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Clinical Research

Effects of tirzepatide on weight management in patients with and without diabetes: a systematic review and meta-analysis

International Journal of Obesity (2025)Cite this article

Subjects

Abstract

Aims

To conduct a systematic review and meta-analysis comparing tirzepatide versus placebo for weight management, with analyses stratified by diabetes status to precisely assess its efficacy and safety in individuals with and without diabetes.

Methods

We systematically searched MEDLINE, Embase, and Cochrane Library for randomized controlled trials comparing once-weekly tirzepatide (5–15 mg) versus placebo in adults with or without diabetes for at least 26 weeks. For each subpopulation analysis, the random-effects model was used to calculate pooled risk ratios (RRs) and mean differences (MDs), with their 95% confidence intervals, for dichotomous and continuous endpoints, respectively. Statistical significance was considered at p < 0.05.

Results

We included five trials (n = 2,174) in patients with diabetes (BMI ≥ 23 kg/m2) and five (n = 4,467) in patients without diabetes (BMI ≥ 27 [≥24 in Asia] kg/m2). Compared with placebo, tirzepatide led to significantly greater relative and absolute weight reductions in patients with (RR −9.54%, p < 0.01; MD −9.06 kg, p < 0.01) and without diabetes (RR −17.15%, p < 0.01; MD −18.11 kg, p < 0.01). In both subpopulations, tirzepatide also significantly increased the probability of achieving weight reductions of ≥5%, ≥10%, and ≥15%, as well as improved BMI, waist circumference, blood pressure, hemoglobin A1c, and lipid levels. Notably, weight-related benefits with tirzepatide were significantly greater in patients without diabetes, whereas its safety was similar across subpopulations and predominantly consisted of mild to moderate, well-tolerated adverse events.

Conclusions

Compared with placebo, tirzepatide resulted in statistically significant and clinically meaningful weight reduction, especially in patients without diabetes (with overweight/obesity), with an acceptable safety profile.

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Fig. 1: Graphical summary of pooled mean differences (95%CI) comparing tirzepatide versus placebo for changes in body weight (relative and absolute), body mass index, and waist circumference, stratified by diabetes status.

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Authors and Affiliations

  1. Department of Medicine, Universidade Evangélica de Goiás, Anápolis, Brazil

    Eduardo Cerchi

  2. Diagnostic Imaging and Specialized Diagnosis Unit, Hospital Universitário da Universidade Federal de São Carlos, São Carlos, Brazil

    Paula Arruda do Espírito Santo

  3. Department of Endocrinology, Universidade de Araraquara, Araraquara, Brazil

    Mariana Carvalho de Oliveira

  4. Clinical and Epidemiological Research Center, Universidade de São Paulo, São Paulo, Brazil

    Carolina Castro Porto Silva Janovsky

  5. Department of Endocrinology, Obesity Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil

    Bruno Halpern

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Contributions

EC: design, conduct/data collection, analysis, writing manuscript. PAES: design, conduct/data collection, analysis. MCO: conduct/data collection, analysis. CCPSJ: design, analysis, writing manuscript. BH: design, analysis, writing manuscript.

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Correspondence to Eduardo Cerchi.

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Competing interests

BH is on the Advisory Board of Novo Nordisk, Eli-Lilly, Astra Zeneca, Merck S/A, and received speaker honoraria from Novo Nordisk, Eli-Lilly, Astra Zeneca, Boehringer Ingelheim, Merck S/A and Abbott Nutrition. BH is Primary Investigator in BrTrials, and has conducted clinical trials by Eli-Lilly, Novo Nordisk and Boehringer Ingelheim. EC, PAES, MCO, and CCPSJ have no conflicts of interest to declare.

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Cerchi, E., Santo, P.A.d.E., de Oliveira, M.C. et al. Effects of tirzepatide on weight management in patients with and without diabetes: a systematic review and meta-analysis. Int J Obes (2025). https://doi.org/10.1038/s41366-025-01920-4

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