Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07326839

Opening soonNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionGout, Obesity

Full registry criteria

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.

Treatments and study arms

Orlistat 120 mg

Drug

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

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.

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.

Primary outcomes

The rate of patients achieving target serum uric acid levels24 weeks

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

General Hospital of Northern Theater Command, PLA🇨🇳 Shenyang, Liaoning, China

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Ping Li, Ph DContact

Email · Call 02428853148