Eli Lilly, the pharmaceutical company behind GLP-1 injection Zepbound, is working to bring its weight loss drug to the market in pill form.
In an Aug. 7 earnings call, Eli Lilly CEO David Ricks told investors that the company plans to submit the drug, orforglipron, to the FDA for approval by the end of the year. Dan Skovronsky, chief scientific officer and president of Lilly Immunology, said that the company was “very pleased” with the safety and efficacy of orforglipron as seen in trials so far.
Unlike injectable obesity drugs, which are peptides designed to mimic the appetite-controlling GLP-1 hormone, orforglipron is a small molecule pill that is easier to manufacture and package, said Kenneth Custer, president of Lilly’s cardiometabolic health division. Lilly views the once-daily pill as a promising alternative to injections that could be used for early intervention and long-term disease management, Custer said.
Here’s what we know so far about the proposed weight loss pill.
In a clinical trial, the company’s weight loss pill resulted in a nearly 12% weight loss at 72 weeks for participants who took the highest dose of the medication. On average, participants lost 7.8% to 12.4% of their body weight, and 40% of people on the highest dose lost more than 15%, Eli Lilly reported.
The most commonly reported side effects included gastrointestinal issues consistent with other GLP-1s, such as nausea, vomiting, and diarrhea. Five to ten percent of patients discontinued the drug across doses, the company said, which was one of two late-stage trials the drug must pass before being submitted for federal approval.
While Eli Lilly saw the results as indicators of success, investors on the call expressed concerns. Some had hoped that its efficacy would more closely resemble that of existing injections on the market — which can result in up to a 20% body weight loss — while others noted the trial drop-out rate of 12% due to side effects or personal reasons.
While there is not yet an official timeline, Eli Lilly executives have said they plan to submit orforglipron for federal approval by the end of the year. Reviews of New Drug Approval submissions to the FDA usually last one to two years before a drug is greenlit for manufacturing.
Contributing: Alysa Guffey, Indianapolis Star; Reuters
This article originally appeared on USA TODAY: GLP-1 weight loss could soon come in pill form: What to know
