Eli Lilly's obesity pill led to around 12% weight loss in closely watched late-stage trial, paving way for approval

A sign with the company logo sits outside of the headquarters of Eli Lilly in Indianapolis, Indiana, on March 17, 2024.Scott Olson | Getty ImagesEli Lilly on Thursday said the highest dose of its daily obesity pill helped patients lose almost 12% of their body weight, or roughly 27 pounds, at 72 weeks in a late-stage trial, paving way for its entrance into the market.s of the company fell more than 12% in premarket trading on Thursday

Some doctors said the results appear to be comparable to, if not slightly lower, the level of weight loss seen with Novo Nordisk's blockbuster weekly GLP-1 injection for obesity, Wegovy.The data comes under what some Wall Street analysts were expecting for Eli Lilly's oral GLP-1, with hopes for weight loss of around 15%

Some doctors also made note of the number of patients on the highest dose of the pill who discontinued treatment due to side effects or any other reason in the trial.Still, other doctors lauded the results and the potential of the pill to reach new patients, such as those who are afraid of needles. "This is a strong and mising result for an oral agent," said Dr

Jaime Almandoz, medical director of the Weight Wellness gram at UT Southwestern Medical Center, calling the weight loss "a significant and clinically meaningful outcome.""Injectables have set a high bar, but this study reinforces the potential for an oral GLP-1 to be transformative in obesity care, particularly for patients who are hesitant to start or maintain injectable therapies," he continued

Mihail "Misha" Zilbermint, director of Endocrine Hospitalists at the Johns Hopkins Community Physicians, said he believes the pill "has the potential to be a game changer, as long as people can tolerate the side effects."The trial results are among the pharmaceutical industry's most closely watched studies of the year, and positive data in April from a phase three trial examining the experimental pill in diabetes patients

They bring Eli Lilly's pill, orforglin, one step closer to becoming the first new, needle-free alternative in the booming market for weight loss and diabetes drugs called GLP-1s

Eli Lilly expects to submit the data to regulators by the end of the year, with plans to launch the pill in 2026, Ken Custer, president of Lilly Cardiometabolic Health, said in an interview

That launch could fundamentally shift the space, helping more patients access the treatments and alleviating the supply shortfalls of existing injections

The more convenient and easier-to-manufacturer pill could also help Eli Lilly solidify its dominance in the growing segment as other drugmakers, including its main rival Novo Nordisk, race to bring weight loss pills to market

Custer said there are roughly 8 million patients on injectable obesity and diabetes drugs, but ly around 170 million who could benefit from the medicines. "In order to meet that demand, we're going to need other options, including oral small molecules orforglin, which use different means of duction and also don't need as sophisticated of a supply chain to distribute it to patients," he said.Dr

Amy Sheer, fessor of medicine and gram director of the Obesity Medicine Fellowship at University of Florida, said she hopes the pill will be less expensive than existing injections, which are costly largely due to the devices they come in

She said lower prices could help eliminate barriers to access for patients, potentially making insurers more willing to cover the drug

Many insurers still don't cover GLP-1s for obesity

Detailed trial resultsThe highest dose of Eli Lilly's pill helped more than 59% of patients lose at least 10% of their body weight and more than 39% of patients lose at least 15% of their weight, according to the trial results

Almandoz said the portion of people who achieved "greater magnitudes" of weight loss was "very impressive for an oral agent," adding that many people "often overlook the portion of people achieving these high weight loss " and typically focus closely on the average weight lossOrforglin also helped lessen cardiovascular risk factors.But data on how well some patients tolerated the pill in the trial came under some analysts' estimates. 10.3% of patients who took the highest dose of the pill — 36 milligrams — discontinued treatment due to side effects, compared with around 2.6% of those who took placebo

Those side effects were mainly gastrointestinal, such as nausea and vomiting, and mild to moderate in severity

An estimated 24% of those who took the highest dose experienced vomiting, while 33.7% and 23.1% had nausea and diarrhea, respectively.Ahead of the data, BMO Capital analyst Evan Seigerman said he expected less than 10% of patients on the highest dose of the pill to discontinue treatment due to side effects and lower rates of vomiting, nausea and diarrhea.More patients stopped taking the pill due to side effects compared with existing GLP-1s on the market, said Dr

Caroline Apovian, co-director of the Center for Weight Management and Wellness at Brigham and Women's Hospital

The discontinuation rates due to side effects in late-stage trials on Wegovy and Eli Lilly's weekly obesity injection Zepbound are around 7% or less.She noted that almost a quarter of patients on the highest dose of the pill discontinued treatment for any reason, cautioning that the enthusiasm for orforglin should be tempered "because we get all this excitement, and then the pill comes out, and then nobody can take it."It's un why, apart from side effects, those patients discontinued the pill.But University of Florida's Sheer said she doesn't believe the discontinuation rates or side effects will be a deciding factor for physicians when prescribing the pill

She believes an oral option could actually make more physicians more comfortable prescribing a GLP-1 to patients

Some physicians are currently hesitant to prescribe injections because they "may not know how to tell patients how to use them," Sheer added

Almandoz said prescribing decisions are going to depend on the patient's specific needs and preferences, as well as access and affordability

An injectable GLP-1 may be the preferred option for patients whose priority is a greater level of weight loss or those who have significant cardiometabolic complications, or health issues that arise from cardiovascular diseases and metabolic disorders

But an oral GLP-1 could be the best fit for those who "prioritize simplicity or convenience or have these logistical challenges with injections," he said.The detailed results from the trial will be presented in September at a European medical meeting and published in a peer-reviewed journal

More phase three trial results on the pill will be d later this year, including from a study on adults who have obesity or are overweight and have Type 2 diabetes.Wegovy, Eli Lilly's pill, orforglin and Novo Nordisk's diabetes pill Rybelsus all work by targeting a gut hormone called GLP-1 to mote weight loss and regulate blood sugar

But un those other medications, Eli Lilly's pill is not a peptide medication

Oral GLP-1s could grow to be worth $50 billion of that total, Fernandez said.-- CNBC's Angelica Peebles contributed to this report.