A pharmacist displays a box of Mounjaro, an injectable tirzepatide drug for type 2 diabetes made by Eli Lilly and Company, at the Rock Canyon Pharmacy in Provo, Utah, May 29, 2023.
George Frey | Reuters
patients who have taken Eli LillyThe weight loss drug tezepatide lost an average of 34 pounds, or 16 percent of body weight, the company said clinical trial results Posted Thursday.
Eli Lilly plans to finalize the drug’s Food and Drug Administration approval application in the coming weeks and expects regulatory action as early as later this year.US Food and Drug Administration officially recognized tirzepatide was launched last year for type 2 diabetes, but the drug is not approved for weight loss.
Eli Lilly CEO David Ricks said on CNBC’s “Squawk Box” on Thursday that the approval would provide “more people with the opportunity to benefit from tirzepatide.” He added that the drug “sets a new standard for people with weight loss and diabetes.”
The data comes as companies try to capitalize on growing consumer demand for weight loss treatments. Some experts have criticized the increased use of these drugs as a potentially damaging extension of food culture.
The phase III trial followed 938 overweight adults with type 2 diabetes. Patients who received the 10 mg injection lost an average of nearly 30 pounds after 72 weeks, while those who received the 15 mg injection lost an average of 34 pounds.
Patients in the placebo group who did not take the drug lost an average of 7 pounds.
About 86 percent of patients in the trial who took tirzepatide lost at least 5 percent of their body weight, compared with about 30 percent of the placebo group
The level of average weight loss seen in the trial was “not previously achieved in a phase 3 trial targeting obesity or overweight and type 2 diabetes,” Jeff Emmick, Lilly’s senior vice president of product development, said in a statement. .
Tirzepatide also reduces Glycated hemoglobin, which measures the average blood sugar level of a person over the past three months. Higher levels of A1C are associated with a higher risk of diabetes complications.
Lilly said it will continue to monitor the trial results.Company to Present Study Results at American Diabetes Association Meeting June, and submit the study to a peer-reviewed journal.
The weight loss in the trial was “substantial and highly clinically relevant,” ADA chief scientific and medical officer Dr. Robert Gabbay said in a statement
Gabbay said weight loss was lower than previously reported clinically trial Regarding tirzepatide, it examines the drug in patients who are obese but not diabetic. Patients taking tirzepatide in the 2022 trial lost 22.5 percent of their body weight.
But Gabbay said the difference in weight loss between the new trial and the non-diabetic trial was consistent with other weight-loss drug studies.
Medications like tirzepatide and competitors Novo NordiskIn recent years, Ozempic and Wegovy have garnered attention as weight-loss “miracles.”
Social media influencers, Hollywood celebrities and even billionaire tech moguls Elon Musk They reportedly use the popular injection method to shed excess pounds.
but experts explain These drugs may further perpetuate a dangerous eating culture that idealizes weight loss and thinness.
Some patients who stop taking the drug also complain of unmanageable weight regain.
Tirzepatide works by mimicking two naturally occurring hormones, GLP-1 and GIP, in the gut. When a person is full, hormones signal the brain to curb their appetite.
Ozempic and Wegovy target GLP-1 only.Patients taking Ozempic 2021 Clinical Trials Lost almost 15% of my body weight.
Lilly registered a new clinical trials This will compare tirzepatide with Wegovy in 700 patients who are obese or overweight and have weight-related health problems. The company expects to complete the study by 2025.