The Eli Lilly headquarters in Indianapolis, Indiana, on Aug. 15, 2024.
AJ Mast | Bloomberg | Getty Images
A version of this article first appeared in CNBC’s Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.
Eli Lilly‘s closely watched obesity pill is inching closer to entering the market.
The drug, orforglipron, succeeded in another late-stage trial, helping patients with both obesity and Type 2 diabetes lose weight and lower their blood sugar levels. Eli Lilly now has all the data it needs to start filing for approvals of the daily pill for chronic weight management by the end of the year.
It could become a new needle-free alternative in the blockbuster GLP-1 market, helping to ease the supply shortfalls and access hurdles of existing injections. Eli Lilly’s pill is easier to manufacture than a shot and does not require dietary restrictions, and some health experts hope it could cost less than injections.
Eli Lilly’s Chief Scientific Officer Daniel Skovronsky broke down the trial results with CNBC.
On the biggest take-home message of the data:
Skovronsky said orforglipron passed the so-called ATTAIN-2 trial “with flying colors.” The study is the second of two large phase three trials for the treatment of obesity. He said the pill met the main and secondary goals of the study, and its safety and tolerability data were “just as we expected, consistent with the [GLP-1] class.”
Skovronsky said it’s difficult to compare the trial to separate studies on other GLP-1s. But overall, he called the data “in line with the injectables” in patients with obesity and Type 2 diabetes, a notoriously “hard-to-treat” population that has a difficult time losing weight.
“To get this kind of unprecedented efficacy in this population, and to get it with an oral, it’s just really satisfying and exciting,” Skovronsky said.
The highest dose of the pill helped patients lose 10.5% of their weight, or 22.9 pounds, on average, at 72 weeks. The drug’s weight loss in the study was 9.6% when analyzing all patients regardless of discontinuations.
Skovronsky said more than half of the patients on the drug lost at least 10% of their body weight in the trial, which he called a “life-changing level of weight loss.”
Orforglipron also lowered hemoglobin A1C – a measure of blood sugar levels – by an average of 1.3% to 1.8% across different doses at 72 weeks, from a starting level of 8.1%. By the end of the study, most patients no longer met the criteria for Type 2 diabetes based on that metric.
“I just think it’s exciting – a huge relief now to have the full data package that confirms the safety and confirms efficacy” of orforglipron, Skovronsky said.
Shares of Eli Lilly climbed more than 4% Tuesday afternoon following the results. The move comes after investors battered the company’s stock in early August, when the pill fell short of Wall Street’s expectations in a separate trial on patients with obesity.
“I think after the prior data readout, people could have asked questions” about orforglipron, Skovronsky said. “This readout puts those questions to rest.”
On the pill’s side effects and discontinuation rates:
Some health experts have raised concerns about the rates of side effects and patients who stopped treatment in the trial.
Eli Lilly said 10.6% of patients on the highest dose stopped taking the pill due to side effects, which were mainly gastrointestinal-related and mild to moderate in severity.
Some experts have pointed out that the discontinuation rates due to side effects in late-stage trials on obesity injections from Novo Nordisk and Eli Lilly are around 7% or less.
An estimated 23.1% of those who took the highest dose of Eli Lilly’s pill experienced vomiting, while 36.4% and 27.4% had nausea and diarrhea, respectively. But Skovronsky said side effects typically “go away as [people] stay on the medicine.”
Around 20% of patients stopped treatment for any reason, which is roughly the same as the placebo group.
But Skovronsky said, “it’s not that they don’t want to be on this medicine.”
He said the discontinuations are due to multiple factors apart from side effects. Those can include patients who wanted to stop participating in a trial because they were able to access another obesity medication or those who didn’t lose enough weight because they were taking a lower dose of the drug. He said that is “no longer an issue” when you take a higher dose.
“Maybe they got a new job and their insurance covers [an existing obesity drug] now and they say, ‘Why should I take the chances on something unproven when I could just be on the injections?'” Skovronsky said, adding that many patients “didn’t have any kind of alternative” for treatment when the trial started.
In other cases, people move, change care or “something else happens in their life and they no longer want to be in a clinical trial,” he added.
Overall, Skovronsky said most patients stay on the drug, and that “the most important thing here is the scale of the opportunity” of people around the world who could benefit from it. More than 100 million adults in the U.S. alone have obesity, according to Centers for Disease Control and Prevention data.
On his hopes for the pill’s future:
“I think this is going to be an important option,” Skovronsky said. “Maybe it will become seen as the most powerful oral medication for treatment of Type 2 diabetes, and certainly Type 2 diabetes with obesity, as we saw in this trial.”
He said he hopes that an oral option without food and water restrictions could allow people to start using it earlier in the course of their disease to slow its progression.
“I think that’s one of the important uses here, the early intervention,” he said.
Unlike other GLP-1s, Eli Lilly’s pill is not a peptide medication. It is a small-molecule drug that is absorbed more easily by the body and does not require dietary restrictions like Novo Nordisk’s diabetes pill Rybelsus and the oral version of Wegovy, which could enter the market at the end of the year.
Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.
Latest in health-care: Stephen Hemsley’s first 100 days
UnitedHealthcare signage is displayed on an office building in Phoenix, Arizona, on July 19, 2023.
Patrick T. Fallon | Afp | Getty Images
If you’ve lived through a big renovation, one thing you learn is that rehab projects always cost more and take longer than you think they will.
Stephen Hemsley helped build UnitedHealth Group into the giant it is today through strategic acquisitions during his first stint as CEO. Now, three months into his return to the job, he’s moving quickly on an ambitious and strategic turnaround.
While pushing to bring the company’s Medicare program and Optum Health physician unit back to profitability, Hemsley has also prioritized the rehabilitation of UnitedHealth’s reputation.
The murder in December of the company’s insurance chief Brian Thompson, by an accused gunman who appeared to have a history of claims denials, ignited an outpouring of public criticism in the months following the killing. At the same time, published reports of a federal criminal probe into the company’s Medicare program stoked investor concern and weighed on the stock.
“We have embarked on a real cultural shift in our relationship with regulators and all external stakeholders … and intend to be proactively engaged, constructive and responsive,” Hemsley said on the company’s second-quarter earnings call.
In his first 100 days, he’s made three moves to take control of the narrative. In June, he announced outside auditors would look at UnitedHealth’s billing and business practices. In July, the company initiated a meeting with the Department of Justice and confirmed that its Medicare program is under investigation. Then last week, UnitedHealth announced a new Public Responsibility Committee, as part of its board of directors, which will focus on regulatory and stakeholder concerns.
As with any big renovation project, it’s going to take time to rebuild the business fundamentals. Rehabbing the company’s public reputation could be the part that takes even more time and diligence.
Feel free to send any tips, suggestions, story ideas and data to Bertha at bertha.coombs@nbcuni.com.
