A sign with the company logo is outside the headquarters of Eli Lilly in Indianapolis, Indiana, on March 17, 2024.
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Eli Lilly On Wednesday he said that his experimental pill surpassed Novo NordiskThe oral drug itself in the first study of the head to face that compares the two medications in patients with type 2 diabetes.
The study of the late stage occurs when the Eli Lilly pill is close to becoming another needle without needle in the market of great success for LPG-1, without dietary restrictions. But it can be too early to establish a clear winner in the space of the pill, since there are no data that compare Eli Lillly's medication with a higher dose of the Novo Nordisk pill in patients with obesity.
Eli Lilly said his pill, orforglipron, was superior in the main objective of reducing blood sugar levels at 52 weeks compared to the oral semagglutida of Novo Nordisk. The highest dose of Orforglipron helped reduce A1C hemoglobin, a measure of blood sugar levels, in 2.2% compared to 1.4% with the Novo Nordisk pill.
The highest dose of Eli Lilly's drug also helped patients lose an average of 9.2% of their weight, or 19.7 pounds, compared to the weight loss of 5.3%, or 11 pounds, with the Novo Nordisk pill. The weight loss of orforgripron was 8.2% when analyzing all patients, regardless of discontinuations, while oral semaglutida was 5.3%.
The results suggest that a dose of up to 36 milligrams of the Eli Lilly pill can be more effective to treat patients with diabetes than a dose of up to 14 milligrams of oral semaglutida, which is already approved under the name of Rybelsus for type 2 diabetes.
“For most patients, this could be the main medication they need to control their type 2 diabetes, as well as their obesity,” said Eli Lilly scientific director Dan Skovronsky, in an interview.
Dr. Michael Weintraub, endocrinologist of Nyu Langone Diabetes & Endocrine Associates, said the management of orforgripron of the blood sugar levels “quite impressive not only compared to other oral diabetes medications, but of all medications for type 2 diabetes, including injectables.”
The company said Wednesday that he hopes to request the approval of Orforglipron for the treatment of type 2 diabetes in 2026. Eli Lilly hopes to launch its worldwide pill “this time this time next year,” said CEO David Ricks to CNBC in early August.
Eli Lilly and Novo Nordisk compete for a higher booming market proportion for LPG-1, which some analysts say that around $ 100 billion could be worth for the 2030s. The space is anxious for more convenient options that can relieve supply deficit and access obstacles created by the expensive weekly injections that currently dominate it.
Oral LPG-1 could grow to be worth $ 50 billion of that total, according to some estimates of analysts.
Limits for study
But it is less clear how Eli Lilly's pill is compared with higher doses of oral semaglutida, especially in overweight patients or who have obesity without diabetes. Novo Nordisk expects US regulators to approve a higher dose of 25 milligrams of their pill for the treatment of obesity by the end of the year, and has also studied a dose of 50 milligrams of the drug in a phase three test.
Weintraub said that comparing the dose of 36 milligrams of Eli Lilly's pill with the oral semaglutida with a lower dose than can be approved in the future “is the semagglutide that changes in the short term.” He added that patients with diabetes generally lose less weight than those without condition, so the weight loss closest to 15% than oral semaglutida has demonstrated in people with obesity “is certainly expected” in a study on patients with type 2 diabetes.
Because the trial showed that Eli Lilly's pill was better to reduce the sugar and the weight of the blood only compared to the lowest doses of oral semaglutid Southwestern.
Almandoz said it is “too soon to say that one is a kind of leader in the” drugs. But he said that direct data is useful since doctors determine which pill can be better for certain diabetes patients.
The results detailed in the trial will be presented at a medical meeting and will be published in a peer reviewed magazine.
The company cannot direct studies on competitors medications that are not yet approved, Skovronsky said. But he said he is confident that Eli Lilly's pill can beat the highest doses of oral semaglutida in face -to -face tests.
Skovronsky compared the effectiveness of orforgripron with that of the “new generation” GLP-1. It seems that it is referring to the successful injection of diabetes of Eli Lilly, Mounjaro and the competition of Novo Nordisk, Ozempic.
Meanwhile, Skovronsky said that the oral semaglutida “is really working at a lower level, more similar to the first-generation LPG-1 such as Victaza and Trulicity, the oldest diabetes injections of Novo Nordisk and Eli Lilly, respectively.
Rybelsus has been on the market for years, which means that Eli Lilly's pill will be a late rival in the diabetes space. But both companies are running to develop oral LPG-1 for obesity.
Unlike Novo Nordisk's oral semaglutid, Eli Lilly's pill is not a peptide medication. It is a small molecule medication that the body absorbs more easily and does not require dietary restrictions.
Test details
Eli Lilly's Acche-3 trial followed almost 1,700 adults whose type 2 diabetes was not well managed despite taking a major diabetes medication called Metformin.
Orforglipron security data, and how well, patients tolerated the medication were consistent with previous trials. The most common side effects were gastrointestinal and mild to moderate in gravity.
Eli Lilly said that 9.7% of patients in the highest dose of their pill suspended treatment due to side effects on the test. That compares with 4.9% of participants in the highest dose of Novo Nordisk's drug.
But Eli Lilly said the study was not designed to compare the safety and tolerability of the two drugs.
Almandoz said that the safety and tolerability of orforgripron was not “nothing outside the kingdom of what one would expect” of the LPG-1.
“I don't think we see any signal there that is worrying with Orforglipron in relation to Semaglutide,” he said.
Skovronsky said the company is “satisfied” with tolerability, adding that it worked consistently with LPG-1 injections.
Meanwhile, Weintraub said that seeing an interruption rate due to side effects that is “almost double” that Novo Nordsk's pill “certainly pauses me.” He said that Eli Lilly's pill has demonstrated a similar rate in the previous tests of the late stage, so its gastrointestinal side effects are “probably something that we will have to be aware and advise patients accordingly.”
