Promising Clinical Trial Results
Novo Nordisk announced on Sunday that an advanced trial of its drug, semaglutide, when administered orally in high doses, helped overweight and obese individuals lose 15% of their body weight. This promising outcome aligns with similar results obtained by other experimental obesity drugs currently under investigation.
Regulatory Approval and Market Launch
The company plans to request U.S. and European regulatory approval for the high-dose pill later this year. The schedule for its market debut, however, remains undetermined, according to Mico Guevarra, Novo Nordisk's medical director.
Addressing Supply Issues and Increasing Demand
The Denmark-based company has faced supply difficulties in meeting the surging demand in the U.S. for Wegovy and Ozempic, the brand names under which semaglutide is sold as a weekly injection for treating obesity and diabetes. Guevarra assured that production is being ramped up to accommodate the rising demand.
Weight-Loss Treatment Market Outlook
The semaglutide drug, designed to regulate blood sugar, slow stomach emptying, and reduce appetite, belongs to a novel class of drugs that has sparked renewed interest among researchers and investors in the weight-loss treatment market. The market size is projected to reach $100 billion by the end of the decade.
More Details about the Trial
The advanced trial involved 667 overweight and obese adults and tested a dose of 50mg of semaglutide. This resulted in an average weight loss of 15.1% after 68 weeks when complemented with a healthy diet and physical activity. This weight loss was significantly greater compared to the 2.4% observed in the placebo group.
Use and Restrictions of Oral Semaglutide
The FDA's guidelines for oral semaglutide stipulate that the pill should be taken on an empty stomach in the morning, 30 minutes before eating, drinking, or taking other oral medications. Eating too soon after taking the pill could decrease its effectiveness, but waiting longer may enhance absorption.
Alternative Obesity Treatments
Other pharmaceutical companies are working on obesity drugs without such dietary restrictions, which could be more appealing to patients reluctant to self-administer weekly injections.
Side Effects Noted in the Trial
Most patients in Novo Nordisk's trial reported gastrointestinal side effects from oral semaglutide, including mild-to-moderate nausea, constipation, diarrhea, and vomiting. Approximately 13% of patients experienced "altered skin sensation," which typically resolved after several weeks.
Additional Results and Publications
Results from a separate late-stage trial showed that daily oral semaglutide, at doses of up to 50mg, helped patients with type 2 diabetes reduce their blood sugar levels by up to 2 percentage points. The findings from both Novo trials were published in the reputable Lancet medical journal.
