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Retatrutide-Obesity
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling.
Was dysesthesia reported as an adverse event in the retatrutide TRIUMPH trials in patients with overweight or obesity?
Dysesthesia occurred more frequently with retatrutide than with placebo in the completed TRIUMPH phase 3 trials. Events were generally mild to moderate.
What was the incidence of dysesthesia in the retatrutide phase 3 TRIUMPH trials?
In the TRIUMPH trials, dysesthesia was defined as a skin burning sensation and related adverse events. Incidence rates reported by dose in TRIUMPH-1, TRIUMPH-2, TRIUMPH-3, and TRIUMPH-4 are shown in Table 1.1-4
Across the phase 3 TRIUMPH trials, dysesthesia was reported at higher incidence with retatrutide than with placebo. Dysesthesia events were mostly mild to moderate in severity.1-4
Table 1. Incidence of Dysesthesia in the Phase 3 TRIUMPH Trials1-4
Trial (Population) |
Placebo |
Retatrutide 4 mg |
Retatrutide 9 mg |
Retatrutide 12 mg |
|---|---|---|---|---|
TRIUMPH-1 (obesity/overweight without diabetes) |
1 % |
5 % |
12 % |
13% |
TRIUMPH-2 |
1% |
4% |
6% |
7% |
TRIUMPH-3 |
1% |
NA |
6% |
6% |
TRIUMPH-4 |
1% |
NA |
9% |
21% |
Abbreviations: CVD = cardiovascular disease; NA = non-applicable; T2D = type 2 diabetes.
Note: A 4 mg dose was not evaluated in TRIUMPH-3 or TRIUMPH-4 (target doses were 9 mg and 12 mg).
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Jastreboff AM, Kaplan LM, Davies MJ, et al. Retatrutide, a triple hormone receptor agonist for treatment of obesity. N Engl J Med. Epub ahead of print September 29, 2026. https://doi.org/10.1056/NEJMoa2604169
- Bellido V, le Roux C, Ekinci E, et al. Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial. Lancet. Epub ahead of print September 29, 2026. https://doi.org/10.1016/S0140-6736(26)01861-1
- Eli Lilly and Company. Lilly’s triple agonist, retatrutide, successful in two additional Phase 3 obesity trials, delivering significant improvements in weight and A1C [press release]. July 23, 2026. Accessed August 18, 2026. https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-successful-two-additional
- Eli Lilly and Company. Lilly’s triple agonist, retatrutide, delivered weight loss of up to an average of 71.2 lbs along with substantial relief from osteoarthritis pain in first successful phase 3 trial [press release]. December 11, 2025. Accessed August 18, 2026. https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-delivered-weight-loss-average
Date of Last Review: August 18, 2026