Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia

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

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

Study Overview

• Status: Completed
• Conditions: Uric Acid
• Intervention / Treatment: Drug: Orlistat; Drug: Orlistat placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200070
      • Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orlistat group; Orlistat was administered orally on the basis of lifestyle guidance.	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.
Placebo Comparator: control group; Orlistat placebo was administered orally on the basis of lifestyle guidance.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Overnutrition; Nutrition Disorders; Body Weight; Overweight; Hyperuricemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents; Anti-Obesity Agents; Orlistat
• Other Study ID Numbers: orlistat reduces UA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No