Patients on experimental obesity drug have lost more than 50 pounds, says manufacturer

An experimental drug allowed obese or overweight people to lose about 22.5% of their body weight, 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 nevertheless surprised medical experts.

“Wow (and a double Wow!),” wrote Dr. Sekar Kathiresan, chief executive of Verve Therapeutics, a company focused on drugs for heart disease, wrote in a tweet. Drugs like Eli Lilly’s, he added, “will really revolutionize the treatment of obesity!!!”

Dr. Kathiresan has no ties to Eli Lilly or the drug.

Dr. Lee Kaplan, an obesity specialist at Massachusetts General Hospital, said the drug’s effect “appears to be significantly better than any other anti-obesity drug currently available in the US.” .”

Dr. Kaplan, who consults for a dozen pharmaceutical companies, including Eli Lilly, said he was not involved in the new trial or 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 greater.)

At the end of the study, those who took 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 only seen in surgical patients.

Some study participants lost enough weight to fall into the normal range, said Dr. Louis J. Aronne, director of the Weill Cornell Medical Center’s comprehensive weight management program, who worked with Eli Lilly as the study’s principal investigator.

Most people in the study did not qualify 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 type 2 diabetes. The risk of developing diabetes is often higher. higher for people with obesity than for people without it.

As obesity is a chronic medical condition, patients would need to take tirzepatide for life, as they do with blood pressure or cholesterol medications, for example.

Dr. Robert F. Kushner, an obesity specialist at Northwestern University’s Feinberg School of Medicine and a paid consultant to Novo Nordisk, said the new drug, along with a similar but less effective one from Novo Nordisk, could close a so-called treatment gap.

Diet and exercise, combined with previous obesity medications, usually produce 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 are ineligible or simply don’t want the surgery.

With Eli Lilly’s drug and Novo Nordisk’s semaglutide, which was recently approved, “we are really on the cusp of a new form of treatment,” said Dr. Kushner.

But prices can be a barrier. Insurers generally do not pay for weight loss medications. The Novo Nordisk drug, branded as Wegovy, has a list price of $1,349.02 a month.

Experts fear that tirzepatide, if approved, could be priced in the same range. Many people who could benefit most from weight loss may not be able to afford these expensive drugs.

The Eli Lilly study lasted 72 weeks and involved 2,539 participants. Many qualified as obese, while others were overweight but also had risk factors such as high blood pressure, high cholesterol levels, cardiovascular disease or obstructive sleep apnea.

They were divided into four groups. All received dietary advice to reduce calorie intake by about 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 themselves with the drug once a week.

Those who took the highest dose lost more weight, the researchers found. Participants who took a placebo lost 2.4% of their weight, 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 exciting time for her.

“I don’t think I ever imagined that we could achieve this degree of weight loss with a drug,” she said. “We only got this far with the surgery.”

For decades, overweight or obese people were told that solving the problem was up to them. Diet and exercise were the prescriptions, and they just didn’t work for many people. Most have tried diet after diet, just to regain the lost weight.

Last year, the situation began to change when Novo Nordisk received approval from the Food and Drug Administration to market semaglutide. The drug can cause weight loss of 15% to 17% in people with obesity.

The drugs are among a new class of drugs called incretins, which are natural 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 kind of weight loss possible with drugs. But they also pose difficult questions about whether bariatric surgery is becoming a relic of the past. There are already new versions of incretins in development that could be even more powerful than the drug Eli Lilly.

Even without them, said Dr. Aronne, the reductions seen with the drug Eli Lilly are “almost in the range of surgical weight loss.”

Some patients who have had bariatric surgery describe mixed results. Sarah Bramblette, a board member of the Obesity Action Coalition, had bariatric surgery just to regain the weight.

Now 44 years old, she weighed 500 pounds when she was operated on 20 years ago, which allowed her to reach 250 pounds. Over the years though, her weight has returned to 490 pounds. She needed heart surgery, but she was too heavy for the operating table. Diets – and she tried them over and over again – didn’t help.

Novo Nordisk’s semaglutide allowed her to reach 430 pounds. Now, said Mrs. Bramblette, she would like to try the Eli Lilly drug if it becomes available.

“Trust me, I wouldn’t choose to be that big,” Bramblette said. “I need to lose weight.”

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