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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05496075
Other study ID # orlistat reduces UA
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 26, 2022
Est. completion date December 1, 2023

Study information

Verified date December 2023
Source Shanghai 10th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: (Items 1, 2, and 4 meet at the same time, and items 3 and 5 meet one of them) 1. Obtain the informed consent of the subjects before any trial-related activities (including activities carried out to assess the eligibility of subjects); 2. Men or women over the age of 18 at the time of screening; 3. 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. 4. The weight meets the following requirements (a or b): a) BMI = 25.0 kg/m2; b) waist circumference, female = 85 cm, male = 90 cm. 5. Suffering from hyperuricemia and/or gout.- Exclusion Criteria: 1. Use of drugs that may affect uric acid within 1 month before enrollment, including; benzbromarone, allopurinol, febuxostat, etc.; 2. Abnormal liver function, ALT and AST are more than 2.5 times the upper limit of normal; 3. Other diseases that affect glucose and lipid metabolism: hyperthyroidism, hypothyroidism, hypercortisolism, etc.; 4. Diabetic patients with poor blood sugar control: HbA1c>7%; 5. Chronic kidney disease or severe renal impairment, according to eGFR grading <45mL/min/1.73m2; 6. The life expectancy does not exceed 5 years; 7. Female subjects who are pregnant or plan to become pregnant within the next 24 weeks; 8. Those who are expected to be unable to complete the intervention follow-up in other circumstances; 9. If other drugs are used in combination, the drug dose should be kept stable for three months before enrollment; 10. Participated in other clinical trials within the past 4 weeks; 11. 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.; 12. 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.; 13. Inability to complete the exercise and for other reasons, the researcher believes that it is not suitable to participate in this researcher.-

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Orlistat
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.
Orlistat placebo
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.

Locations

Country Name City State
China Shanghai Tenth People's hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary level of uric acid Change from Baseline Uric acid at 3 months Month 3
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