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Zepbound ® (tirzepatide) injection
2.5 mg/ 5 mg/ 7.5 mg/ 10 mg/ 12.5 mg/ 15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Can Zepbound® (tirzepatide) be used in patients with gastroesophageal reflux disease (GERD)?
A preexisting condition of GERD was not a specific exclusion criterion for enrollment in the Zepbound clinical trials in adults with obesity or overweight.
See important safety information, including boxed warning, in the attached prescribing information.
Prescribing Information Related to Gastroesophageal Reflux Disease
The use of tirzepatide has been associated with gastrointestinal adverse reactions, sometimes severe. Tirzepatide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.1
In the pooled data from two placebo-controlled trials for weight reduction (SURMOUNT-1 and SURMOUNT-2) gastroesophageal reflux disease (GERD) was reported in
- 4% of participants treated with tirzepatide 5 mg
- 4% of participants treated with tirzepatide 10 mg
- 5% of participants with tirzepatide 15 mg
- 2% of participants treated with placebo.1
Use in Patients With Preexisting GERD
Participants were excluded from clinical trials for weight management if they had a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or were chronically taking drugs that directly affect gastrointestinal motility.2-5
A preexisting condition of gastroesophageal reflux disease (GERD) was not a specific exclusion criterion for enrollment in the SURMOUNT clinical program in adults with obesity or overweight.
No additional information is available because Eli Lilly and Company has not sponsored a subgroup analysis of SURMOUNT study participants with a preexisting condition of GERD.
Lilly cannot provide clinical recommendations on the use of tirzepatide in patients with GERD. The treating physician may use the information provided, the patient’s prior medical history and concomitant medications, and other individual factors, in formulating an assessment and approach. The treating physician should consider potential risks and benefits of treatment options and monitor appropriately.
Enclosed Prescribing Information
References
1Zepbound [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
2Jastreboff AM, Aronne LJ, Ahmad NN, et al; SURMOUNT-1 Investigators. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205-216. https://doi.org/10.1056/NEJMoa2206038
3Garvey WT, Frias JP, Jastreboff AM, et al; SURMOUNT-2 investigators. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023;402(10402):613-626. https://doi.org/10.1016/S0140-6736(23)01200-X
4Wadden TA, Chao AM, Machineni S, et al. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. 2023;29(11):2909-2918. https://doi.org/10.1038/s41591-023-02597-w
5Aronne LJ, Sattar N, Horn DB, et al; SURMOUNT-4 Investigators. Continued treatment with tirzepatide for maintenance of weight reduction in adults with obesity: the SURMOUNT-4 randomized clinical trial. JAMA. 2024;331(1):38-48. https://doi.org/10.1001/jama.2023.24945
Date of Last Review: November 20, 2024