A sign with the company logo sits outside of the headquarters of Eli Lilly in Indianapolis, Indiana, on March 17, 2024.
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Eli 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 the way for its entrance into the market.
The pill’s weight loss was 11.2% when analyzing all patients regardless of discontinuations.
Shares of the company fell more than 7% in premarket trading on Thursday.
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 said the results appear to be comparable to, but overall slightly lower, the level of weight loss seen with Novo Nordisk‘s blockbuster weekly GLP-1 injection for obesity, Wegovy.
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 promising result for an oral agent,” said Dr. Jaime Almandoz, medical director of the Weight Wellness Program 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.
Dr. Mihail “Misha” Zilbermint, director of Endocrine Hospitalists at 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 follow positive data in April from a phase 3 trial examining the experimental pill in diabetes patients. They bring Eli Lilly’s pill, orforglipron, one step closer to becoming the first new, needle-free alternative without dietary restrictions in the booming market for weight loss and diabetes drugs called GLP-1s.
Eli Lilly is “not disappointed with these results. It’s right on thesis for us,” despite being “one or two points below what the Street had,” CEO David Ricks told CNBC’s “Squawk Box.”
“The goal was to create an oral pill that was convenient and can be made at a huge scale, really, for the mass market, and had weight loss that was competitive with other single-acting GLP-1s, and that’s what we’ve achieved,” Ricks said. He added that the pill’s percentage of weight loss is “in the range” of what most people who are overweight or want to improve their metabolic health want to achieve.
Ricks said Eli Lilly expects to submit the data to regulators by the end of the year, with hopes of launching the pill around the world “this time next year.”
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-manufacture 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.
There are roughly 8 million patients on injectable obesity and diabetes drugs, but likely around 170 million who could benefit from the medicines, said Ken Custer, president of Lilly Cardiometabolic Health, in an interview.
“In order to meet that demand, we’re going to need other options, including oral small molecules like orforglipron, which use different means of production and also don’t need as sophisticated of a supply chain to distribute it to patients,” he said.
Dr. Amy Sheer, professor of medicine and program 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. Wegovy and other drugs have list prices of roughly $1,000 before insurance.
Detailed trial results
The 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 proportion of people who achieved “greater magnitudes” of weight loss was “very impressive for an oral agent,” adding that many people “often…
Read More: Eli Lilly obesity pill orforglipron led to 12% weight loss