Novo Nordisk has announced promising results from a small Phase 1 clinical trial of its experimental obesity pill amycretin, which demonstrated a 13% reduction in body weight after just 12 weeks of treatment. The findings, presented at the 60th annual meeting of the European Association for the Study of Diabetes in Madrid, suggest the oral medication could potentially outperform the company's own injectable weight loss drug Wegovy.
The trial involved 144 participants, with results specifically reported from a cohort of 16 individuals who received an unspecified dose of the medication. Participants who received a placebo lost approximately 1% of their body weight during the same period, resulting in a placebo-adjusted weight loss of about 12%.
Novel Dual-Action Mechanism
Amycretin represents a new approach to weight management by simultaneously targeting two gut hormones - glucagon-like peptide-1 (GLP-1) and amylin - both of which play crucial roles in regulating appetite and blood sugar levels. This dual-action mechanism differs from Novo Nordisk's current blockbuster Wegovy, which primarily targets GLP-1 receptors.
"The pharmacokinetic profile of amycretin allows for further development and we look forward to progressing it through larger clinical trials in the coming years," Novo Nordisk stated.
The company reported that adverse events were similar to those observed with other GLP-1 medications in its portfolio, suggesting a comparable safety profile to established treatments.
Potential Game-Changer in Obesity Treatment
If successful in larger trials, amycretin could represent a significant advancement in obesity treatment. Current GLP-1 medications like Wegovy and Eli Lilly's Zepbound require weekly injections, which can be a barrier for some patients.
"Having a pill available that is just as effective — or more effective — would certainly make using these medications easier for the patient," noted Dr. Mir Ali, a bariatric surgeon not involved in the research.
The early results appear particularly impressive when compared to existing treatments. Neither Wegovy nor Zepbound achieved more than 10% weight loss after 12 weeks in their pivotal trials. Even Novo's newer injectable combination therapy CagriSema required 20 weeks to help patients lose 17% of their body weight.
Competitive Landscape and Market Implications
The announcement comes at a critical time as Novo Nordisk faces increasing competition in the rapidly expanding obesity treatment market. Wall Street analysts at Leerink Partners forecast the sector could reach $158 billion in annual sales by 2032.
Eli Lilly has already secured approval for Zepbound and is advancing an oral weight loss medication currently in Phase 3 testing. Other companies including Viking Therapeutics and Structure Therapeutics are also developing competing treatments.
The news of amycretin's promising results caused Novo Nordisk's stock to surge 8% in Denmark trading, while shares of competitor Viking Therapeutics, which is also developing an oral weight-loss medicine, fell more than 17%.
Manufacturing Challenges Ahead
Despite the promising clinical results, analysts have raised concerns about potential manufacturing limitations. ISI Evercore analyst Umer Raffat noted that high doses of amycretin would require as much as 1 billion milligrams weekly to meet U.S. market demand alone—far exceeding Novo's current production capacity.
This manufacturing challenge could potentially limit the drug's market impact even if it receives regulatory approval in the coming years.
Next Steps in Clinical Development
While the Phase 1 results are encouraging, the drug must still progress through the standard clinical development pathway. Phase 2 trials will evaluate effectiveness and safety in a larger cohort of 100-300 participants, followed by Phase 3 trials involving 1,000-3,000 individuals to confirm initial findings.
Dr. Shiara Ortiz-Pujols, an obesity medicine physician not involved in the research, cautioned: "The data are exciting, but do not tell us how this medicine works in diverse populations, in people with different conditions, nor does it give us information on the long-term effects on a person's health."
Future clinical trials will likely examine several critical factors, including gastrointestinal tolerability, potential weight regain after discontinuation, and possible cardiovascular or hepatic benefits compared to existing treatments.
The full results from the trial have not yet been published in a peer-reviewed journal, and the company has not announced a timeline for initiating the next phase of clinical testing.
