2023-06-24 12:41:03
Dubai, United Arab Emirates (CNN) — Eli Lilly’s experimental weight loss pill helped people lose 15% of their body weight after 36 weeks on the highest dose taken during a mid-stage trial, which rivals what was seen with approved therapies. Currently injectables such as Wegovy are taken over longer periods.
In a study published in the New England Journal of Medicine Friday, researchers reported that the drug orforglipron has side effects similar to those in this class, known as GLP-1 receptor agonists, that include primary gastrointestinal events such as nausea, constipation and vomiting. The results of the Lilly-funded trial were presented at the American Diabetes Association conference in San Diego.
Currently approved weight loss medications such as Novo Nordisk’s Wegovy are given as injections once a week. Ozempic from Novo Nordisk which contains the same main ingredient as Wegovy, called semaglutide, and Lilly’s Moonjaro are approved for type 2 diabetes, but they are also used for weight loss without mentioning it in the labeling. Orforglipron is part of a new group of experimental drugs that pursue the same target, GLP-1, but by taking a daily pill.
“Choice for patients is really important,” said Dr. Nadia Ahmed, associate vice president of Lilly, which oversees the development of medications for chronic weight management.
She noted that weight loss thanks to orforglibrone did not appear to stabilize at the 36-week limit in the trial, and said that later-stage studies are under way to test the drug for a longer period of time to assess its full efficacy.
The 15% weight loss observed with the four highest doses tested in the study is significant, she said, because that range is where it really starts to affect some of the other complications that these obese patients have.
The drug was tested on 272 people with an average starting weight of 108.7 kilograms, or about 240 pounds. The trial enrolled patients who were obese, measured with a BMI of 30 or greater, or overweight, with a BMI of at least 27, and a weight-related health condition. They tested four doses ranging from 12 to 45 milligrams, compared to a placebo. Participants also received diet and exercise counseling.
The results showed that weight loss over 36 weeks ranged between 9.4% and 14.7%, compared to 2.3% for those taking a placebo. Participants reported positive effects of the drug on triglyceride and cholesterol levels, as well as systolic blood pressure, or the pressure measurement when the heart beats. There was no significant change in diastolic blood pressure, which is the pressure measured when the heart is resting between beats.
The study showed that side effects including nausea, constipation, vomiting and diarrhea were the most common. The study found that although most cases were of “mild to moderate” severity and occurred when participants gradually increased their dose of the drug, between 10% and 17% stopped taking the drug because of it.
The researchers, led by Dr. Sean Wharton of the Wharton Clinic, note in the NEJM paper that the study is designed to help determine the best dose, and the best way to increase the dose over time during larger, later-stage studies.
One limitation, the researchers note, is that 91% of the participants in the experiment were white. Ahmed said the goal for Lilly and the pharmaceutical industry more broadly is to achieve better diversity in clinical trials, and she noted that Phase 3 studies of Lilly’s drug would have a better representation of more groups.
And Nighttime is just one of a group of experimental weight-loss drugs seeking to join blockbuster drugs like Wegovy on the market. And Novo Nordisk announced that results last month showed that a version of its semaglutide pill resulted in 15% weight loss over 68 weeks, matching Wegovy’s results.
But the drug, which has been approved as Rybelsus for type 2 diabetes, is complicated to take, doctors say, because it comes with strict requirements, such as not eating or drinking within 30 minutes of taking it.
Drugs still need to complete large-scale testing in Phase III trials, which means they may take months to years to get to market.
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