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

XueMei Guo

Status: Not yet enrolling

Conditions: Obesity; Gout

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07326839

2025JH2/101800052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

the experimental Group

Experimental group

Description:

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

Treatment:

Drug: Orlistat 120 mg

Drug: Febuxostat 40mg Tab

Drug: Allopurinol 100 up to 600mg/day

The control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Febuxostat 40mg Tab

Drug: Allopurinol 100 up to 600mg/day