The latest results from a trial of a pill form popular GLP-1 medications offer enough information for the Eli Lilly to request global regulatory approval this year, the company said Tuesday.
Lilly, which makes the injectable drugs Zepbound to treat obesity and Mounjaro and Trulicity to treat diabetes, is among several companies chasing an effective pill form of such GLP-1 receptor agonists. In May, the US Food and Drug Administration accepted Novo Nordisk’s marketing application for an oral version of its weight-loss drug Wegovy, with a decision expected toward the end of the year.
The only semaglutide pill that’s currently available, Rybelsus, treats type 2 diabetes and comes with diet restrictions that are not necessary with Lilly’s pill. To work best, Rybelsus needs to be taken on an empty stomach with no more than 4 ounces of plain water first thing in the morning. The patient should then wait at least 30 minutes to eat, drink or take other medicines.
GLP-1s have been highly popular with millions of people using them for weight loss and diabetes, but injections can have several disadvantages compared with pills. They have to be refrigerated and are more difficult and more expensive to make – and many people just don’t like needles.
The late-stage trial results that Lilly announced Tuesday showed that its GLP-1 pill, orforglipron, was safe and effective at helping people with overweight and obesity and type 2 diabetes. The information was shared in a news release and has not been peer-reviewed or published in a medical journal.
On average, study participants lost an average of 22.9 pounds (10.5% of their weight) on the highest dose of the medication (36 milligrams) after they used orforglipron once a day for 72 weeks.
The pill also lowered A1C – a measurement of the average amount of glucose in the blood over the previous three months – by an average of 1.8%, Lilly said.
Glucose, or blood sugar, is the body’s main source of energy. People who have diabetes can’t make enough insulin, a hormone that helps keep blood sugar levels in a certain range. People with type 2 diabetes may also have cells that are resistant to the effects of insulin.
GLP-1 drugs help control blood sugar by stimulating the pancreas to release insulin and suppressing the release of another hormone to help reduce feelings of hunger and make people feel full for longer.
Lilly has previously released trial results showing that the pill form of its GLP-1 drug was safe and effective for people with overweight and obesity; another announcement focused on results among people who had type 2 diabetes alone. Tuesday’s announcement says the company now has the “full clinical data package required to initiate global regulatory submissions for orforglipron.”
In the latest trial, the pill’s side effects were similar to those reported with injectable forms of GLP-1 drugs. The adverse events were considered generally mild to moderate, according to the company, with upset stomach the most commonly reported.
Dr. Dan Skovronsky, Lilly’s chief scientific officer, said in April that his company has begun mass-producing orforglipron pills after previous promising results.
“That way, we’ll have adequate supply to meet demand,” he said.
Lilly plans to publish the results of its late-stage trial in a peer-reviewed journal. It’s also testing to see whether a pill might help treat high blood pressure and sleep apnea, two conditions that have been helped with certain injectable GLP-1s.
Some experts see a place for the pill version of these drugs as kind of maintenance alternative that people could switch to after reaching a target weight or blood sugar level by using the injectable versions once a week.
