Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia

Study Overview
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Brief Summary
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To clarify the uric acid-lowering efficacy of orlistat in overweight/obese patients with hyperuricemia, and to evaluate the safety of orlistat treatment

Official Title
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Observational Study on Clinical Efficacy and Safety of Orlistat in Reducing Uric Acid in Overweight/Obese Patients With Hyperuricemia

Conditions
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Uric Acid

Intervention / Treatment
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* Drug: Orlistat
* Drug: Orlistat placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (Items 1, 2, and 4 meet at the same time, and items 3 and 5 meet one of them) Obtain the informed consent of the subjects before any trial-related activities (including activities carried out to assess the eligibility of subjects); Men or women over the age of 18 at the time of screening; The diagnosis of hyperuricemia refers to the fasting of serum uric acid > 420umol/L (7 mg/dl) twice on different days under a normal purine diet. The weight meets the following requirements (a or b): a) BMI ≥ 25.0 kg/m2; b) waist circumference, female ≥ 85 cm, male ≥ 90 cm. Suffering from hyperuricemia and/or gout.- Exclusion Criteria: Use of drugs that may affect uric acid within 1 month before enrollment, including; benzbromarone, allopurinol, febuxostat, etc.; Abnormal liver function, ALT and AST are more than 2.5 times the upper limit of normal; Other diseases that affect glucose and lipid metabolism: hyperthyroidism, hypothyroidism, hypercortisolism, etc.; Diabetic patients with poor blood sugar control: HbA1c>7%; Chronic kidney disease or severe renal impairment, according to eGFR grading <45mL/min/1.73m2; The life expectancy does not exceed 5 years; Female subjects who are pregnant or plan to become pregnant within the next 24 weeks; Those who are expected to be unable to complete the intervention follow-up in other circumstances; If other drugs are used in combination, the drug dose should be kept stable for three months before enrollment; Participated in other clinical trials within the past 4 weeks; Use of drugs that affect body weight within 3 months before screening, including: systemic steroids (intravenous, oral or intra-articular), tricyclic antidepressants, psychiatric drugs or sedatives (eg, imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, valproic acid derivatives, lithium salt), etc.; Obesity caused by secondary diseases or drugs, including: elevated cortisol hormone (for example: Cushing's syndrome), obesity caused by pituitary and hypothalamus damage, obesity caused by reduction/discontinuation of weight loss drugs, etc.; Inability to complete the exercise and for other reasons, the researcher believes that it is not suitable to participate in this researcher.-

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orlistat group<br>Orlistat was administered orally on the basis of lifestyle guidance. | Drug: Orlistat<br>* Orlistat was administered orally on the basis of lifestyle guidance . Orlistat: Take 0.12g (1 capsule) with or within one hour after meals, 3 times a day. Medication time course: continuous administration for a total of 12 weeks.<br>|
| Placebo Comparator: control group<br>Orlistat placebo was administered orally on the basis of lifestyle guidance. | Drug: Orlistat placebo<br>* Lifestyle guidance: low-purine diet; orlistat placebo: take 1 capsule with or within one hour after a meal, 3 times a day. Medication time course: continuous administration for a total of 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of uric acid | Change from Baseline Uric acid at 3 months | Month 3 |