Press release | 17th Apr 2024

The latest STEP in expanding the legacy of semaglutide – STEP HFpEF-DM results from ACC 2024

The rise of the GLP-1s in the cardiometabolic arena

The meteoric rise of glucagon-like peptide 1 ( GLP-1) receptor agonists has taken the pharmaceutical world by storm, with the prediction that GLP-1’s will soon surpass cancer immunotherapies as the highest-grossing drug class worldwide. The explosive growth of GLP-1 agents has been driven largely by label expansions from their original indication in Type 2 Diabetes (T2D) to more recent approvals supporting use as anti-obesity medications. Novo Nordisk’s injectable GLP-1 receptor agonist, semaglutide is one that has stolen the spotlight. Originally marketed as Ozempic for T2D (and now as Wegovy for obesity), the drug’s viral fame on social media has uniquely allowed for it to transcend the pharmaceutical industry entirely, having recently inspired its own dedicated skit on a March 2024 episode of Saturday Night Live. More quietly, perhaps, Novo Nordisk is continuing efforts to expand the legacy of semaglutide by pursuing additional cardiovascular label expansions. At #ACC24, Novo Nordisk presented results of the STEP HFpEF-DM study, which aims to position semaglutide as a cutting-edge therapy for obese, diabetic patients with heart failure.

Wegovy: more than just for weight loss

STEP HFpEF-DM is Novo Nordisk’s latest pivotal trial in the STEP series of clinical studies for Wegovy, and full results from the study were presented at #ACC24. The data showed that once-weekly subcutaneous semaglutide was superior to placebo for driving reductions in body weight and patient-oriented quality-of-life improvements after 52 weeks of treatment. Of note, diabetic patients typically experience smaller reductions in body weight on GLP-1 therapy compared to non-diabetic patients, and correspondingly, Wegovy-treated patients in STEP HFpEF-DM lost approximately half as much weight compared to their non-diabetic counterparts in Novo Nordisk’s sister study, STEP HFpEF. Despite the difference, improvements in heart failure symptoms and physical limitations were largely similar for patients receiving Wegovy in both studies. Together, data from the twin studies adds to the body of evidence that Wegovy may provide disease-modifying effects that are independent of weight loss. Novo Nordisk submitted US and EU regulatory filings to support heart failure label expansions for Wegovy in January of this year, supported by results of both studies.

The war between the GLP-1s to tackle obesity

With competition in the GLP-1 space ramping up following the US launch of Eli Lilly’s tirzepatide (dual receptor agonist for GLP-1 and glucose-dependent insulinotropic polypeptide) for obesity in December 2023, Novo Nordisk is hoping that its cardiovascular aspirations for Wegovy will keep the company several strides ahead of the competition. Indeed, Novo Nordisk took a significant step forward in establishing a foothold for Wegovy in the cardiovascular space already in March this year, with FDA approval for the pivotal SELECT study of Wegovy. Wegovy may now be prescribed for reducing the risk of major cardiovascular adverse events to overweight patients with cardiovascular disease. The approval marked a major turning point for the drug’s reimbursement, as the new indication allowed Novo Nordisk to side-step the existing ban on Medicare coverage for anti-obesity medications. If approved for heart failure, Novo Nordisk can expect to see additional pressure for private providers to include Wegovy on their formularies.

Evolution to treat the cardiometabolic space holistically

The push to secure cardiovascular indications for GLP-1 agents exists as a part of a larger trend for competitors in the cardiometabolic space to address common obesity-related comorbidities. Both Novo Nordisk and Eli Lilly have numerous studies exploring this paradigm, including FLOW (semaglutide for chronic kidney disease) and SURMOUNT-OSA (tirzepatide for obstructive sleep apnea), among others. Moving forward, with the reimbursement landscape continuing to evolve, major players in the obesity market are now contending with the notion that GLP-1 therapy may be a life-long commitment for patients; Eli Lilly has initiated the SURMOUNT-MAINTAIN study to explore maintenance dosing for Zepbound (tirzepatide). As Novo Nordisk and Eli Lilly prepare their next-generation of anti-obesity medications in ongoing Phase 3 trials, additional competitors such as Amgen, Pfizer, Boehringer Ingelheim, Viking Therapeutics, Structure Therapeutics, and Zealand Pharma are hoping to enter the market in the coming years.

Upcoming medical conferences

Where to meet us

Publications and Resources Access

Sign up to download our publications, gain access to our comprehensive list of medical conferences and national holidays calendar.

View our resources
Offices
  • London, UK
  • Toronto, CA
  • Vancouver, CA
  • Boston, US
  • New York, US
  • San Francisco, US
Contact
Stay in touch
  • YouTube
  • Twitter
  • Linkedin
  • Instagram