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Lilly's P-III trial assessed orforglipron vs PBO in maintaining weight loss in 376 adults with obesity/overweight & weight-related comorbidities who previously completed the initial treatment with Wegovy/Zepbound in the SURMOUNT-5 trial; NDA was submitted to FDA & received a US FDA’s CNPV
Trial met its 1EP in SURMOUNT-5 pts at a weight plateau, showing superior…
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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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Ascletis Pharma has selected ASC37 tablets (PO), a GLP-1R/GIPR/GCGR triple peptide agonist, as a clinical development candidate
ASC37, utilizing Ascletis’ POTENT tech, showed an average of 4.2% absolute oral bioavailability, higher than semaglutide, tirzepatide, & retatrutide in oral SNAC formulations, & ~57-fold greater AUC vs retatrutide (PO) in NHP studies, with an observed t½ of…
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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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Nitinotes has received CE Mark approval for its EndoZip System for endoscopic sleeve gastroplasty (ESG)
EndoZip automates suturing, transforming ESG into a single-physician, scalable, fast outpatient procedure with improved efficiency & reproducibility compared to manual systems requiring dual operators & longer procedure times
The company has planned to launch EndoZip in select EU centers &…
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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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Metsera has declared Novo Nordisk’s unsolicited ~$9B acquisition proposal, valuing shares up to $77.75, as a “Superior Company Proposal” than its existing Pfizer Merger Agreement
The 2-step proposal incl. an initial $56.5/share cash payment & issuance of non-voting preferred stock for 50% of Metsera’s share capital, followed by a CVR of ~$21.25/share in cash…
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…

