GoutOWMUACNCT07326839
Orlistat and Weight Management for Uric Acid Control in Obese Gout: A RCT
A study testing Orlistat 120 mg, Allopurinol 100 up to 600mg/day and Febuxostat 40mg Tab in people with Gout and Obesity, run by XueMei Guo at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Orlistat 120 mg, Allopurinol 100 up to 600mg/day and Febuxostat 40mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2025to 9 Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
General Hospital of Northern Theater Command, PLA
Shenyang, Liaoning, 110016
Ping Li, Ph D, 02428853148, graceli008@sohu.com
About this study
Official title: Optimization of Blood Uric Acid Control in Obese Gout Patients by Orlistat-Mediated Metabolic Remodeling and Intensive Weight Management: A Randomized Controlled Trial
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.
Read the detailed description
This study employs a double-blind, randomized, controlled trial design. A total of 120 obese gout patients were included and randomly divided into two groups: the intervention group (60 cases): Orlistat (120 mg tid) + UTL + personalized dietary guidance, exercise prescription, and behavioral intervention for a duration of 24 weeks. The control group (60 cases): placebo + UTL + standard weight control recommendations, with the same intervention duration. Both groups received standard uric acid-lowering therapy (such as allopurinol or febuxostat) according to guidelines, with dosages adjusted based on blood uric acid levels and liver and kidney function to maintain stability.
Study Flow and Assessment Indicators Baseline Assessment: demographic data, medical history collection; physical examination (weight, BMI, waist circumference, etc.); laboratory tests (blood routine, urine routine, sedimentation rate, CRP, blood glucose, blood lipids, blood uric acid, liver and kidney function, etc.); collection of peripheral blood mononuclear cells (PBMCs) for mechanistic studies.
Follow-up Assessments (weeks 4, 12, 24): Clinical Indicators: changes in weight, liver and kidney function, blood lipid levels, blood uric acid levels, frequency of gout attacks.
Safety Indicators: recording of adverse events. Mechanistic Study Indicators: detection of AMPK activity in PBMCs, expression levels of HIF1α, NLRP3, ASC, caspase-1, IL-1β, and metabolomics analysis.
Statistics : SPSS 23.0; t-test/Mann-Whitney U for continuous variables, chi-square for categorical data.
- Being tested
- Orlistat 120 mg, Allopurinol 100 up to 600mg/day, Febuxostat 40mg Tab
- Keywords
- Obese, Gout, Orlistat, Metabolic Reprogramming, Weight Control, Uric acid, AMPK, HIF1, NLRP3
- Medical subject headings
- Gout, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orlistat 120 mgDrug
Also called Orlistat 120 mg tid
Oral capsule, taken after meals, 120 mg three times daily (tid) for 24 weeks.
Allopurinol 100 up to 600mg/dayDrug
Standard urate-lowering therapy (e.g., allopurinol or febuxostat), with doses adjusted based on serum uric acid levels and liver/kidney function.
Febuxostat 40mg TabDrug
Standard urate-lowering therapy (e.g., allopurinol or febuxostat), with doses adjusted based on serum uric acid levels and liver/kidney function.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Allopurinol 100 up to 600mg/day; Drug: Febuxostat 40mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients achieving target serum uric acid levels
The rate of patients achieving serum uric acid < 360 μmol/L
Measured: 24 weeks
Secondary outcomes (3)
changes in body weight
The proportion of patients with a weight loss of ≥5%,the unit of weight is Kilogram(Kg).
Measured: 24 weeks
inflammatory markers
changes in the frequency of gout attacks, changes in inflammatory markers (CRP, IL-1β, etc.).The unit of CRP is mg/L,the unit of ESR is mm/h,the unit of IL- 1β is pg/mL.
Measured: 24 weeks
the expression of AMPK-HIF1-inflammasome
changes in the expression of key molecules in the AMPK-HIF1-inflammasome axis.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start10 Dec 2025 (estimated)
- Primary completion9 Nov 2027 (estimated)
- Study completion9 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized open-label, two-arm parallel control
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XueMei Guo
- Sponsor type
- University, hospital or other
- Collaborators
- Shengjing Hospital, The People's Hospital of Liaoning Province
- Responsible party
- Sponsor-investigator, XueMei Guo, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326839
- Sponsor's protocol ID
- 2025JH2/101800052
- Acronym
- OWMUAC
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
China Obesity Research Collaborative Group.Standardized Reporting for Combined Intervention Studies in Metabolic Diseases (2024 Edition)
Chinese Rheumatology Association, Chinese Medical Association.Ethical Requirements for Clinical Trial Registration in Gout Diagnosis and Treatment Guidelines (2025 Edition)
Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University.Operational Guidelines for Chinese Clinical Trial Registry (2023 Edition)
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.
PubMed 17053334Liu 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.
PubMed 38468241Yip 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.
PubMed 35342538Sridharan 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.
PubMed 39835962Chen 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.
PubMed 36388084Chinese 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
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.
PubMed 33399399Larsson 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.
PubMed 30085130Guo 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.
PubMed 31870173Do 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.
PubMed 37993515Afinogenova 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.
PubMed 34907116Wei 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.
PubMed 39300602