- Eli Lilly said its phase 3 trial of GLP-1 drug in pill form found results similar to popular injectables for weight loss.
- Orforglipron would be used as a daily pill, eliminating the need for temperature control and injections.
- The pill is not yet FDA approved and no information on what it would cost has been released.
Eli Lilly says its GLP-1 drug in pill form is as safe and effective as Ozempic and other mega-popular injectable drugs for weight loss and lowering blood sugar.
The company announced positive results from its phase 3 clinical trial Thursday morning, noting that the drug, orforglipron, has similar results to GLP-1 blockbusters Ozempic and Mounjaro, but doesn’t require the temperature control that’s needed for those injectables. And it’s a daily pill, which would eliminate the need to take a shot to get the benefit.
“In the coming decades, 700 million people around the world will have Type 2 diabetes, and over a billion will have obesity,” Dr. Daniel Skovronsky, Lilly’s chief scientific officer, told the New York Times. “Injections cannot be the solution for billions of people around the world.”
The trial included 559 people who had Type 2 diabetes and were randomized to take either the pill or a placebo for 40 weeks. Those who took the study medication saw a decrease in blood sugar levels similar to that experienced by patients in other studies who took Ozempic or Mounjaro. Lilly said that 65% of those taking the orforglipron had blood sugar that fell into the normal range.
They also lost up to 16 pounds by study’s end. The New York Times reported that was similar to results at 40 weeks with Ozempic, but was slightly less than the weight loss those using Mounjaro experienced in similar unrelated clinical studies.
The side effects were the same, involving gastric issues like diarrhea, indigestion, constipation and nausea.
As CNBC reported, “This more convenient, easier-to-manufacture pill could give Eli Lilly a major edge over Novo Nordisk and other rivals trying to enter the lucrative space."
A “triumph” with more trials underway
Per the Times, “In a way, the very existence of orforglipron is a triumph of modern chemistry. The injectable GLP-1 drugs are peptides — small fragments of proteins. (GLP stands for glucagon-like peptide.) Peptides are digested by the stomach. So, in order to make an oral GLP-1, chemists had to find a way to make a nonpeptide that acts exactly like a peptide. Researchers at Chugai Pharmaceutical Company, a Japanese company, figured out a way, licensing their drug to Lilly in 2018."
Lilly has a number of clinical trials of the pill ongoing, including testing orforglipron in people who don’t have diabetes to see if they, too, lose weight similar to those using the injectable drugs.
A familiar type of drug
KFF, which reports health policy research, polling and news, last May surveyed Americans on use of GLP-1 drugs. The poll found that 12% of adults have taken a GLP-1 agonist drug to lose weight, treat diabetes, or prevent heart attack or stroke because they have heart disease. Among those with diabetes, the share is 43%.
Close to a third of the adults surveyed said they are very aware of the class of drugs.
More than half of those who have used the injectable drugs said they did so for diabetes, while about 4 in 10 said their goal was weight loss.
Nearly all of those who have taken the injectable GLP-1 drugs said the cost was difficult to afford, even if their insurance covered it.
The pill form has not been approved by the U.S. Food and Drug Administration for use outside of approved clinical trials. And it’s not known how the company plans to price and distribute the drug, should it win that approval. So cost could still be a major issue.
Eli Lilly said it would ask the FDA for approval as a Type 2 diabetes treatment in 2026 but will request that regulatory agencies around the world OK the drug for weight management this year.
In the company’s news release, David A. Ricks, Lilly chair and CEO, called the pill form convenient and said that “if approved, could be readily manufactured and launched at scale for use by people around the world.”