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Compound monograph · evidence extract

Mazdutide in obesity and overweight in adults — evidence extract

The Institute's graded assessment of Mazdutide for obesity and overweight in adults, with the contributing trials and the domain-by-domain certainty reasoning.

Document identifier
CEI-MN-014/EV-OBESITY
Series
Evidence extract
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

§1Evidence extract: Obesity and overweight in adults

§1.1Question and anchor outcome

Population
Excess adiposity sufficient to impair health, operationalised in the pivotal incretin programmes as a body-mass index of 30 kg/m² or above, or 27 kg/m² or above with at least one weight-related comorbidity.
Intervention
Mazdutide, subcutaneous once weekly
Comparator
As used in each contributing trial; reported per trial rather than pooled across comparator types
Anchor outcome
Percentage change in body weight from baseline

Additional outcomes the Institute extracts for this indication: Proportion achieving ≥5 %, ≥10 %, ≥15 % and ≥20 % weight reduction; Change in waist circumference; Change in systolic blood pressure; Change in high-sensitivity C-reactive protein.

§1.2Contributing trials

Table 1. Trials contributing to the assessment of Mazdutide in obesity and overweight in adults.

TrialPhaseDesignRandomisedDurationYear
GLORY-13Randomised, double-blind, placebo-controlled61048 weeks2025
DREAMS-13Randomised, double-blind, placebo-controlled31924 weeks2024
MAZ-PH2-OBESITY2Randomised, double-blind, placebo-controlled24824 weeks2023

§1.3Certainty assessment

Certainty assessment by domainDowngrading decision recorded for each certainty domain.Certainty domainNo concernSeriousVery seriousEffect on ratingRisk of biasno downgradeInconsistencyno downgradeIndirectnessno downgradeImprecisionno downgradePublication biasdowngrade one levelTotal downgrading: 1 levelModerate certainty
Figure 2. Domain-by-domain certainty assessment for Mazdutide in obesity and overweight in adults. The starting rating for a body of randomised evidence is high; each serious concern reduces it by one level and each very serious concern by two.

Table 2. Reasoning recorded against each certainty domain.

DomainRatingReasoning
Risk of biasNo concernNo serious concern identified in this domain.
InconsistencyNo concernNo serious concern identified in this domain.
IndirectnessNo concernNo serious concern identified in this domain.
ImprecisionNo concernNo serious concern identified in this domain.
Publication biasSeriousThe evidence base is small, recent and wholly sponsor-generated.
Overall rating: Moderate certainty. The true effect is likely to be close to the estimate, but there is a possibility that it is substantially different. Further research is likely to have an important impact on confidence in the estimate.

§1.4What this extract does not establish

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.

  1. 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
  2. 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
  3. le Roux CW, Steen O, Lucas KJ, Startseva E, Unseld A, Hennige AM. Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial. The Lancet Diabetes & Endocrinology 2024;12(3):162–173. doi:10.1016/S2213-8587(23)00356-X · PMID 38330977

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