Novo CEO accepts ‘couple of setbacks’ in R&D as CagriSema posts more mixed data

Biotech Novo CEO accepts ‘couple of setbacks’ in R&D as CagriSema posts more mixed data By James Waldron Aug 5, 2026 8:00am Novo Nordisk failed trials CagriSema Obesity Novo Nordisk’s CEO admitted the Danish pharma has had “a couple of setbacks” in the wake of mixed data for CagriSema and its cardiovascular hopeful ziltivekimab, while stressing that the company is already on the hunt for bolt-on deals. The drugmaker’s blockbuster hopes for ziltivekimab, an antibody against the IL‑6 ligand, hit reality last week when the asset failed to demonstrate a significant reduction in major adverse cardiovascular events in a phase 3 study of patients with atherosclerotic cardiovascular disease, chronic kidney disease and inflammation. It leaves Novo pinning its hopes for the candidate on readouts next year for trials in people with heart failure or following an acute heart attack.

This morning, Novo also revealed that CagriSema—a combination of the amylin analog cagrilintide with the company’s well-known GLP-1 quantity semaglutide—missed one of the endpoints of a phase 3 study in patients with Type 2 diabetes. While the head-to-head study showed that CagriSema was non-inferior to tirzepatide—marketed by Eli Lilly as Mounjaro or Zepbound for diabetes or weight loss, respectively—when it came to weight loss, the trial failed to hit its other primary endpoint of matching the blood sugar control of Lilly’s blockbuster. When looking specifically at patients who adhered to their treatment regimen, CagriSema reported an average 15.2% weight loss at 68 weeks, compared to 15.8% for those on tirzepatide.

Meanwhile, the CagriSema cohort saw HbA1c reduction of 1.9 percentage points, compared to 2.2 percentage points for those on tirzepatide. The results came from the Reimagine-4 study. Novo recently announced top-line results from other studies in the Reimagine series, including the Reimagine-1 trial in patients with Type 2 diabetes—which showed a 1.8% reduction in HbA1c and average 13.8% weight loss at 40 weeks.

The latest readouts come after CagriSema was previously tied to 23% weight loss after 84 weeks of treatment in a phase 3 trial of patients without diabetes, while still struggling to hold its own against Lilly’s own next-gen metabolic hopeful, the triple agonist retatrutide. Regardless of whether CagriSema can demonstrate a clear lead over the competition, Novo has already submitted the candidate for FDA approval and is hopeful of launching next year. “CagriSema remains a highly efficacious medicine,” Novo CEO Mike Doustdar told journalists on a press call this morning.

“CagriSema creates a meaningful value versus the standard of care that exists today, and we will launch the product hopefully soon in [the] next year,” he added. “We will, of course, get into the details of the launch planning and the position of it as we get closer to that.” Referencing the failed ziltivekimab study, Doustdar acknowledged the company has had “a couple of setbacks recently on R&D.” “That's the nature of this industry,” he added. “Our hope, of course, is that for every one of those setbacks, we're able to demonstrate that we can progress multiple times more the innovations and bring them into the hands of the patients.” But while reaffirming that Novo has a “very robust pipeline and fantastic R&D,” Doustdar said the company “believes strongly that we need bolt-on acquisitions to complement what we are doing ourselves.” “As we're speaking to you, we have our staff looking into multiple different assets,” the CEO added.

Novo also used its earnings release to confirm that the company has finally dropped monlunabant—bringing to an end the company’s unsuccessful acquisition of Inversago Pharma in a $1.1 billion deal back in 2023. The Canadian biotech had been focused on drugs that block the cannabinoid CB1 receptor. The lead asset, monlunabant, failed a phase 2 diabetic kidney disease trial last year that included reports of mild to moderate neuropsychiatric side effects.

That safety data reawoke concerns about past CB1 blockers, with European authorities having withdrawn the approval of Sanofi’s own CB1 obesity drug back in 2009 after studies found it doubled the risk of psychiatric disorders. While monlunabant remained in Novo’s pipeline, the company would go on to scrap a next-generation CB1 receptor from Inversago later in 2025, although the molecule’s safety profile was not in doubt. Now, the Big Pharma has finally called time on the Inversago experiment.

“The Inversago acquisition didn't pan out as we hoped for, and now we've discontinued all activities that we got from that acquisition,” Novo’s Chief Financial Officer Karsten Munk Knudsen told Fierce on this morning’s call. “We had a hypothesis around an attractive risk-benefit balance for these assets,” the CFO added. “Unfortunately, what we saw was attractive efficacy on the compound, but the safety profile was not acceptable in this class of products.” Novo Nordisk failed trials CagriSema Obesity Type 2 diabetes Biotech