Denmark's Novo Nordisk is launching phase 3 trials in Korea for "CagriSema," a next-generation obesity treatment in development following Wegovy. Novo is pursuing development with an eye to a global launch, including Korea among the trial countries.
On the 28th, according to the industry, Novo on the 26th won approval from the Ministery of Food and Drug Safety for an investigational new drug (IND) application for a phase 3 trial to evaluate the efficacy and safety of CagriSema in overweight or obese Asian adults.
This phase 3 will enroll about 400 overweight or obese adults in Asia. According to global clinical trial registry information, the primary endpoint is the percentage change in body weight at week 80.
In Korea, Kyungpook National University Hospital, Pusan National University Yangsan Hospital, Konkuk University Medical Center, Ajou University Hospital, Seoul National University Bundang Hospital, Yonsei University College of Medicine Severance Hospital, and Seoul National University Hospital will take part in the trial.
CagriSema is Novo's next-generation candidate for obesity and diabetes that was previously called "amylcretin." It is a dual agonist that simultaneously stimulates the glucagon-like peptide (GLP)-1 and amylin receptors with a single peptide molecule. Novo is developing not only a once-weekly subcutaneous (SC) injection but also an oral formulation.
CagriSema previously showed weight-loss potential in phase 2. According to phase 2 results Novo presented in June at the American Diabetes Association (ADA), in a 36-week study of 262 patients with type 2 diabetes, those who received the highest once-weekly subcutaneous dose of 40 mg saw a mean weight reduction of 14.6%. The placebo group's weight reduction rate was 2.1%.
Glycated hemoglobin (HbA1c), a marker of blood sugar control, decreased by 1.71 percentage points. The most common adverse reactions were gastrointestinal symptoms, which were mostly mild to moderate.
However, it is difficult to directly compare these results with currently marketed obesity treatments, because the trial populations, duration, and designs differ.
In fact, Novo's Wegovy recorded an average 14.9% weight reduction over 68 weeks in a phase 3 trial of overweight or obese patients without diabetes. The competing product "Mounjaro" from Eli Lilly and Company showed an average 20.9% weight reduction over 72 weeks at the highest dose of 15 mg in a phase 3 trial under the same patient conditions.
CagriSema showed a 14.6% weight reduction in patients with type 2 diabetes over a shorter 36-week period. In general, patients with type 2 diabetes tend to have smaller weight reductions than obese patients without diabetes.
Ultimately, the key question for this phase 3 is whether CagriSema can demonstrate a meaningful weight-loss effect in actual patients with obesity. In particular, attention is on whether long-term data over 80 weeks can show differences in weight-loss efficacy compared with existing GLP-1 therapies.
In Korea, beyond this global phase 3, a cardiovascular study of CagriSema is also underway with approval from the Ministery of Food and Drug Safety.