Patients who took Eli Lilly‘s weight reduction drug tirzepatide lost as much as 34 kilos on average, or 16% of their body weight, the corporate said in clinical trial results released Thursday.
Eli Lilly plans to finish its application for Food and Drug Administration approval of the drug in the approaching weeks and expects regulatory motion as early as later this 12 months. The FDA approved tirzepatide for Type 2 diabetes last 12 months, however the drug is just not cleared for weight reduction.
The approval would open “up the chance for a lot of more people to profit from tirzepatide,” Eli Lilly CEO David Ricks said Thursday on CNBC’s “Squawk Box.” He added that the drug sets a “recent bar for weight reduction and other people with diabetes.”
The information come as firms attempt to capitalize on increased consumer demand for weight reduction treatments. Some experts have criticized the increased use of the drugs as a potentially damaging extension of weight loss program culture.
The phase three trial followed 938 adults who were chubby and had Type 2 diabetes. Patients who took a ten milligram version of the injection after 72 weeks lost nearly 30 kilos on average, while those that took 15 milligrams lost 34 kilos on average.
Patients within the placebo group who didn’t receive the injection lost a mean of seven kilos.
About 86% of patients within the trial who took tirzepatide lost at the very least 5% of their body weight, compared with about 30% within the placebo group.
A pharmacist displays a box of Mounjaro, a tirzepatide injection drug used for treating type 2 diabetes and made by Lilly at Rock Canyon Pharmacy in Provo, Utah, May 29, 2023.
George Frey | Reuters
The extent of average weight reduction seen within the trial “has not been previously achieved in phase 3 trials for obesity or chubby and kind 2 diabetes,” Jeff Emmick, Eli Lilly’s senior vp of product development, said in a press release.
Tirzepatide also reduced levels of A1C, which measures the body’s average blood sugar level over the past three months. Elevated levels of A1C are related to a better risk of diabetes complications.
Eli Lilly said it would proceed to observe results from the trial. The corporate will present the findings at an American Diabetes Association conference in June and submit the research to a peer-reviewed journal.
The load reduction within the trial is “substantial and highly clinically meaningful,” Dr. Robert Gabbay, the ADA’s chief scientific and medical officer, said in a press release
Gabbay said the burden loss was lower than what was reported in a previous clinical trial on tirzepatide, which examined the drug in patients who’ve obesity but shouldn’t have diabetes. Patients who took tirzepatide in that 2022 trial lost as much as 22.5% of their body weight.
But Gabbay said the difference in weight reduction between the brand new trial and the nondiabetes trial is consistent with other weight reduction medication research.
Drugs like tirzepatide and rival Novo Nordisk‘s Ozempic and Wegovy catapulted to the national highlight in recent times for being weight reduction “miracles.”
Social media influencers, Hollywood celebrities and even billionaire tech mogul Elon Musk have reportedly used the favored injections to eliminate unwanted weight.
But experts say the medicines may further perpetuate a dangerous weight loss program culture that idealizes weight reduction and thinness.
Some patients who stop taking the drugs also complain a couple of weight rebound that’s difficult to regulate.
Tirzepatide works by mimicking two naturally produced hormones within the gut called GLP-1 and GIP. The hormones signal to the brain when an individual is full, suppressing their appetite.
Ozempic and Wegovy only goal GLP-1. Patients who took Ozempic in a 2021 clinical trial lost nearly 15% of their body weight.
Eli Lilly earlier this month registered a recent clinical trial that may pit tirzepatide against Wegovy in 700 patients who’ve obesity or are chubby with weight-related health conditions. The corporate expects to finish the study in 2025.