Data from the SURMOUNT-3 trial, presented at Obesity Week 2023, showed that use of tirzepatide (Mounjaro) led to an additional 21.1% average weight loss after 12 weeks of intensive lifestyle intervention in overweight or obese patients. suggests that they are related.
The results of this trial, which examined the use of tirzepatide compared to placebo therapy after a 12-week lifestyle intervention, showed that tirzepatide use was associated with a total mean weight loss of 26.6% from study entry to week 84 of the study. It suggests that there is.
“In this study, people who added tirzepatide to their diet and exercise had greater and longer-lasting weight loss than those who took a placebo,” said Eli Lilly and Company’s senior vice president of product development. said one Jeff Emick, MD.2 “Intensive lifestyle interventions are an important part of obesity management, but these results highlight the difficulty some people face in maintaining weight loss through diet and exercise alone. I am.”
Main highlights
- Tirzepatide in the SURMOUNT-3 trial: After 12 weeks of lifestyle intervention, an additional 21.1% weight loss by the end of the study.
- Total mean weight loss with tirzepatide: 26.6% from study start to week 84.
- The safety profile is consistent with other studies. Common adverse events include nausea, diarrhea, and constipation.
Tirzepatide has attracted the attention of the medical community since the results of the SURPASS program demonstrated the benefits of a GIP/GLP-1 dual receptor agonist in the management of type 2 diabetes. Just months after being approved for type 2 diabetes in May 2022, the drug made headlines with its 72-week SURMOUNT-1 results. This result provided evidence of the effects of tirzepatide on body weight in overweight or obese patients..3,4
SURMOUNT-3 was designed as a randomized, double-blind, placebo-controlled trial to compare tirzepatide with placebo for 72 weeks, followed by a 12-week intensive lifestyle intervention induction period. The study enrolled 806 overweight adults with obesity or weight-related comorbidities, excluding type 2 diabetes.1
In accordance with the study protocol, the intensive lifestyle intervention induction period included a low-calorie diet, exercise, and weekly counseling sessions. After a run-in period, participants who received the maximum tolerated dose of 10 mg or 15 mg of tirzepatide or placebo once weekly for 72 weeks and achieved a weight loss of 5.0% or more. A total of 579 participants participated in the randomized portion of the trial.1
The study’s secondary endpoints were the percent change in body weight at the end of the study due to randomization and the proportion of patients who lost 5% or more in weight from randomization to the end of the study.1
Treatment effect estimates show that tirzepatide use is associated with an additional 21.1% average weight loss after the run-in period, compared with 3.3% weight gain in the placebo group; The results showed that (estimated treatment difference) [ETD], -24.5 percentage points. 95% confidence interval [CI]−26.1 to −22.8. P< .001). Analysis of estimated treatment regimens suggested that the mean change in weight at week 72 was -18.4% with tirzepatide and 2.5% with placebo (ETD, -20.8 percentage points; 95% CI, -23.2 ～-18.5; P< .001).1
Further analysis of the co-primary endpoint showed that the proportion of participants who achieved an additional weight loss of 5% or more was achieved by 87.5% in the tirzepatide group, compared to 16.5% in the placebo group who achieved this threshold. (odds ratio, 34.6; 95% CI 19.2) up to 62.6. P< .001).1
The researchers noted that the safety profile observed in SURMOUNT-3 is consistent with other trials in the SURMOUNT and SURPASS programs. Specifically, the most common adverse events were nausea (tirzepatide: 39.7% vs. placebo: 14.0%), diarrhea (31.0% vs. 9.2%), constipation (23.0% vs. 6.8%), and COVID-19 (23.0%). % vs. 25.3%), and vomiting (18.1% vs. 1.4%). The researchers also noted that adverse events led to discontinuation in 10.5% of the tirzepatide group and 2.1% of the placebo group.1
References:
- Wadden TA, Chao AM, Machinini S et al. Tirzepatide after intensive lifestyle intervention in overweight or obese adults: SURMOUNT-3 phase 3 study [published online ahead of print, 2023 Oct 15]. Nat Med. 2023;10.1038/s41591-023-02597-w. doi:10.1038/s41591-023-02597-w
- Lilly’s tirzepatide demonstrated an additional 21.1% weight loss after 12 weeks of intensive lifestyle intervention, for a total average weight loss of 26.6% over the first 84 weeks of the study. Eli Lilly and Company. October 2023.
- Campbell P. Tirzepatide (Mounjaro) receives FDA approval for type 2 diabetes. HCP live. May 13, 2023. Accessed October 16, 2023. https://www.hcplive.com/view/tirzepatide-wins-fda-approval-for-type-2-diabetes.
- Campbell P. Tirzepatide further solidified its weight loss efficacy in the Sumount 3 and Sumount 4 trials. HCP live. July 27, 2023. Accessed October 16, 2023. https://www.hcplive.com/view/tirzepatide-furthers-cements-weight-loss-benefit-in-surmount-3-and-surmount-4-trials.
