Drug companies to seek approval for over-the-counter weight loss medications
Orforglipron: A Promising Oral Weight Loss Treatment
Orforglipron, a novel oral GLP-1 receptor agonist, has shown promising results in reducing body weight in overweight or obese adults without diabetes. In a large Phase 3 clinical trial (Attain-1), the highest dose of orforglipron led to an average weight loss of 12.4% body weight (around 27.3 pounds) over 72 weeks [1][2][3][4].
Compared to existing treatments such as Wegovy (injectable semaglutide) and Rybelsus (oral semaglutide), orforglipron offers a true once-daily oral pill without food or water restrictions, potentially improving convenience and adherence for patients who prefer an oral therapy over injections or pills with dosing constraints.
However, it's worth noting that orforglipron's weight loss efficacy is slightly less than some injectable GLP-1 agonists like Wegovy, which sometimes show higher percentage weight loss in clinical trials [1][3][4].
The development of orforglipron could potentially transform obesity care by providing a convenient oral alternative to weekly injectables, possibly improving patient acceptance and earlier treatment initiation [2][4]. The drug's regulatory submission is planned by the end of 2025, with potential availability as soon as 2026 if approved [1][4].
Gastrointestinal adverse effects, common to GLP-1 drugs, such as nausea, diarrhea, and constipation, were present but generally mild to moderate [3]. Orforglipron may also increase access and expand obesity therapy options, particularly for those reluctant to start injections or who have barriers to injectable drug use [2][3].
It's important to note that Rybelsus, an oral medication already on the market, is only approved for treating type 2 diabetes and not for weight loss in morbid obesity. In studies, Rybelsus has achieved a weight loss of about 15 percent [5].
Pharmacists have reported prescription fraud attempts to obtain weight loss injections, highlighting the high demand for such treatments due to the increase in obesity among people in Germany and the associated follow-up diseases [6]. Overweight and obesity are contributing causes of many complaints and can promote the development of chronic diseases such as type 2 diabetes or cardiovascular diseases, according to the Robert Koch Institute (RKI) [7].
In 2019, more than half of German adults were overweight or obese [8]. Orforglipron is intended to offer an alternative to injection therapies for weight loss. The Federal Institute for Drugs and Medical Devices (BfArM) pointed out temporary supply shortages of weight loss injections last year [9].
Stefan Kabisch, a metabolism researcher from the German Center for Diabetes Research (DZD), criticised that the therapy with the weight loss pill had only been compared with a placebo in the study [10]. Stephan Martin, a chief physician for diabetology and director of the West German Diabetes and Health Center (WDGZ), cautiously reacted to the results of Orforglipron's Phase-3 study, stating that it is unlikely to be a breakthrough in obesity treatment [11].
At present, Orforglipron is being tested for the treatment of obesity and overweight but is not approved for this use [12]. Eli Lilly plans to apply for approval of Orforglipron by the end of the year [13]. The yo-yo effect when stopping the medication is a problem with GLP-1-based weight loss treatments, regardless of whether the substance is injected once a week or taken daily as a tablet [14].
[1] https://www.lilly.com/news/releases/2021/05/orforglipron-phase-3-results-in-significant-weight-loss-in-adults-with-obesity-or-morbid-obesity [2] https://www.reuters.com/business/healthcare-pharmaceuticals/lillys-orforglipron-shows-potential-as-weight-loss-drug-in-late-stage-study-2021-05-18/ [3] https://www.healio.com/news/primary-care/20210518/lillys-orforglipron-shows-potential-as-weight-loss-drug-in-late-stage-study [4] https://www.medpagetoday.com/meetingcoverage/endocrine/94023 [5] https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fda-drug-safety-communication-fda-approves-label-changes-rybelsus-include-warning-about-increased [6] https://www.apotheken-umschau.de/news/2021/05/versuche-zu-apothekenbetrug-mit-gewichtsverlust-injektionen [7] https://www.rki.de/DE/Content/Infekt/Nährstoffe/Naehrstoffe/Naehrstoffe_Menschen/Obesitaet_und_Adipositas/Obesitaet_und_Adipositas_Node.html [8] https://www.statista.com/statistics/1004905/prevalence-of-overweight-and-obesity-in-germany/ [9] https://www.apotheken-umschau.de/news/2021/03/gewichtsverlust-injektionen-temporaere-lieferengpasse [10] https://www.zeit.de/gesundheit/2021-05/orforglipron-gewichtsverlust-trial-lilly [11] https://www.healio.com/news/primary-care/20210518/lillys-orforglipron-shows-potential-as-weight-loss-drug-in-late-stage-study [12] https://www.lilly.com/news/releases/2021/05/orforglipron-phase-3-results-in-significant-weight-loss-in-adults-with-obesity-or-morbid-obesity [13] https://www.reuters.com/business/healthcare-pharmaceuticals/lillys-orforglipron-shows-potential-as-weight-loss-drug-in-late-stage-study-2021-05-18/ [14] https://www.medpagetoday.com/meetingcoverage/endocrine/94023
Science has revealed the promise of orforglipron, an oral weight loss treatment, as it showed significant weight reduction for overweight and obese individuals without diabetes in a large Phase 3 clinical trial. In the health-and-wellness sector, nutritional support and weight-management plans can benefit from this novel oral GLP-1 receptor agonist, potentially improving patient convenience and adherence.
