Eli Lilly & Co. (LLY) Reports New Analyses of Mounjaro Injection for Treatment of Type 2 Diabetes

New data from a mechanism of action study and new analyses of the global registration program for Eli Lilly and Company's (NYSE: LLY) Mounjaro™ (tirzepatide) injection were presented at the American Diabetes Association's® (ADA) 82nd Scientific Sessions®, adding to the robust body of data about Mounjaro for the treatment of adults with type 2 diabetes. More than 20 presentations on Mounjaro were accepted for disclosure at the ADA's Scientific Sessions.

"Lilly is proud to present new mechanism of action data and new analyses of the results that Mounjaro delivered throughout the SURPASS program at the ADA's Scientific Sessions, helping us further evaluate how Mounjaro can help adults living with type 2 diabetes manage key aspects of their disease," said Laura Fernández Landó, MD, associate vice president, Medical, Lilly Diabetes. "Exploring factors such as how quickly Mounjaro can help lower A1C and weight, or the relationship between those two measures throughout the SURPASS program, is important as we begin to bring Mounjaro to people living with type 2 diabetes."

Mounjaro Mechanism of Action Study Additional results of a phase 1 mechanism of action study were presented in an oral presentation on Monday, June 6 during the "Incretin Based Therapies" session. This study was a 28-week, randomized, double-blind, parallel study to evaluate the effect of Mounjaro 15 mg compared to placebo and to injectable semaglutide 1 mg. The primary endpoint, previously disclosed, compared the effect of Mounjaro 15 mg versus placebo on total clamp disposition index at 28 weeks. The secondary objectives presented today at ADA compared the effects of Mounjaro 15 mg to placebo and to injectable semaglutide 1 mg on energy intake, appetite and body composition in adults with type 2 diabetes as measured by change from baseline.

At 28 weeks, participants taking Mounjaro (N=45) had significantly greater reductions in weight and in fat mass compared to those taking injectable semaglutide 1 mg (N=44) and placebo (N=28):

• Weight reduction: 11.2 kg (24.7 lb., Mounjaro 15 mg), 6.9 kg (15.2 lb., injectable semaglutide 1 mg) and 0 kg (placebo), p<0.001
• Fat mass reduction: 9.7 kg (21.4 lb., Mounjaro 15 mg) and 5.9 kg (13.0 lb., injectable semaglutide 1 mg), p=0.002

Further, treatment with Mounjaro 15 mg and injectable semaglutide 1 mg resulted in significant reductions from baseline in energy intake (-348.4 kcal and -284.1 kcal, respectively, p=0.187) as well as reductions in appetite ratings.

Relationship Between Body Weight Change and Glycemic Control with MounjaroResults from this post-hoc analysis of all five studies within the SURPASS global registration program were presented in a poster session. This analysis assessed the relationship between A1C and body weight reductions with Mounjaro treatment (5 mg, 10 mg or 15 mg) across the SURPASS-1 through -5 clinical trials. Results showed that between 87% and 97% of participants taking Mounjaro experienced both A1C and weight reductions.

Time to Reach Glycemic and Weight Targets with Tirzepatide Compared to Injectable Semaglutide 1 mg and Titrated Insulin DegludecResults from this exploratory analysis of SURPASS-2 and SURPASS-3 were shared in a poster session, evaluating the median time taken to achieve certain glycemic targets (i.e., median time to A1C <7% and ≤6.5%) and the median time taken to achieve at least 5% weight loss. The analysis compared the time to reach the A1C targets from baseline among participants treated with Mounjaro (5 mg, 10 mg and 15 mg) versus those treated with injectable semaglutide 1 mg (SURPASS-2) or those treated with titrated insulin degludec (SURPASS-3), and the time to reach the weight target among participants treated with Mounjaro or injectable semaglutide 1 mg. Participants taking all three doses of Mounjaro reached these A1C targets about four weeks sooner than those taking injectable semaglutide 1 mg, and between four weeks and 12 weeks sooner than those taking titrated insulin degludec.

Specifically, results showed:

• Median time to achieve A1C <7%: 8 weeks (Mounjaro), 12 weeks (injectable semaglutide 1 mg), 12 weeks (titrated insulin degludec)
• Median time to achieve A1C ≤6.5%: 12 weeks (Mounjaro), 16 weeks (injectable semaglutide 1 mg), 24 weeks (titrated insulin degludec)
• Median time to achieve ≥5% weight reduction: 12 weeks (Mounjaro 10 mg and 15 mg), 16 weeks (Mounjaro 5 mg), 24 weeks (injectable semaglutide 1 mg)

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