JAMA
Stopping tirzepatide leads to weight regain: SURMOUNT-4 trial results
Among participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight loss.
- The phase 3, randomized SURMOUNT-4 trial was conducted at 70 sites in 4 countries and included a 36-week, open-label tirzepatide lead-in period followed by a 52-week, double-blind, placebo-controlled period involving adults with a BMI ≥30, or ≥27 and a weight-related complication, excluding diabetes. Participants (n = 783) enrolled in an open-label lead-in period received once-weekly SC maximum tolerated dose (10 or 15 mg) of tirzepatide for 36 weeks. At week 36, a total of 670 participants were randomized (1:1) to continue receiving tirzepatide (n = 335) or switch to placebo (n = 335) for 52 weeks.
- Participants (n = 670; mean age, 48 years; 71% women; mean weight, 107.3 kg) who completed the 36-week lead-in period experienced a mean weight reduction of 20.9%. Mean percent weight change from week 36 to week 88 was −5.5% with tirzepatide vs. 14.0% with placebo (difference, −19.4%; 95% confidence interval [CI], −21.2% to −17.7%]; P < .001). At 88 weeks, 89.5% of tirzepatide recipients maintained at least 80% of the weight loss during the lead-in period vs. 16.6% of placebo recipients (P < .001). Overall mean weight reduction from week 0 to 88 was 25.3% for tirzepatide vs. 9.9% for placebo. The most common adverse events were mostly mild to moderate GI events, which occurred more commonly in the tirzepatide group.
Source:
Aronne LJ, et al. (2023, December 11). JAMA. Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. https://pubmed.ncbi.nlm.nih.gov/38078870/