C (1EP) at Wk. 40 across both…
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The US FDA has accepted sBLA of Afrezza (insulin human) Inhalation Powder for the treatment of children & adolescents with type 1 or type 2 diabetes (PDUFA: May 29, 2026)
sBLA was supported by P-III (INHALE-1), assessing Afrezza vs multiple daily injections (MDI), both in addition to basal insulin among type1/2 diabetic pts (4-17yrs.)…
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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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Remedium Bio has entered into a multi-target research & development collaboration with Eli Lilly to develop gene therapies targeting multiple targets for the treatment of Obesity & Type 2 Diabetes, leveraging Remedium’s Prometheus platform
As per the deal, Remedium will receive an upfront, equity investment as well as development & commercial milestone payments, with tiered…
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Replicate has entered into a multi-year research collaboration with Novo Nordisk to develop novel self-replicating RNA (srRNA) therapies for obesity, T2D & other cardiometabolic diseases, leveraging Replicate’s srRNA platform
As per the deal, Novo & Replicate will collaborate on certain cardiometabolic targets, granting Novo an exclusive global license to Replicate’s srRNA platform to devlelop…
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Health Canada has approved Ozempic to reduce the risk of kidney disease worsening & CV death in adults with type 2 diabetes (T2D) & chronic kidney disease (CKD)
Approval was based on P-IIIb (FLOW) trial assessing Ozempic (1mg, Q1W, n=1767) vs PBO (n=1766) in type 2 diabetes & CKD pts (N=3533)
Study met its 1EP of 24% relative…

