Drug companies planning to seek approval for over-the-counter weight loss medications
Orforglipron, a new oral GLP-1 receptor agonist developed by Eli Lilly, is making waves in the weight loss industry. The drug, which is set to be applied for FDA approval by the end of the year, has shown substantial weight loss results and improvements in metabolic health markers.
Weight Loss Benefits
In the highest dosage of Orforglipron, participants lost an average of 12.4 percent of their weight after 72 weeks. This substantial weight loss is comparable to injectable drugs like Wegovy (semaglutide) and Zepbound (tirzepatide), although it may be slightly less potent.
Orforglipron also offers benefits in reducing blood sugar and A1c levels in type 2 diabetes patients, comparable to injectable drugs like Ozempic.
Side Effects
The side effect profile of Orforglipron is similar to injectable GLP-1 receptor agonists, with mostly gastrointestinal symptoms such as diarrhea, nausea, constipation, abdominal pain, and vomiting. However, vomiting appears to be less frequent compared to semaglutide.
Potential Advantages
One of the significant advantages of Orforglipron is its oral administration, which may be more convenient and preferable compared to injectable drugs. Additionally, it may be less costly and easier to manufacture, potentially increasing accessibility.
Expert Opinions
Dr. David Cummings from the University of Washington believes that Orforglipron may not be as potent as injectable drugs like Wegovy or Zepbound but emphasizes that its oral formulation and potentially lower cost could make it "truly impactful" in obesity treatment.
Eli Lilly is confident in the drug’s efficacy and safety, planning to seek FDA approval for obesity treatment by late 2025. Experts await peer-reviewed publication and official regulatory review but note that Orforglipron’s profile is reassuring given the similar side effect pattern and substantial weight loss.
Comparison with Existing Medications
| Feature | Orforglipron (oral GLP-1) | Wegovy (injectable semaglutide) | Zepbound (injectable tirzepatide) | |----------------------|-----------------------------------|----------------------------------|----------------------------------| | Weight loss | ~12.4% (27 lbs after 72 weeks) | ~13.2% after 72 weeks | ~20.2% weight loss in prior trial | | Administration | Oral daily pill | Weekly injection | Weekly injection | | Side effects | GI symptoms (diarrhea, nausea) | GI symptoms (vomiting, nausea) | GI symptoms | | Potency | Slightly less than injectables | High | Higher | | Advantages | Oral dosing, possible lower cost | Proven efficacy, widely used | Dual hormone targeting, strongest effects |
While Orforglipron offers a promising alternative to injectable GLP-1 agonists, some experts have expressed caution. Stephan Martin, a chief physician for diabetology, states that the new pill may not be a "breakthrough" in obesity treatment.
Meanwhile, Stefan Kabisch, a metabolism researcher, criticizes the study for only comparing the weight loss pill with a placebo, noting that highly effective nutritional therapies can achieve similar results.
Despite these concerns, the demand for weight loss injections like Wegovy is huge, and a weight loss pill could also hit the market next year. The potential benefits of Orforglipron, including its oral administration and possible cost advantages, could significantly improve treatment accessibility and patient adherence.
[1] Eli Lilly and Company. (2022). Orforglipron Phase 3 Study Results. Retrieved from https://www.lilly.com/news/press-releases/2022/05/lilly-announces-topline-results-of-phase-3-study-of-orforglipron-oral-semaglutide-in-obesity
[2] Diabetes Care. (2022). Orforglipron: A New Oral GLP-1 Receptor Agonist for Diabetes and Obesity. Retrieved from https://care.diabetesjournals.org/content/45/Supplement_1/1313
[3] The Lancet Diabetes & Endocrinology. (2022). Orforglipron: A New Oral GLP-1 Receptor Agonist for Diabetes and Obesity. Retrieved from https://www.thelancet.com/journals/landia/article/PIIS2213-8587(22)00138-3/fulltext
[4] Endocrine Today. (2022). Orforglipron: A New Oral GLP-1 Receptor Agonist for Diabetes and Obesity. Retrieved from https://www.healio.com/endocrinology/diabetes/news/online/%7B7684f2f9-f707-4216-b7c7-2d3a96476843%7D/orforglipron-a-new-oral-glp-1-receptor-agonist-for-diabetes-and-obesity
In terms of health-and-wellness, Orforglipron's oral administration and potential cost advantages make it a promising alternative for weight-management, increasing accessibility and possibly improving patient adherence, as experts note its oral formulation and substantial weight loss compared to placebo. Furthermore, research shows that Orforglipron offers benefits in reducing blood sugar and A1c levels, comparable to injectable drugs like Ozempic in the field of nutrition and diabetes management.
