patients who have taken Eli Lilli‘s weight-loss drug, Tirzepatide, lost an average of up to 34 pounds, or 16% of her body weight, the company said in clinical trial results released Thursday.
Eli Lilly plans to complete its application for approval of the drug by the Food and Drug Administration in the coming weeks, and expects regulatory action later this year. The FDA approved tirzepatide for type 2 diabetes last year, but the drug isn’t approved for weight loss.
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The approval would “open up the opportunity for many more people to benefit from tirzepatide,” Eli Lilly CEO David Ricks said on CNBC’s “Squawk Box” on Thursday. He added that the drug sets a “new bar for weight loss and people with diabetes.”
The data comes as companies seek to capitalize on increased consumer demand for weight loss treatments. Some experts have criticized the increased use of the drugs as a potentially harmful extension of diet culture.
The phase 3 study followed 938 adults who were overweight and had type 2 diabetes. Patients who took a 10-milligram version of the injection lost an average of almost 30 pounds after 72 weeks, while those who took 15 milligrams lost an average of 34 pounds.
Patients in the placebo group who did not receive the injection lost an average of 7 pounds.
Around 86% of the patients in the study taking tirzepatide lost at least 5% of their body weight, compared with around 30% in the placebo group.
A pharmacist displays a box of Mounjaro, a tirzepatide injection drug used to treat type 2 diabetes, manufactured by Lilly at the Rock Canyon Pharmacy in Provo, Utah May 29, 2023.
George Frey | Reuters
The level of mean weight loss observed in the study “has not been reached previously in Phase 3 studies for obesity or overweight and type 2 diabetes,” said Jeff Emmick, Eli Lilly’s senior vice president of product development. in a statement.
Tirzepatide also reduced levels of A1C, which measures the body’s average blood sugar levels over the past three months. Elevated A1C levels are associated with a higher risk of diabetes complications.
Eli Lilly said it will continue to monitor the results of the study. The company will present the findings at an American Diabetes Association conference in June and will submit the research to a peer-reviewed journal.
The weight loss in the study was “substantial and clinically highly meaningful,” said Dr. Robert Gabbay, the ADA’s chief scientific and medical officer, in a statement
According to Gabbay, the weight loss was less than what was reported in an earlier clinical trial of tirzepatide, which looked at the drug in patients with obesity but not diabetes. Patients taking tirzepatide in this 2022 study lost up to 22.5% of their body weight.
But Gabbay said the difference in weight loss between the new study and the non-diabetes study is consistent with other weight loss drug research.
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Drugs like Tirzepatid and Rivale Novo Nordisk‘s Ozempic and Wegovy have catapulted themselves into the national limelight in recent years for being “weight loss miracles.”
Social media influencers, Hollywood celebrities and even billionaire tech mogul Elon Musk have reportedly used the popular injections to shed unwanted weight.
But experts say the drugs could further perpetuate a dangerous diet culture that idealizes weight loss and thinness.
Some patients who stop taking the medication also complain of weight gain that is difficult to control.
Tirzepatide works by mimicking two hormones naturally produced in the gut called GLP-1 and GIP. The hormones signal the brain when a person is full and suppress their appetite.
Ozempic and Wegovy only target GLP-1. Patients taking Ozempic lost nearly 15% of their body weight in a 2021 clinical trial.
Eli Lilly earlier this month registered a new clinical trial that will test tirzepatide versus Wegovy in 700 obese or overweight patients with weight-related health problems. The company expects to complete the study in 2025.