Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial
Primary result · Mean percent weight changeResult — go to the resultDifference −19.4 % 95% CI −21.2% to −17.7%Authors' conclusion
In participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction.
Study context
- Population
- Adults with BMI ≥30, or ≥27 with a weight-related complication, excluding diabetes, who completed a 36-week tirzepatide lead-in; mean age 48 years, 71% women, mean weight 107.3 kg783 in lead-in
- Participants
- 670 adults
- Comparison
- Continued tirzepatide vs switch to placebo
- Tirzepatiden = 335
- Placebon = 335reference
- Primary endpoint
- Mean percent change in weight from week 36 (randomization)
- Follow-up
- Week 88
Methodological detailsphase 3, randomized withdrawal, 36-week open-label lead-in, double-blind, placebo-controlled, 70 sites in 4 countries
- Phase 3
- Randomized withdrawal
- 36-week open-label lead-in
- Double-blind
- Placebo-controlled
- 70 sites in 4 countries
Primary result
Mean percent weight change · week 36 to week 88
Difference
−19.4 %
95% CI −21.2% to −17.7%
P < 0.001
Change by group
Tirzepatide
−5.5
mean · %
Placebo
14.0
mean · %
Tirzepatidevs Placebo
difference −19.4 % (95% CI −21.2% to −17.7%); P < 0.001
As reported in the abstract
Secondary outcomes
Maintained ≥80% of lead-in weight loss (key secondary) · week 88
P < 0.001
Mean, %
| Outcome | Tirzepatide | Placebo |
|---|---|---|
| Overall mean weight reduction · week 0 to 88 | 25.3 | 9.9 |
Mean weight reduction during lead-in · 36-week lead-in
- Mean weight reduction in participants completing lead-in
- 20.9%
Safety
Adverse events
- Most common AEs were mostly mild to moderate gastrointestinal events, more common with tirzepatide vs placebo
Original publication
Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. JAMA. Published 2 January 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →