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NCT Number: NCT07326839

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Northern Theater Command, PLA

Shenyang, Liaoning, 110016, China

Location contact

Ping Li, Ph D

CONTACT

[email protected]

02428853148

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Orlistat 120 mg

Drug

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

Other names: Orlistat 120 mg tid

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

  1. 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

Secondary outcomes

  1. 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).

  2. 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.

  3. the expression of AMPK-HIF1-inflammasome

    Time frame: 24 weeks

    changes in the expression of key molecules in the AMPK-HIF1-inflammasome axis.

Study contacts

Contact information is provided by the study sponsor or research team.

XueMei GUO, MS

CONTACT

[email protected]

+86-24-28853148

Sponsors and collaborators

Lead sponsor

XueMei Guo

Other

Collaborators

  • Shengjing Hospital
  • The People's Hospital of Liaoning Province

Registry information

Official study title

Optimization of Blood Uric Acid Control in Obese Gout Patients by Orlistat-Mediated Metabolic Remodeling and Intensive Weight Management: A Randomized Controlled Trial

Acronym: OWMUAC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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