Novo Nordisk has initiated Phase 3 clinical trials for its next-generation obesity treatment candidate, ZenaGamtide, in South Korea. The company is ramping up efforts to develop a successor to Wegovy (semaglutide) as it engages in fierce competition with Eli Lilly in the global obesity drug market.
Industry sources reported on Friday that Novo received approval from the Ministry of Food and Drug Safety on Wednesday to conduct Phase 3 trials evaluating the efficacy and safety of ZenaGamtide in overweight or obese Asian individuals.
The AMAZE 13 trial will involve approximately 400 overweight and obese adults across Asia. According to global clinical trial registries, the primary endpoint will measure weight change percentages at the 80-week mark.
In South Korea, the trials will be conducted at several prestigious institutions, including Kyungpook National University Hospital, Yangsan Busan National University Hospital, Konkuk University Hospital, Ajou University Hospital, Bundang Seoul National University Hospital, Yonsei University Severance Hospital, and Seoul National University Hospital.
ZenaGamtide, formerly known as Amicretin, is Novo’s next-generation candidate for treating obesity and diabetes. This innovative dual-action peptide simultaneously stimulates both GLP-1 and amylin receptors. The company is currently developing both weekly subcutaneous injections and oral formulations.
GLP-1, a hormone that suppresses appetite and enhances satiety, is the primary target for existing obesity treatments like Wegovy. Amylin also plays a role in reducing food intake and increasing feelings of fullness. ZenaGamtide aims to enhance weight loss effects by targeting both pathways with a single molecule.
Phase 2 trials have shown promising results for weight loss. Data presented by Novo at the American Diabetes Association (ADA) conference in June revealed that the highest dose group (40 mg of subcutaneous ZenaGamtide) achieved an average weight reduction of 14.6% over 36 weeks in a trial involving 262 patients with type 2 diabetes. In contrast, the placebo group saw a modest 2.1% reduction.
The 40 mg group also experienced a significant decrease in hemoglobin A1c (HbA1c) levels. The most common side effects were gastrointestinal symptoms, which were predominantly mild to moderate in severity.
However, experts caution against direct comparisons between ZenaGamtide’s Phase 2 results and those of currently marketed obesity treatments, citing differences in patient populations, trial durations, and study designs.
For context, Wegovy demonstrated an average weight reduction of 14.9% over 68 weeks in the STEP 1 Phase 3 trial involving overweight and obese patients without diabetes. Eli Lilly’s Tirzepatide achieved an impressive 20.9% average weight reduction over 72 weeks at its highest dose (15 mg) in the SURMOUNT-1 Phase 3 trial for overweight and obese patients without diabetes.
ZenaGamtide’s 14.6% weight reduction in type 2 diabetes patients over just 36 weeks is particularly noteworthy. Typically, patients with type 2 diabetes tend to lose less weight compared to obese individuals without diabetes.
However, the medical community eagerly awaits results from later-stage trials to confirm whether ZenaGamtide will maintain similar weight loss effects in a broader obese population. This underscores the importance of the AMAZE 13 trial and other Phase 3 programs.
Novo has officially launched its comprehensive Phase 3 clinical trial program for ZenaGamtide this year. The subcutaneous injection formulation is being tested not only in obese patients but also in those with obesity-related comorbidities such as type 2 diabetes, obstructive sleep apnea, and knee osteoarthritis. Additionally, the company is advancing a Phase 3 trial to evaluate the weight loss efficacy of an oral ZenaGamtide formulation.