Novo Nordisk will bring 35 presentations to EASD 2025 in Vienna, spanning late- and early-stage evidence across its semaglutide franchise and next-generation obesity candidates. The slate includes real-world comparative effectiveness suggesting Ozempic outperforms dulaglutide on cardiovascular events in US Medicare beneficiaries, outcomes data on oral semaglutide from SOUL, analyses of semaglutide’s impact in obesity and cardiometabolic comorbidities, and updates on pipeline assets CagriSema, cagrilintide monotherapy, and the unimolecular GLP-1/amylin agonist amycretin. Additional readouts touch metabolic-associated steatohepatitis and patient-reported “food noise,” and Novo will reinforce the narrative with a same-week R&D investor event.
The strategy is clear: shift the GLP-1 conversation from weight loss to total cardiometabolic risk reduction, and do it with a mix of randomized outcomes and decision-grade real-world data. With payers scrutinizing obesity budgets and diabetes line-item costs, evidence on cardiovascular events, hospitalizations, and functional outcomes is the currency that moves access. Real-world head-to-heads—positioned as the first of their kind—aim to reframe within-class dynamics against dulaglutide and, by extension, challenge competing incretin portfolios. The provocation is whether comparative effectiveness outside trials will be enough to reset step edits, preferred tiers, and prior authorization criteria across the US and EU markets.
Timing matters. For patients, consistent signals of cardiovascular protection across formulations and populations could accelerate earlier initiation in type 2 diabetes with atherosclerotic disease and in obesity with elevated CV risk. For HCPs, nuanced dosing and regimen choices—ranging from once-weekly semaglutide at higher doses to combination strategies with cagrilintide—raise practical questions about sequencing, tolerability, and adherence. Payers now confront a growing body of evidence that these agents touch hard outcomes, not just weight, opening the door to outcomes-based contracts tied to cardiovascular event reduction and hospitalization rates. Health systems and self-insured employers will evaluate whether total cost-of-care offsets justify broader eligibility and fewer utilization controls as supply scales.
The broader trend line is an arms race beyond first-generation GLP-1s. Amylin pharmacology is re-emerging as a meaningful lever, with cagrilintide monotherapy data poised to inform standalone value and CagriSema testing the ceiling of combination efficacy. Amycretin, if it delivers GLP-1 and amylin activity in a single molecule with favorable tolerability and manufacturability, could simplify dosing and reduce complexity versus co-formulations—an advantage in a market where capacity and reliability are competitive assets. Meanwhile, the pivot to real-world head-to-heads signals a new competitive arena: when traditional CVOTs are costly and slow, companies will prosecute share battles through RWE designed to resonate with P&T committees and guideline bodies.
What to watch next is the translation. Do SOUL and the RWE cardiovascular findings catalyze label expansions, guideline updates, and payer policy shifts in the next review cycles, particularly for obesity populations without diabetes? Does evidence presented on hospitalizations, body composition, and control of eating strengthen the case for earlier-line use or removal of behavioral therapy prerequisites? And can Novo Nordisk manage portfolio sequencing—cagrilintide, CagriSema, amycretin—without cannibalizing margins or overcomplicating supply and patient journeys? The competitive question is whether this evidence cadence can lock in formulary primacy before multi-agonist entrants narrow efficacy gaps, making real-world superiority the decisive differentiator in cardiometabolic care.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
