Orlistat and Weight Management for Uric Acid Control in Obese Gout: A RCT

Summary

A total of 120 obese gout patients were included in a 24-week double-blind randomized controlled design. The intervention group received orlistat 120 mg tid + UTL + individualized diet-exercise-behavioral reinforcement weight loss program, while the control group received a placebo + UTL + standard recommendations. The primary endpoint was the rate of achieving serum uric acid levels \<360 μmol/L at 24 weeks; secondary endpoints included the proportion of weight loss ≥5%, frequency of gout attacks, and inflammatory indicators such as CRP and IL-1β; the activity of AMPK in PBMCs and the expression of HIF1α and NLRP3 inflammasome-related proteins were also assessed.

Timeline

Start

2025-12-10

Primary completion

2027-11-09

Completion

2027-11-09

Publications

• Background China Obesity Research Collaborative Group.Standardized Reporting for Combined Intervention Studies in Metabolic Diseases (2024 Edition)
• Background Chinese Rheumatology Association, Chinese Medical Association.Ethical Requirements for Clinical Trial Registration in Gout Diagnosis and Treatment Guidelines (2025 Edition)
• Background Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University.Operational Guidelines for Chinese Clinical Trial Registry (2023 Edition)
• Results Beutel ME, Dippel A, Szczepanski M, Thiede R, Wiltink J. Mid-term effectiveness of behavioral and psychodynamic inpatient treatments of severe obesity based on a randomized study. Psychother Psychosom. 2006;75(6):337-45. doi: 10.1159/000095439.
• Results Liu S, Lin X, Tao M, Chen Q, Sun H, Han Y, Yang S, Gao Y, Qu S, Chen H. Efficacy and safety of orlistat in male patients with overweight/obesity and hyperuricemia: results of a randomized, double-blind, placebo-controlled trial. Lipids Health Dis. 2024 Mar 11;23(1):77. doi: 10.1186/s12944-024-02047-7.
• Results Yip ASY, Leong S, Teo YH, Teo YN, Syn NLX, See RM, Wee CF, Chong EY, Lee CH, Chan MY, Yeo TC, Wong RCC, Chai P, Sia CH. Effect of sodium-glucose cotransporter-2 (SGLT2) inhibitors on serum urate levels in patients with and without diabetes: a systematic review and meta-regression of 43 randomized controlled trials. Ther Adv Chronic Dis. 2022 Mar 23;13:20406223221083509. doi: 10.1177/20406223221083509. eCollection 2022.
• Results Sridharan K, Alkhidir MMOH. Hypouricemic effect of sodium glucose transporter-2 inhibitors: a network meta-analysis and meta-regression of randomized clinical trials. Expert Rev Endocrinol Metab. 2025 Mar;20(2):139-146. doi: 10.1080/17446651.2025.2456504. Epub 2025 Jan 21.
• Results Chen X, Chen S, Ren Q, Niu S, Pan X, Yue L, Li Z, Zhu R, Jia Z, Chen X, Zhen R, Ban J. Metabolomics Provides Insights into Renoprotective Effects of Semaglutide in Obese Mice. Drug Des Devel Ther. 2022 Nov 9;16:3893-3913. doi: 10.2147/DDDT.S383537. eCollection 2022.
• Results Chinese Society of Endocrinology. Guidelines for long-term weight management and clinical application of drugs in obese patients (2024 edition). Chin J Endocrinol Metab. 2024;40(7):545-564. doi:10.3760/cma.j.cn311282-20240412-00149
• Results Yokose C, McCormick N, Choi HK. The role of diet in hyperuricemia and gout. Curr Opin Rheumatol. 2021 Mar 1;33(2):135-144. doi: 10.1097/BOR.0000000000000779.
• Results Larsson SC, Burgess S, Michaelsson K. Genetic association between adiposity and gout: a Mendelian randomization study. Rheumatology (Oxford). 2018 Dec 1;57(12):2145-2148. doi: 10.1093/rheumatology/key229.
• Results Guo G, Dong C, Yin R, Yang Y, Zhao R, Wang Y, Guo J, Zhou W, Lu G. Serum urate goal attainment and associated factors in Chinese gout patients. Psychol Health Med. 2020 Sep;25(8):931-939. doi: 10.1080/13548506.2019.1706751. Epub 2019 Dec 23.
• Results Do H, Choi HJ, Choi B, Son CN, Kim SH, Choi SR, Kim JH, Kim MJ, Shin K, Kim HO, Song R, Lee SW, Ahn JK, Lee SG, Lee CH, Son KM, Moon KW. Factors for achieving target serum uric acid levels after initiating urate-lowering therapy in patients with gout: results from the ULTRA registry. Sci Rep. 2023 Nov 22;13(1):20511. doi: 10.1038/s41598-023-47790-6.
• Results Afinogenova Y, Danve A, Neogi T. Update on gout management: what is old and what is new. Curr Opin Rheumatol. 2022 Mar 1;34(2):118-124. doi: 10.1097/BOR.0000000000000861.
• Results Wei J, Wang Y, Dalbeth N, Xie J, Wu J, Zeng C, Lei G, Zhang Y. Weight Loss After Receiving Anti-Obesity Medications and Gout Among Individuals With Overweight and Obese: A Population-Based Cohort Study. Arthritis Rheumatol. 2025 Mar;77(3):335-345. doi: 10.1002/art.42996. Epub 2024 Nov 11.

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