Gastrointestinal tolerability and weight reduction associated with tirzepatide in adults with obesity or overweight with and without type 2 diabetes in the SURMOUNT ‐1 to ‐4 trials
Authors' conclusion
In this post hoc analysis, GI AEs appeared to contribute slightly to the weight reduction seen with tirzepatide in participants with obesity or overweight with or without T2D.
Study context
- Population
- Adults with obesity or overweight with or without T2D (SURMOUNT-1 to −4)
- Comparison
- Once-weekly subcutaneous tirzepatide vs placebo
- Primary endpoint
- Weight change from baseline at the primary endpoint among participants self-reporting no N/V/D, any N/V/D or nausea alone
- Follow-up
- Primary endpoint
Methodological detailsglobal, phase 3, placebo-controlled, mediation analysis
- Global
- Phase 3
- Placebo-controlled
- Mediation analysis
Primary result
As reported in the abstract
N/V/D and dyspepsia associated with share of total weight reduction (mediation analyses)
up to 3.1%
Further findings
Baseline characteristics
- Similar between participants reporting N/V/D and those who did not
Safety
| Outcome | Tirzepatide | Placebo |
|---|---|---|
| GI AEs | 27.8%-72.8% | 12.2%-32.5% |
- Discontinuation due to gastrointestinal (GI) adverse events (AEs) — Tirzepatide · range across tirzepatide-treated participants
- 1.0% and 10.5%
GI AEs
- Most GI AEs non-serious and occurred during dose escalation
Antidiarrheal and antiemetic use
- First use most commonly during dose escalation
Original publication
Gastrointestinal tolerability and weight reduction associated with tirzepatide in adults with obesity or overweight with and without type 2 diabetes in the SURMOUNT ‐1 to ‐4 trials. Diabetes Obes Metab. Published 9 January 2025. doi:10. 1111/ dom. 16176
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