Efficacy and safety of tirzepatide in people with obesity
Study design
- Phase 3 double-blind, randomized, controlled trial
Population
- Number of patients studied: 2539
- Inclusion criteria: Adults with BMI of 30 or more, or 27 or more and at least one weight-related complication, excluding diabetes
- Exclusion criteria: Presence of diabetes
Interventions
- Experimental group: Once-weekly, subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) for 72 weeks
- Control group: Placebo for 72 weeks
Primary outcome
- Percentage change in weight from baseline and a weight reduction of 5% or more
Safety outcomes or Adverse Events
- Adverse events in 78.9% to 81.8% of participants treated with tirzepatide, compared to 72.0% in the placebo group; most common were gastrointestinal events (nausea, diarrhea, and constipation)
Conclusion
- In this 72-week trial in participants with obesity, 5 mg, 10 mg, or 15 mg of tirzepatide once weekly provided substantial and sustained reductions in body weight.
References
- Jastreboff, A. M., Aronne, L. J., Ahmad, N. N., Wharton, S., Connery, L., Alves, B., Kiyosue, A., Zhang, S., Liu, B., Bunck, M. C., Stefanski, A., & SURMOUNT-1 Investigators. (2022). Tirzepatide once weekly for the treatment of obesity. New England Journal of Medicine, 387(3), 205–216. https://doi.org/10.1056/NEJMoa2206038