CagriSema weight loss reached an estimated average of 12.4% in a late-stage trial involving adults with type 2 diabetes, according to Novo Nordisk.
The experimental weekly injection outperformed 5 mg tirzepatide, which produced an average weight loss of 9.1% in the same study.
The results came from the Phase 3 REIMAGINE 5 trial. Novo announced the findings during its Capital Markets Day on September 21.
CagriSema combines two active ingredients: cagrilintide and semaglutide. Semaglutide is also the active ingredient in Novo Nordisk’s widely used Wegovy and Ozempic medicines.
CagriSema Outperforms 5 mg Tirzepatide
In the trial, participants received either CagriSema at 1.0 mg/1.0 mg or tirzepatide at 5 mg.
After 60 weeks, participants taking CagriSema recorded an estimated average weight reduction of 12.4%.
The tirzepatide group recorded a 9.1% reduction.
Novo said CagriSema also produced a non-inferior reduction in HbA1c, a key measure of long-term blood sugar control. The reduction was 1.71% with CagriSema compared with 1.67% with tirzepatide.
Earlier Trial Was a Setback for Novo
The latest results come after a difficult result for Novo Nordisk earlier this year.
In February, CagriSema failed to meet the primary endpoint in the Phase 3 REDEFINE 4 trial against tirzepatide at the higher 15 mg dose.
CagriSema produced 23% weight loss after 84 weeks. However, it did not demonstrate non-inferiority to tirzepatide 15 mg.
That result raised questions about whether Novo could close the gap with Eli Lilly in the highly competitive obesity-drug market.
The new diabetes data provide a different result, although the doses and patient populations are not directly comparable with the earlier obesity trial.
CagriSema Also Shows Strong Obesity Results
Novo reported another positive result from the REDEFINE 9 trial.
In adults with overweight or obesity, CagriSema at 1.0 mg/1.0 mg produced a 21% weight reduction after 68 weeks, compared with 2% for placebo.
The company said the treatment was generally well tolerated in both trials, with a safety profile consistent with previous studies.
However, CagriSema remains an investigational treatment. The latest results do not mean the drug is already approved for routine use in these indications.
Novo Plans Next Steps for CagriSema
Novo Nordisk sees CagriSema as an important part of its next generation of obesity and diabetes treatments.
The company is developing the drug as a successor to its existing semaglutide-based products.
CagriSema combines semaglutide with cagrilintide, an amylin analogue designed to work through a different biological pathway.
Novo has also been expanding its pipeline as competition from Eli Lilly and other drugmakers intensifies.
FDA Decision Remains Important
Regulatory decisions will determine how quickly CagriSema can reach patients.
Novo Nordisk has already submitted CagriSema for weight-management approval in the United States. The company expects a U.S. Food and Drug Administration decision during the fourth quarter, according to its latest announcement.
Meanwhile, the company continues to study CagriSema in different patient groups.
The latest CagriSema weight loss results give Novo Nordisk additional data as it works to expand its next-generation treatment portfolio.
Still, the comparison with tirzepatide needs context because results can differ significantly depending on the dose, trial design and patient population.
