An interventional study of Orlistat 120 mg and Allopurinol 100 up to 600mg/day in Gout and Obesity, sponsored by XueMei Guo. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by XueMei Guo · Not applicable, Interventional, and Treatment
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.
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.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
This study's planned enrollment of 120 is above the median of 83 across 286 interventional studies indexed under Gout.
Browse Gout studies →This is the only study on the registry with XueMei Guo as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: Allopurinol 100 up to 600mg/day · Drug: Febuxostat 40mg Tab
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 · Drug: Febuxostat 40mg Tab
Oral capsule, taken after meals, 120 mg three times daily (tid) for 24 weeks.
Also known as: Orlistat 120 mg tid
Standard urate-lowering therapy (e.g., allopurinol or febuxostat), with doses adjusted based on serum uric acid levels and liver/kidney function.
Standard urate-lowering therapy (e.g., allopurinol or febuxostat), with doses adjusted based on serum uric acid levels and liver/kidney function.
The rate of patients achieving target serum uric acid levels
The rate of patients achieving serum uric acid \< 360 μmol/L
Time frame: 24 weeks
changes in body weight
The proportion of patients with a weight loss of ≥5%,the unit of weight is Kilogram(Kg).
Time frame: 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.
Time frame: 24 weeks
the expression of AMPK-HIF1-inflammasome
changes in the expression of key molecules in the AMPK-HIF1-inflammasome axis.
Time frame: 24 weeks
Plan to share: No
Start is estimated for Dec 2025; primary completion for Nov 2027, 22 months later.
Of 34 non-industry interventional studies with no phase under Gout, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 22 months is below that.
Counting every sponsor, half of 35 studies reached it within 29 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Orlistat