Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia

Phase 4

Completed

• Conditions: Uric Acid
• Interventions: Drug: Orlistat placebo; Drug: Orlistat

• Registration Number: NCT05496075
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-11
• Study Start: 2022-08-26
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Orlistat placebo	Orlistat placebo was administered orally on the basis of lifestyle guidance.
Orlistat group	Orlistat	Orlistat was administered orally on the basis of lifestyle guidance.

Primary Outcome Measures

Name	Time	Method
level of uric acid	Month 3	Change from Baseline Uric acid at 3 months

Trial Locations

Locations (1)

Shanghai Tenth People's hospital; 🇨🇳 Shanghai, Shanghai, China