26% weight loss seen with tirzepatide in long-term SURMOUNT-3, SURMOUNT-4 trials
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Key takeaways:
- Adults with obesity lost 26.6% body weight with intensive lifestyle intervention followed by 72 weeks of tirzepatide.
- A mean weight loss of 26% was also achieved for adults receiving tirzepatide for 88 weeks.
Adults with obesity who used tirzepatide for 72 weeks after lifestyle intervention or continuously for 88 weeks achieved a mean weight loss of 26%, according to topline results from two SURMOUNT trials.
Eli Lilly announced preliminary findings from the SURMOUNT-3 and SURMOUNT-4 trials in a press release. In the trials, tirzepatide (Mounjaro, Eli Lilly) was associated with a mean weight loss of about 26% in both trials, with a safety profile similar to that previously reported in other SURMOUNT studies.
"The results of SURMOUNT-3 and -4 showed the highest level of weight loss observed in the SURMOUNT program to date," Jeff Emmick, MD, PhD, senior vice president of product development for Eli Lilly, said in a press release. "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."
In the SURMOUNT-3 trial, adults with obesity or overweight with weight-related comorbidities participated in a 12-week intensive lifestyle intervention. After the intervention, participants who lost at least 5% of their body weight were randomly assigned to receive tirzepatide or placebo for 72 weeks.
The SURMOUNT-3 cohort lost a mean 6.9% body weight during lifestyle intervention. During the 72-week treatment period, the tirzepatide group lost an additional 21.1% of body weight compared with a 3.3% weight gain for the placebo group in the efficacy estimand. Of adults receiving tirzepatide, 94.4% lost at least 5% body weight during the treatment period. From study entry to 84 weeks, the tirzepatide group lost a total of 26.6% body weight.
The SURMOUNT-4 trial enrolled adults with obesity or overweight with weight-related comorbidities to receive open-label tirzepatide during a 36-week lead-in period. After the lead-in period, participants were randomly assigned to either continue tirzepatide or switch to placebo for 52 weeks.
At the end of the lead-in period, participants achieved a mean weight loss of 21.1%. At 88 weeks, the tirzepatide group lost an additional 6.7% body weight according to the efficacy estimand compared with a 14.8% weight regain for placebo. Adults who remained on tirzepatide for the entire 88-week period lost a mean 26% of their body weight.
The safety profile for tirzepatide in both trials was similar to what was previously reported in SURMOUNT and SURPASS trials as well as other incretin-based therapies approved for overweight or obesity. Gastrointestinal-related adverse events were most common and were mostly mild to moderate in severity.
According to the release, the full results of SURMOUNT-3 will be presented at ObesityWeek, and the full results of SURMOUNT-4 will be presented at the European Association for the Study of Diabetes annual meeting, both taking place in October.
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