Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia

NCT05496075 | Completed Phase 4

• 1 other identifier: orlistat reduces UA
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Uric Acid

Outcome Measures

Primary Outcomes (1)

• level of uric acid

  Change from Baseline Uric acid at 3 months

  Month 3

Study Arms (2)

Orlistat group

EXPERIMENTAL

Orlistat was administered orally on the basis of lifestyle guidance.

Drug: Orlistat

control group

PLACEBO COMPARATOR

Orlistat placebo was administered orally on the basis of lifestyle guidance.

Drug: Orlistat placebo

Interventions

Orlistat DRUG

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 group

Orlistat placebo DRUG

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.

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.-

You may not qualify if:

• 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.-

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's hospital

Shanghai, Shanghai Municipality, 200070, China

Location

Related Publications (1)

• Liu S, Lin X, Tao M, Chen Q, Sun H, Han Y, Yang S, Gao Y, Qu S, Chen H. Efficacy and safety of orlistat in male patients with overweight/obesity and hyperuricemia: results of a randomized, double-blind, placebo-controlled trial. Lipids Health Dis. 2024 Mar 11;23(1):77. doi: 10.1186/s12944-024-02047-7.

  PMID: 38468241 DERIVED

MeSH Terms

Interventions

Orlistat

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 11, 2022
• Study Start: August 26, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

CN (1)