An experimental GLP-1 pill helped people with obesity lose a significant amount of weight in a late-stage clinical trial, which suggests people who fear needles might soon have a way to take these medicines without the need for injections.
For the trial, scientists randomly assigned more than 3,000 adults who were overweight or had obesity to take one of three different doses of the experimental pill, orforglipron, or a placebo pill, for 72 weeks. All the participants had at least one weight-related medical problem, but none of them had diabetes.
Weight Loss Pill Could Be a New Choice for People With Obesity
The pill appears to be as safe and well-tolerated as injected GLP-1 drugs, Lilly said. The most common side effects were mild to moderate gastrointestinal issues, with about one-third of patients on the highest orforglipron dose experiencing nausea and about one-quarter experiencing constipation or diarrhea.
About 10 percent of people on the highest orforglipron dose stopped the study because of side effects, compared with 2.6 percent of people on the placebo pill.
The pill can be taken without any restrictions on the timing of food or water, according to Lilly.
The ability to avoid needles, and to eat and drink without restrictions, should make this new GLP-1 pill an appealing option to some patients who can’t take the injected GLP-1 drugs, says Marilyn Tan, MD, a clinical associate professor and endocrinologist at the Stanford University School of Medicine in California.
“For those who don’t want injections and who need less-substantial weight loss, the oral pill is a good option,” Dr. Tan says.
GLP-1 Pill Doesn’t Lead to as Much Weight Loss as Injectable Drugs
Tan says the weight loss seen so far with orforglipron isn’t as dramatic as that achieved with injected GLP-1 drugs. People who take the maximum dose of an injected GLP-1 drug can lose around 20 percent of their body weight, Tan notes — much more than what this trial found for the maximum dose of the GLP-1 pill.
The trial results released by Lilly haven’t been published in a medical journal or reviewed by independent experts to ensure the accuracy of the findings.
When Will Orforglipron Be Available?
Lilly said it plans to seek approval from the U.S. Food and Drug Administration (FDA) for orforglipron by the end of the year.
Once the pill wins FDA approval, it may still be hard for some people to get it because insurance often doesn’t pay for weight loss drugs, Tan says. “Even though they are FDA approved, cost remains prohibitive for many patients.”
If the pill costs a lot less out-of-pocket than injected GLP-1 drugs, this may lead more people to choose it even though it may not produce as much weight loss, says Clifford Rosen, MD, a professor at Tufts University School of Medicine and the associate director of the MaineHealth Institute for Research in Scarborough.
“The relative differences in weight loss will not be a deterrent, especially if the cost is less,” Dr. Rosen says. “It should be a great alternative.”