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MENS WEIGHT LOSS TRACKER TEMPLATE TRIAL

The starting dose of 2.5 mg tirzepatide was increased by 2.5 mg every four weeks until maximum tolerated dose was achieved. SURMOUNT-3 utilized a maximum tolerated dose of 10 mg or 15 mg once-weekly. The co-primary objectives of the study were to demonstrate that tirzepatide is superior in percent change in body weight from randomization and percentage of participants achieving ≥5% body weight reduction from randomization at 72 weeks compared to placebo. After 12 weeks, 579 participants achieved at least 5% body weight reduction and were randomized in a 1:1 ratio to receive tirzepatide or placebo.

MENS WEIGHT LOSS TRACKER TEMPLATE TRIAL

The trial enrolled 806 participants across the U.S., including Puerto Rico, Argentina and Brazil to a lead-in period with intensive lifestyle intervention. SURMOUNT-3 (NCT04657016) was a multi-center, randomized, double-blind, parallel, placebo-controlled trial comparing the efficacy and safety of tirzepatide to placebo for 72 weeks after a 12-week intensive lifestyle intervention lead-in period in adults with obesity or overweight with weight-related comorbidities, excluding type 2 diabetes. Adverse events led to discontinuation of study treatment in 10.5% of participants taking tirzepatide and 2.1% taking placebo.Ībout SURMOUNT-3 and the SURMOUNT clinical trial program 1

The most frequent events reported by those on tirzepatide compared with placebo, respectively, were nausea (39.7% vs. The most commonly reported adverse events in SURMOUNT-3 were gastrointestinal-related and generally mild to moderate in severity. The overall safety profile of tirzepatide in SURMOUNT-3 was similar to previously reported SURMOUNT and SURPASS trials. *Tested for superiority, controlled for type 1 error. 'While intensive lifestyle intervention is an important part of obesity management, these results underscore the difficulty some people face maintaining weight loss with diet and exercise alone.' 'In this study, people who added tirzepatide to diet and exercise saw greater, longer-lasting weight reduction than those taking placebo,' said Jeff Emmick, MD, Ph.D., senior vice president, product development, Lilly. Participants on placebo achieved a total mean weight loss of 3.8% (4.1 kg or 9.0 lb.) from study entry over 84 weeks. In a secondary endpoint, participants achieved a total mean weight loss of 26.6% (29.2 kg or 64.4 lb.) from study entry over 84 weeks. At the end of the 12-week lead-in period, participants achieved 6.9% (7.6 kg or 16.8 lb.) mean weight loss. In a co-primary endpoint, following the lead-in period, participants taking tirzepatide achieved an additional 21.1% mean weight loss. At study entry, the mean body weight was 241.4 lb. The trial randomized adults with obesity or overweight who had at least 5% body weight reduction by the end of the 12-week lead-in period to placebo or tirzepatide.

SURMOUNT-3 evaluated the efficacy and safety of tirzepatide compared to placebo for 72 weeks after a 12-week intensive lifestyle intervention lead-in period that included a low-calorie diet, exercise and frequent counseling sessions. Tirzepatide met both co-primary endpoints for the efficacy estimand i and treatment-regimen ii estimand, demonstrating superiority to placebo during the 72-week double-blind treatment period. 15, 2023 /PRNewswire/ - Detailed results from Eli Lilly and Company's (NYSE: LLY) phase 3 SURMOUNT-3 clinical trial evaluating tirzepatide in adults with obesity or overweight with weight-related comorbidities, excluding type 2 diabetes, were published in Nature Medicine and simultaneously presented at ObesityWeek ® 2023.

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The full results of the SURMOUNT-3 trial were published in Nature Medicine and simultaneously presented at ObesityWeek ® 2023

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