Obesity

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 MetabPublished Post hoc analysis of the SURMOUNT-1 to −4 randomised 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

OutcomeTirzepatidePlacebo
GI AEs27.8%-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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