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

January 7, 2026 updated by: XueMei Guo

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • General Hospital of Northern Theater Command, PLA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the experimental Group
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
Oral capsule, taken after meals, 120 mg three times daily (tid) for 24 weeks.
Other Names:
  • Orlistat 120 mg tid
Drug: Allopurinol 100 up to 600mg/day
Standard urate-lowering therapy (e.g., allopurinol or febuxostat), with doses adjusted based on serum uric acid levels and liver/kidney function.
Drug: Febuxostat 40mg Tab
Standard urate-lowering therapy (e.g., allopurinol or febuxostat), with doses adjusted based on serum uric acid levels and liver/kidney function.
Placebo Comparator: The control group
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
Standard urate-lowering therapy (e.g., allopurinol or febuxostat), with doses adjusted based on serum uric acid levels and liver/kidney function.
Drug: Febuxostat 40mg Tab
Standard urate-lowering therapy (e.g., allopurinol or febuxostat), with doses adjusted based on serum uric acid levels and liver/kidney function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of patients achieving target serum uric acid levels
Time Frame: 24 weeks
The rate of patients achieving serum uric acid < 360 μmol/L
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in body weight
Time Frame: 24 weeks
The proportion of patients with a weight loss of ≥5%,the unit of weight is Kilogram(Kg).
24 weeks
inflammatory markers
Time Frame: 24 weeks
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.
24 weeks
the expression of AMPK-HIF1-inflammasome
Time Frame: 24 weeks
changes in the expression of key molecules in the AMPK-HIF1-inflammasome axis.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XueMei Guo

Collaborators

Shengjing Hospital
The People's Hospital of Liaoning Province

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 10, 2025

Primary Completion (Estimated)

November 9, 2027

Study Completion (Estimated)

November 9, 2027

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025JH2/101800052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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