An experimental drug has helped people who are obese or overweight lose about 22.5% of their body weight, or about 52 pounds on average, in a large trial, the drug’s maker announced Thursday.
The company, Eli Lilly, has not yet submitted the data for publication in a peer-reviewed medical journal or presented it in a public setting. But the claims have nonetheless stunned medical experts.
“Wow (and a double wow!),” wrote Dr. Sekar Kathiresan, chief executive of Verve Therapeutics, a heart disease drug company. in a tweet. Drugs like Eli Lilly’s, he added, “will truly revolutionize the treatment of obesity!!!”
Dr. Kathiresan has no connection with Eli Lilly or drugs.
Dr. Lee Kaplan, an obesity expert at Massachusetts General Hospital, said the drug’s effect “appears to be significantly better than any other anti-obesity drug currently available in the United States.” The results, he added, are “very impressive”. .”
Dr Kaplan, who consults for a dozen pharmaceutical companies including Eli Lilly, said he was not involved in the new trial or the development of this drug.
On average, study participants weighed 231 pounds at baseline and had a body mass index, or BMI — a commonly used measure of obesity — of 38. (Obesity is defined as a BMI of 30 and over .)
At the end of the study, those taking the highest doses of the Eli Lilly drug, called tirzepatide, weighed about 180 pounds and had a BMI just below 30, on average. The results far exceed those usually seen in weight loss drug trials and are usually seen only in surgical patients.
Some trial participants lost enough weight to fall into the normal range, said Dr. Louis J. Aronne, director of the comprehensive weight control program at Weill Cornell Medical Center, who worked with Eli Lilly as a principal investigator of the study.
Most people in the trial were ineligible for bariatric surgery, which is reserved for people with a BMI over 40, or those with a BMI of 35 to 40 with sleep apnea or diabetes. type 2. The risk of developing diabetes is several times higher for obese people than for others.
A spokeswoman for Eli Lilly said the company does not have a public timeline for seeking the drug’s approval from the Food and Drug Administration.
Because obesity is a chronic disease, patients should take tirzepatide for life, just as they do blood pressure or cholesterol medications, for example.
Dr. Robert F. Kushner, an obesity expert at Northwestern University’s Feinberg School of Medicine and a Novo Nordisk paid consultant, said the new drug, along with a similar but less effective drug from Novo Nordisk, can fill a gap. -so-called treatment gap.
Diet and exercise, combined with prior obesity medications, typically result in about 10% weight loss in patients. That’s enough to improve health, but not enough to make a big difference in the lives of obese people.
The only other treatment is bariatric surgery, which can result in substantial weight loss. But many people aren’t eligible or just don’t want to have the surgery.
With Eli Lilly’s drug and Novo Nordisk’s recently approved semaglutide, “we are truly at the dawn of a new method of treatment,” Dr. Kushner said.
But prices can be an obstacle. Often, insurers do not pay for weight-loss drugs. The drug Novo Nordisk, whose brand name is Wegovy, has a list price of $1,349.02 per month.
Experts fear that tirzepatide, if approved, could be priced in the same range. Many people who could benefit the most from weight loss may not be able to afford such expensive drugs.
The Eli Lilly study lasted 72 weeks and involved 2,539 participants. Many were considered obese, while others were overweight but also had risk factors such as high blood pressure, high cholesterol, cardiovascular disease or obstructive sleep apnea.
They were divided into four groups. All received dietary advice to reduce their caloric intake by approximately 500 per day.
One group was randomly assigned to take a placebo, while the other three received doses of tirzepatide ranging from 5 milligrams to 15 milligrams. Patients injected the drug once a week.
Those who took the highest dose lost the most weight, the investigators found. Participants taking a placebo lost 2.4% of their weight, or an average of 5 pounds, typical of a diet study.
Dr Nadia Ahmad, senior medical director of Eli Lilly’s obesity program, said seeing the results was an emotional moment for her.
“I don’t think I ever imagined that we could achieve this degree of weight loss with medication,” she said. “We only reached this stage with surgery.”
For decades, people who were overweight or obese were told that it was up to them to fix the problem. Diet and exercise were the prescriptions, and they just didn’t work for a lot of people. Most have tried diet after diet, only to regain the lost weight.
Last year, that began to change when Novo Nordisk received Food and Drug Administration approval to market semaglutide. The drug can cause 15-17% weight loss in obese people.
The drugs are part of a new class of drugs called incretins, which are naturally occurring hormones that slow stomach emptying, regulate insulin and decrease appetite. Side effects include nausea, vomiting, and diarrhea. But most patients tolerate or are not bothered by these effects.
Incretins raise the bar for the type of weight loss possible with drugs. But they also ask tough questions about whether bariatric surgery is becoming a relic of the past. There are already new versions of incretins in development that may be even more potent than the drug Eli Lilly.
Even without them, Dr. Aronne said, the reductions seen with the drug Eli Lilly are “downright on the order of surgical weight loss.”
Some patients who have undergone bariatric surgery describe mixed results. Obesity Action Coalition board member Sarah Bramblette underwent bariatric surgery just to gain weight back.
Now 44, she weighed 500 pounds when she had surgery 20 years ago, which saw her down to 250 pounds. Over the years, however, his weight has rebounded to 490 pounds. She needed heart surgery, but she was too heavy for the operating table. Diets – and she tried them many times – didn’t help.
Novo Nordisk’s semaglutide got him down to 430 pounds. Now, Ms Bramblette said, she would like to try the drug Eli Lilly if it becomes available.
“Believe me, I wouldn’t choose to be that size,” Ms. Bramblette said. “I need to lose weight.”