An indication with the corporate logo sits outside of the headquarters of Eli Lilly in Indianapolis, Indiana, on March 17, 2024.
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Eli Lilly on Wednesday said its experimental pill outperformed Novo Nordisk‘s own oral drug in the primary head-to-head study comparing the 2 medicines in patients with Type 2 diabetes.
The late-stage study comes as Eli Lilly’s pill inches closer to becoming one other needle-free alternative within the blockbuster marketplace for GLP-1s, without dietary restrictions. Nevertheless it could also be too soon to determine a transparent winner within the pill space, as there isn’t a data comparing Eli Lilly’s drug with a better dose of Novo Nordisk’s pill in patients with obesity.
Eli Lilly said its pill, orforglipron, was superior on the trial’s principal goal of lowering blood sugar levels at 52 weeks compared with Novo Nordisk’s oral semaglutide. The best dose of orforglipron helped lower hemoglobin A1c — a measure of blood sugar levels — by 2.2% compared with 1.4% with Novo Nordisk’s pill.
The best dose of Eli Lilly’s drug also helped patients lose a median of 9.2% of their weight, or 19.7 kilos, compared with 5.3% weight reduction, or 11 kilos, with Novo Nordisk’s pill. Orforglipron’s weight reduction was 8.2% when analyzing all patients no matter discontinuations, while oral semaglutide’s was 5.3%.
The outcomes suggest an as much as 36-milligram dose of Eli Lilly’s pill could also be simpler at treating diabetes patients than an as much as 14-milligram dose of oral semaglutide, which is already approved under the name Rybelsus for Type 2 diabetes.
“For nearly all of patients, this could possibly be the principal medicine that they need to regulate their Type 2 diabetes in addition to their obesity,” Eli Lilly Chief Scientific Officer Dan Skovronsky said in an interview.
Dr. Michael Weintraub, an endocrinologist at NYU Langone Diabetes & Endocrine Associates, said orforglipron’s management of blood sugar levels is “quite impressive not only in comparison with other oral Type 2 diabetes medications but all Type 2 diabetes medications including injectables.”
The corporate on Wednesday said it expects to use for approval of orforglipron for the treatment of Type 2 diabetes in 2026. Eli Lilly hopes to launch its pill globally “this time next 12 months,” CEO David Ricks told CNBC in early August.
Eli Lilly and Novo Nordisk are vying for a greater share of the booming marketplace for GLP-1s, which some analysts say could possibly be price around $100 billion by the 2030s. The space is anticipating more convenient options that would ease the availability shortfalls and access hurdles created by the pricey weekly injections currently dominating it.
Oral GLP-1s could grow to be price $50 billion of that total, in keeping with some analyst estimates.
Limits to the study
Nevertheless it’s less clear how Eli Lilly’s pill compares with higher doses of oral semaglutide, especially in patients who’re obese or have obesity without diabetes. Novo Nordisk expects U.S. regulators to approve a better 25-milligram dose of its pill for the treatment of obesity by the top of the 12 months, and has also studied a 50-milligram dose of the drug in a phase three trial.
Weintraub said comparing the 36-milligram dose of Eli Lilly’s pill to oral semaglutide at a lower dose than what could also be approved in the longer term “is short-changing semaglutide.” He added that patients with diabetes typically lose less weight than those without the condition, so the closer to fifteen% weight reduction that oral semaglutide has shown in individuals with obesity is “definitely not expected” in a study on Type 2 diabetes patients.
Since the trial showed Eli Lilly’s pill was higher at reducing blood sugar and weight only when put next with specific lower doses of oral semaglutide, “there are several orders that form of slow the roll slightly bit as we have a look at the outcomes and get form of excited,” said Dr. Jaime Almandoz, medical director of the Weight Wellness Program at UT Southwestern Medical Center.
Almandoz said it’s “slightly too early to say that one is form of a frontrunner in the category” of medication. But he said head-to-head data is useful as doctors determine which pill could also be a greater fit for certain diabetes patients.
Detailed results on the trial might be presented at a medical meeting and published in a peer-reviewed journal.
The corporate cannot run studies on medicines from competitors that are not approved yet, Skovronsky noted. But he said he’s confident Eli Lilly’s pill can beat higher doses of oral semaglutide in head-to-head trials.
Skovronsky likened orforglipron’s efficacy to that of “new-generation” injectable GLP-1s. He appears to be referring to Eli Lilly’s blockbuster diabetes injection Mounjaro and Novo Nordisk’s competing shot Ozempic.
Meanwhile, Skovronsky said oral semaglutide “is basically acting at a lower level, more much like the first-generation GLP-1s” similar to Victoza and Trulicity, older diabetes injections from Novo Nordisk and Eli Lilly, respectively.
Rybelsus has been in the marketplace for years, meaning that Eli Lilly’s pill might be a late rival within the diabetes space. But each firms are racing to develop oral GLP-1s for obesity.
Unlike Novo Nordisk’s oral semaglutide, Eli Lilly’s pill just isn’t a peptide medication. It’s a small molecule drug that’s absorbed more easily by the body and doesn’t require dietary restrictions.
Trial details
Eli Lilly’s ACHIEVE-3 trial followed nearly 1,700 adults whose Type 2 diabetes was not well managed despite taking an older diabetes drug called Metformin.
Data on orforglipron’s safety, and the way well patients tolerated the drug, was consistent with previous trials. Probably the most common unintended effects were gastrointestinal and mild to moderate in severity.
Eli Lilly said 9.7% of patients on the very best dose of its pill discontinued treatment resulting from unintended effects within the trial. That compares with 4.9% of participants on the very best dose of Novo Nordisk’s drug.
But Eli Lilly noted that the study was not designed to match the security and tolerability of the 2 drugs.
Almandoz said orforglipron’s safety and tolerability were “nothing outside the realm of what one would expect” from GLP-1s.
“I do not think we see any signals there which are concerning with orforglipron relative to semaglutide,” he said.
Skovronsky said the corporate is “satisfied” with the tolerability, adding that it performed consistently with GLP-1 injections.
Meanwhile, Weintraub said seeing a discontinuation rate resulting from unintended effects that’s “almost double” that of Novo Nordsk’s pill “definitely gives me pause.” He said Eli Lilly’s pill has shown an analogous rate in previous late-stage trials, so its gastrointestinal unintended effects are “likely something we’ll have to be mindful of and counsel patients accordingly.”
