Insights from the SURMOUNT-4 Tirzepatide Clinical Trial
In the ongoing battle against obesity, a clinical trial has shed new light on the effectiveness of long-term medication use for weight management.
The SURMOUNT-4 trial, a phase 3 randomized withdrawal study, has recently unveiled compelling results that could reshape our approach to treating obesity and overweight conditions.
This extensive research, conducted across 70 sites in four countries, focused on the impact of tirzepatide on weight loss and maintenance in adults struggling with excess weight.
The study not only examined the drug’s initial effectiveness in promoting weight loss but also investigated the crucial question of what happens when treatment is continued versus discontinued.
With obesity rates climbing globally and the challenges of maintaining weight loss well-documented, the findings of this trial are particularly timely and relevant.
Let’s delve into the details of this study, exploring how it was conducted, what the researchers discovered, and what these results could mean for the future of obesity treatment.
Study Design and Participants
- Phase 3, randomized withdrawal clinical trial conducted at 70 sites in 4 countries
- 783 participants enrolled in a 36-week open-label tirzepatide lead-in period
- 670 participants randomized to continue tirzepatide (n=335) or switch to placebo (n=335) for 52 weeks
- Participants had a mean age of 48 years, 71% were women, and mean initial weight was 107.3 kg
Results
During the 36-week lead-in period, participants experienced a mean weight reduction of 20.9%
From weeks 36 to 88:
Tirzepatide group:
- additional 5.5% weight reduction
Placebo group:
- 14.0% weight regain
At week 88:
- 89.5% of tirzepatide group maintained at least 80% of initial weight loss
- 16.6% of placebo group maintained at least 80% of initial weight loss
Overall mean weight reduction from week 0 to 88:
- Tirzepatide group: 25.3%
- Placebo group: 9.9%
Safety
- Most common adverse events were mild to moderate gastrointestinal events
- Gastrointestinal events were more common in the tirzepatide group
Treatment discontinuation due to adverse events:
- 1.8% in tirzepatide group
- 0.9% in placebo group
Conclusion
The study concluded that in participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction.
Healthcare providers considering a medically-supervised weight management program for their practice should ensure they are sufficiently trained and certified in medical weight management prior to treating patients.
Source:
- Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity, https://jamanetwork.com/journals/jama/fullarticle/2812936
