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Tirzepatide demonstrated significant and superior weight loss in two pivotal studies

Eli Lilly and Company (NYSE: LLY) announced the results of two phase 3 tirzepatide studies in adults with obesity or overweight with weight-related comorbidities, excluding type 2 diabetes. SURMOUNT-3 and SURMOUNT-4 met all primary and key secondary objectives for tirzepatide compared to placebo. Across SURMOUNT-3 and SURMOUNT-4, participants on tirzepatide following intensive lifestyle intervention or with continued tirzepatide treatment, achieved up to 26.6% mean weight loss, for the efficacy estimands.

The overall safety profile of tirzepatide in both studies was similar to previously reported SURMOUNT and SURPASS trials and to that of incretin-based therapies approved for the treatment of obesity and overweight. The most commonly reported adverse events in both trials were gastrointestinal-related and generally mild to moderate in severity.

"The results of SURMOUNT-3 and -4 showed the highest level of weight loss observed in the SURMOUNT program to date," said Jeff Emmick, MD, Ph.D., senior vice president, of product development, Lilly. "Whether taking tirzepatide for 88 weeks in SURMOUNT-4 or taking tirzepatide for 72 weeks following intensive caloric restriction in SURMOUNT-3, participants achieved similar mean weight reduction — about 26%. The findings from SURMOUNT-3 challenge the notion that patients living with obesity or overweight can achieve their weight loss goals with diet and exercise alone. Additionally, the findings from SURMOUNT-4 reinforce that obesity should be regarded like other chronic diseases where chronic therapy may be needed to maintain treatment benefits."

At a glance:

  • Participants in SURMOUNT-3, after 12 weeks of intensive lifestyle intervention, achieved an additional 21.1% mean weight loss with tirzepatide for a total mean weight loss of 26.6% from study entry over 84 weeks
  • Participants in SURMOUNT-4 achieved 21.1% weight loss during a 36-week tirzepatide lead-in period and an additional 6.7% weight loss during a 52-week continued treatment period, for a total mean weight loss of 26.0% over 88 weeks