With new CEO Maziar Mike Doustdar taking the helm, Novo Nordisk is looking to expand its obesity franchise, with an oral version of it blockbuster weight-loss drug, Wegovy (semaglutide). Will that be the key to expanding the fortunes of the company?

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

New leader at Novo Nordisk
Facing increased financial pressure in its key diabetes and obesity franchises, Novo Nordisk changed its top leadership, turning the company over to Maziar Mike Doustdar, formerly Novo Nordisk’s Executive Vice President of International Operations, as President and Chief Executive Officer, effective August 7, 2025. He succeeded Lars Fruergaard Jørgensen, who stepped down as President and CEO, also on August 7, 2025.

“This is an important moment for Novo Nordisk,” said Novo Nordisk Chair, Helge Lund, in a July 29, 2025, statement, in announcing the change in leadership. “The market is developing rapidly, and the company needs to address recent market challenges with speed and ambition. I believe Novo Nordisk will build on its strengths as a global leader in obesity and diabetes, and Mike has a clear vision of how to unlock the full potential of the opportunities ahead.”

Novo Nordisk first reported that Jørgensen would be stepping down in May (May 2025), citing a need for a change in executive leadership. The company faces increased competition from its blockbuster drugs, Ozempic/Wegovy (semaglutide), glucagon-like peptide 1 (GLP-1) agonists, respectively for treating Type 2 diabetes and obesity, potentially less than optimal results for its next-generation treatments, and experienced a sharp decline in the company’s stock prices earlier this year (2025), according to analysts.

Doustdar took on the role of President and CEO a day after the release of the company’s first-half (January-June 2025) results on August 6, 2025. While revenues increased overall, including in its key diabetes and obesity franchises, the company lowered its full-year 2025 revenue expectations. For the first half of 2025, sales within its key diabetes and obesity care segment increased by 16% in Danish kroner (DKK) (18% at constant exchange rates [CER]) to DKK 145.4 billion ($22.7 billion), mainly driven by obesity care growth of 56% (58% at CER) in Danish kroner to DKK 38.8 billion ($5.9 billion), and GLP-1 diabetes sales growing 8% in Danish kroner (10% at CER). In its other product area, rare disease, sales increased by 14% measured in Danish kroner (15% at CER).

In its first-half earnings report, the company lowered its 2025 financial outlook, projecting sales growth at 8-14% at CER, and operating profit growth expected to be 10-16% at CER. Sales and operating profit growth reported in Danish kroner are expected to be 3 and 5 percentage points lower than at CER, respectively. The lowered sales outlook for 2025 is driven by lower growth expectations for the second half of 2025, reflecting what the company called the “persistent” use of compounded GLP-1s, slower-than-expected market expansion, and competition. The outlook is related to lower growth expectations for Wegovy in the US obesity market, for Ozempic in the US GLP-1 diabetes market, as well as for Wegovy in select international markets. Novo Nordisk says it continues the global rollout of Wegovy, its key obesity drug, to more markets and invests in commercial activities toward driving market penetration for both Wegovy and Ozempic.  

Countering a slowdown
To counter that slowdown, Novo Nordisk highlighted key upcoming R&D milestones. It says it will advance subcutaneous and oral amycretin into Phase III development in weight management based on completed clinical studies during the first quarter of 2025. Amycretin is a long-acting GLP-1 and amylin receptor agonist under development for treating adults with overweight or obesity and for Type 2 diabetes.

The company is also advancing CagriSema, a fixed-dose combination of a long-acting amylin analogue, cagrilintide, and semaglutide, the active ingredient in Wegovy and Ozempic. CagriSema is being investigated by Novo Nordisk as a once-weekly subcutaneous injectable treatment for adults with overweight or obesity (REDEFINE program) and as a treatment for adults with Type 2 diabetes (REIMAGINE program). To boost its obesity franchise further, its REDEFINE clinical trials have been initiated to investigate further the potential efficacy and safety of CagriSema. Also, semaglutide 7.2 mg (a higher dose of Wegovy) has been submitted to regulatory authorities in the European Union.

The company is also advancing an oral version of its obesity drug, Wegovy. Novo Nordisk already has an oral version of semaglutide, the active ingredient in Ozempic and Wegovy, on the market in Rybelsus, which was first approved in 2019, but that is indicated for treating Type 2 diabetes, not obesity. In May (May 2025), Novo announced that the US Food and Drug Administration (FDA) accepted its new drug application (NDA) submission for an investigational once-daily oral formulation of Wegovy (semaglutide) for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions and to reduce the risk of major adverse cardiovascular events in adults with overweight or obesity and established cardiovascular disease. If approved, Wegovy would become the first oral formulation of a GLP-1 indicated for chronic weight management. The FDA action date to decide on the Wegovy oral formulation NDA is in the fourth quarter of 2025.

“We are entering a new era of obesity care where patients want individualized treatment plans that address their needs and provide choices, including oral formulations,” said Anna Windle, PhD, Senior Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk Inc, in a May 2, 2025, statement.  “… We are pleased that the FDA has accepted our submission and look forward to working with regulatory authorities on what would be the first oral GLP-1 treatment for obesity.”

Longer term, Novo Nordisk is further building its pipeline with oral obesity drugs. In June (June 2025), Novo inked a deal worth up to $815 million with Deep Apple Therapeutics, a South San Francisco-based company specializing in small-molecule drug discovery to discover, develop, and commercialize oral small-molecule therapeutics directed at a non-incretin G protein-coupled receptors (GPCR) target for cardiometabolic diseases, including obesity, in a deal worth up to $812 million.

In May (May 2025), Novo Nordisk and Septerna, a San Francisco, California-based bio/pharmaceutical company focused on GCPRs, formed an exclusive global collaboration and license agreement to discover, develop, and commercialize oral small-molecule medicines for treating obesity, Type 2 diabetes, and other cardiometabolic diseases, in a deal worth up to $2.2 billion ($200 million upfront and near-term funding and $2 billion in milestone payments). The companies will initially commence four development programs for potential small-molecule therapies directed to one or more select GPCR targets, including GLP-1, GIP, and glucagon receptors. The companies will jointly conduct research activities from discovery through development candidate selection. Starting at investigational new drug-enabling activities, Novo Nordisk will have sole responsibility for all global development and commercialization activities. In addition, Septerna has the right to opt in to a worldwide profit share for one program in the collaboration in lieu of future milestones and royalties for that product candidate.

Other competitors for oral GLPs
Novo is not alone in advancing oral GLP-1 agonists. Earlier this year (April 2025), Lilly reported positive Phase III results for orforglipron, an oral small-molecule (non-peptide) GLP-1 receptor agonist, for treating Type 2 diabetes and obesity. Orforglipron was discovered by Chugai Pharmaceutical and licensed by Lilly in 2018. Chugai and Lilly published the preclinical pharmacology data of this molecule together, and Lilly is running Phase III studies on orforglipron for the treatment of Type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea and hypertension in adults with obesity.

Roche is advancing an oral GLP-1 receptor agonist, CT-996, which it gained through its 2024 acquisition of  Carmot Therapeutics, a Berkeley, California-based bio/pharmaceutical company, in a deal worth up to $3.1 billion ($2.7 billion at closing plus $400 million in potential milestone payments). The acquisition provided Roche with three clinical-stage assets with potential in treating obesity and diabetes. These included CT-996, a once-daily oral small-molecule oral GLP-1 receptor agonist, in Phase I, for treating obesity in patients with and without Type 2 diabetes, as well as two injectable clinical drug candidates: CT-388, a once-weekly subcutaneous injectable in Phase II, for treating obesity in patients with and without Type 2 diabetes, and CT-868, a once-daily subcutaneous injectable, in Phase II, for treating Type 1 diabetes patients with overweight or obesity.

Oral GLP-1s for obesity saw a recent setback when in April (April 2025), Pfizer announced that it was discontinuing development of danuglipron, an oral GLP-1 receptor agonist, which was being investigated for chronic weight management, due to potential liver toxicity. Pfizer reported that its dose-optimization studies of once-daily formulations of danuglipron met key pharmacokinetic objectives and confirmed a formulation and dose with the potential to deliver a competitive efficacy and tolerability profile in Phase III testing, based on earlier studies of twice-daily danuglipron. Pfizer reported that while the overall frequency of liver enzyme elevations across the over 1,400 participant safety database of danuglipron was in line with approved agents in the class, a single asymptomatic participant in one of the dose-optimization studies experienced potential drug-induced liver injury that resolved after discontinuation of danuglipron. After a review of the totality of information, including all clinical data generated to date for danuglipron and recent input from regulators, Pfizer decided to discontinue development of the molecule.

Viking Therapeutics, a San Diego, California-based clinical-stage bio/pharmaceutical company, is advancing a dual GLP-1/GIP agonist, VK2735, for treating obesity for both subcutaneous and oral administration. The oral formulation is in Phase II development, and the subcutaneous formulation is planned for Phase III testing in 2025. In March (March 2025), Viking Therapeutics signed a multi-year contract with the CDMO CordenPharma to provide development and manufacturing services for clinical and commercial scale (drug substance and drug product) of VK2735 for both the subcutaneous and oral peptide formulations.