Lilly diabetes drug helps patients shed average of 34 pounds in trial
Eli Lilly and Co. said Thursday morning that a new clinical trial for its much-touted drug tirzepatide helped overweight diabetes patients lose an average of 15.7% of body weight, or 34.4 pounds, after 72 weeks.
The news is sure to boost interest in the drug, which is currently sold under the brand name Mounjaro for type 2 diabetes, as Americans increasingly look for a way to lose weight and manage diabetes, perhaps with a single medicine.
The Indianapolis-based drugmaker said it would complete submission of tirzepatide to the U.S. Food and Drug Administration in coming weeks for treatment of obesity and expects regulatory action as early as late 2023.
Separately, Lilly announced Thursday that Mounjaro rang up sales of $568 million in the first quarter for treatment of diabetes, putting it on pace to become a blockbuster drug this year.
Pre-market trading in Lilly soared $12.73, or 3.38% to an all-time high of $389 Thursday morning.
Lilly said first-quarter profits fell 29% to $1.34 billion, as revenue dipped 11%, mostly due to a $1.47 billion falloff in sales of COVID-19 antibodies.
Excluding COVID-19 antibodies, revenue in increased 10% in the quarter, driven by volume growth from Mounjaro, along with cancer drug Verzenio and diabetes drugs Jardiance and Trulicity.
After one-time adjustments, Lilly recorded first-quarter profit of $1.46 billion, down 38%.
Adjusted earnings per share were $1.62, falling short of Wall Street’s expectations. Analysts were expecting $1.73, according to Zacks Consensus Estimate.
Still, Lilly provided a rosy outlook, boosting full-year revenue guidance to a range of $31.2 billion to $31.7 billion, increased by $900 million, driven by updates to foreign exchange rate assumptions and underlying business performance.
It also boosted earnings per share guidance to a range of $8.18 to $8.38 on a reported basis and $8.65 to $8.85 on an adjusted basis.
But the big news of the day was the trial results for tirzepatide, which Lilly said achieved superior weight loss compared to treatment in testing on 938 adult patients with obesity or overweight and type 2 diabetes.
The trial, called SURMOUNT-2, is the second global phase 3 clinical trial that evaluated the effectiveness and safety of tirzepatide for chronic weight management.
Obesity is often a precursor to diabetes. Doctors warn their overweight patients to shed pounds or risk getting diabetes, a serious chronic disease that can lead to kidney disease, serious foot problems and blindness.
Even so, many patients fail to manage the disease, and lose their eyesight, lower limbs and kidney function. That’s because managing diabetes requires daily attention to diet and exercise, along with medicines that sometimes include insulin injections.
Diabetes costs the U.S. health system $147 billion a year, according to the U.S. Centers for Disease Control and Prevention.
The issue has grown to epidemic proportions, with more than 4 million people worldwide dying each year as a result of being overweight or obese.
Last year, Lilly said the drug in its initial trial, called SURMOUNT, helped patients in a large clinical trial lose up to 22.5% of body weight—or more than 50 pounds.
“Obesity is a difficult-to-manage disease, and it’s even more difficult for people living with type 2 diabetes,” said Dr. Jeff Emmick, a Lilly senior vice president, in written remarks. “The degree of mean weight reduction seen in SURMOUNT-2 has not been previously achieved in phase 3 trials for obesity or overweight and type 2 diabetes.”
Lilly originally developed tirzepatide to treat Type 2 diabetes, to help patients keep their blood sugar levels on an even keel.
The drug, a once-a-week injectable, is a peptide, or chain of amino acids, that works by activating the body’s receptors for two hormones called GIP and GLP-1. Those hormones stimulate insulin secretion, delay gastric emptying, suppress appetite and regulate blood lipid metabolism.
In the latest trial, participants taking tirzepatide achieved average weight reductions of 13.4% on 10 mg and 15.7% on 15 mg compared to placebo.
Lilly said tirzepatide also met all key secondary objectives, which included reduction in A1C and other cardiometabolic parameters.
Study participants had a mean baseline body weight of 222 lb. and baseline A1C of 8.0%, which is higher than the 7.0% recommended by the American Diabetes Association.