Novo Nordisk Praises 'Remarkable' Weight Loss in Early Dual-Acting Oral Drug Trial

Novo Nordisk has recently unveiled promising results from a phase 1 trial of its new oral drug candidate, amycretin, which serves as an amylin and GLP-1 receptor co-agonist. This candidate has shown significant potential in weight loss treatments, having been linked to a 13.1% weight loss after 12 weeks of administration. The findings suggest that this drug could offer even greater benefits in longer-term studies.

Amycretin is designed to target both GLP-1, which is already addressed by drugs like Novo Nordisk's Ozempic, and amylin. Amylin plays a crucial role in glucose regulation and appetite control. By engaging both peptides, Novo Nordisk aims to enhance weight loss outcomes. This phase 1 study serves as an initial test to determine whether these benefits can be achieved with an oral formulation of the drug.

In March, Novo Nordisk revealed the headline finding of 13.1% weight loss after 12 weeks but held back the complete dataset for the European Association for the Study of Diabetes (EASD) conference. During the EASD event, the company disclosed that this 13.1% reduction was observed in individuals who took a 100 mg dose of amycretin daily. The results for those on a 50 mg dose and those on a placebo were 10.4% and 1.1% weight loss, respectively.

Agnes Gasiorek, Ph.D., a senior clinical pharmacology specialist at Novo Nordisk, described the results as "remarkable for an orally delivered biologic." She presented the data at EASD, noting that average weight continued to decrease in both amycretin groups between the eighth and twelfth weeks of the trial, with no apparent plateauing. However, Gasiorek cautioned that the short treatment duration and limited time at the final dose (only two weeks) might introduce bias, underlining the need for larger and longer studies to fully evaluate the effects of amycretin.

Further studies could help answer remaining questions about amycretin and its standing compared to other candidates being developed by companies like Eli Lilly, Pfizer, Roche, Terns Pharmaceuticals, and Viking Therapeutics. While predicting the ultimate success of these drugs is difficult due to the varying sizes of the trials and the complexities of cross-trial comparisons, Novo Nordisk's findings suggest that amycretin is competitive in terms of efficacy.

Despite its promising efficacy, tolerability remains a concern. High doses of amycretin led to gastrointestinal adverse events in 87.5% of participants, with 75% experiencing nausea and 56.3% experiencing vomiting. According to Gasiorek, the nausea cases were mostly mild to moderate, and those who vomited did so only once or twice.

Gastrointestinal issues are common among recipients of GLP-1 drugs, but there may be opportunities for differentiation based on tolerability. Viking Therapeutics, for instance, reported lower rates of adverse events in the initial phase of their dose escalation study.

Conclusively, while the early results for amycretin are promising, larger and longer studies are necessary to thoroughly assess its potential benefits and tolerability. These future studies will also help clarify how amycretin compares with other emerging candidates in the weight loss and glucose control market.

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