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

NCT07326839 | Not Yet Recruiting

• 1 other identifier: 2025JH2/101800052
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gout; Obesity

Keywords

Obese; Gout; Orlistat; Metabolic Reprogramming; Weight Control; Uric acid; AMPK; HIF1; NLRP3

Outcome Measures

Primary Outcomes (1)

• The rate of patients achieving target serum uric acid levels

  The rate of patients achieving serum uric acid \< 360 μmol/L

  24 weeks

Secondary Outcomes (3)

• changes in body weight

  24 weeks

• inflammatory markers

  24 weeks

• the expression of AMPK-HIF1-inflammasome

  24 weeks

Study Arms (2)

the experimental Group

EXPERIMENTAL

The experimental Group received orlistat 120mg tid+ standard ULT (e.g., febuxostat 40mg qd) + basic lifestyle advice (low-purine diet and exercise guidance).

Drug: Orlistat 120 mg; Drug: Allopurinol 100 up to 600mg/day; Drug: Febuxostat 40mg Tab

The control group

PLACEBO COMPARATOR

The control group received placebo matching orlistat (tid) + standard ULT (e.g., febuxostat 40mg qd) + basic lifestyle advice (low-purine diet and exercise guidance).

Drug: Allopurinol 100 up to 600mg/day; Drug: Febuxostat 40mg Tab

Interventions

Orlistat 120 mg DRUG

Oral capsule, taken after meals, 120 mg three times daily (tid) for 24 weeks.

Also known as: Orlistat 120 mg tid

the experimental Group

Allopurinol 100 up to 600mg/day DRUG

Standard urate-lowering therapy (e.g., allopurinol or febuxostat), with doses adjusted based on serum uric acid levels and liver/kidney function.

The control group; the experimental Group

Febuxostat 40mg Tab DRUG

Standard urate-lowering therapy (e.g., allopurinol or febuxostat), with doses adjusted based on serum uric acid levels and liver/kidney function.

The control group; the experimental Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the 2015 ACR/EULAR classification criteria for gout.
• Age 18-70 years.
• BMI ≥28 kg/m².
• Serum uric acid ≥480 μmol/L.
• Willing and able to comply with the study protocol.

You may not qualify if:

• Contraindications to orlistat or other gout medications.
• Severe hepatic or renal dysfunction.
• History of severe allergy or adverse reactions to study drugs.
• Pregnant or lactating women.
• Malignancy.
• Secondary gout.
• Poor compliance or inability to cooperate.
• Participation in other clinical trials within the last 3 months.

Sponsors & Collaborators

• XueMei Guo: lead
• Shengjing Hospital: collaborator
• The People's Hospital of Liaoning Province: collaborator

Study Sites (1)

General Hospital of Northern Theater Command, PLA

Shenyang, Liaoning, 110016, China

Location

Related Publications (15)

• 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)

  BACKGROUND

• 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.

  PMID: 17053334 RESULT

• 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.

  PMID: 38468241 RESULT

• 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.

  PMID: 35342538 RESULT

• 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.

  PMID: 39835962 RESULT

• 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.

  PMID: 36388084 RESULT

• 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

  RESULT

• 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.

  PMID: 33399399 RESULT

• 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.

  PMID: 30085130 RESULT

• 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.

  PMID: 31870173 RESULT

• 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.

  PMID: 37993515 RESULT

• 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.

  PMID: 34907116 RESULT

• 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.

  PMID: 39300602 RESULT

MeSH Terms

Conditions

Gout; Obesity

Interventions

Orlistat; Febuxostat

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

XueMei GUO, MS

CONTACT

+86-24-28853148; 490422665@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: General Hospital of Shenyang Military Region

Model Details: Randomized open-label, two-arm parallel control

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 8, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): November 9, 2027
• Study Completion (Estimated): November 9, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)