Compound monograph · §4

Mazdutide — safety

Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.

Document identifier: CEI-MN-014/4
Series: Compound monograph
Version: 3.1
Published: 22 Feb 2025
Last reviewed: 22 Jun 2026
Next review: 22 Jun 2028
Identifier: 10.71829/cei.mono.14
Certainty: Moderate
Cycle: 2025 Q1

§4Safety

§4.1Adverse events reported in controlled trials

Table 4. Adverse events for Mazdutide as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.

Event	Active, %	Comparator, %	Difference, pp	Source
Nausea	32.0	8.0	+24.0	Phase 3 obesity (6 mg)
Diarrhoea	22.0	9.0	+13.0	Phase 3 obesity
Vomiting	16.0	2.0	+14.0	Phase 3 obesity
Increased heart rate	—	—	—	Reported; attributed to the glucagon arm
Discontinuation for adverse events	5.0	2.0	+3.0	Phase 3 obesity
A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here.

Figure 4. Gastrointestinal adverse events for Mazdutide as reported in the contributing safety tables. Incidences of this kind are dose- and titration-rate-dependent and attenuate with continued exposure in most but not all participants.

§4.2Contraindications

As for the incretin class in the approving jurisdiction

§4.3Warnings and precautions

Glucagon receptor agonism with associated heart-rate effect
Evidence base is geographically concentrated, which limits generalisation

§4.4What this section does not establish

What this document does not establish

Rare events. A trial programme of the size available for this compound could not detect an event occurring at a rate below approximately one in several hundred exposed participants. The absence of such an event in the tables above is uninformative, not reassuring.
Long-latency events. The longest randomised exposure in the contributing evidence is measured in months to a small number of years. Outcomes with a longer latency are outside what any contributing trial could observe.
Harms of the supplied material as distinct from the compound. Every incidence above was measured in a trial using material manufactured under a regulated quality system. Harms attributable to impurities, counter-ion load, endotoxin or incorrect content in research-supply material are not represented in any of these figures.

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

Ji L, Jiang H, Bi Y, Li X, Ning G, Qu S, Wu Y, Yang J, Chen L, Li L, Zhang M, Qian L. Efficacy and safety of mazdutide in Chinese participants with overweight or obesity: a randomised, double-blind, placebo-controlled phase 2 trial. Diabetes, Obesity and Metabolism 2023;25(12):3691–3700. doi:10.1111/dom.15264
Müller TD, Finan B, Bloom SR, D’Alessio D, Drucker DJ, Flatt PR, Fritsche A, Gribble F, Grill HJ, Habener JF, Holst JJ, Langhans W, Meier JJ, Nauck MA, Perez-Tilve D, Pocai A, Reimann F, Sandoval DA, Schwartz TW, Seeley RJ. Glucagon-like peptide 1 (GLP-1). Molecular Metabolism 2019;30:72–130. doi:10.1016/j.molmet.2019.09.010 · PMID 31767182

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.

Compound Evidence Institute · CEI-MN-014/4 · https://compoundevidence.com/monographs/mazdutide/safety/ · retrieved 30 July 2026