NCT05496075CompletedPhase 4
Observational Study on Clinical Efficacy and Safety of Orlistat in Reducing Uric Acid in Overweight/Obese Patients With Hyperuricemia
Shanghai 10th People's Hospital1 site in 1 country72 target enrollmentStarted: August 26, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- level of uric acid
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.-
Arms & Interventions
Orlistat group
Experimental
Orlistat was administered orally on the basis of lifestyle guidance.
Intervention: Orlistat (Drug)
control group
Placebo Comparator
Orlistat placebo was administered orally on the basis of lifestyle guidance.
Intervention: Orlistat placebo (Drug)
Outcomes
Primary Outcomes
level of uric acid
Time Frame: Month 3
Change from Baseline Uric acid at 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Zhang Manna
Deputy Chief Physician
Shanghai 10th People's Hospital
Study Sites (1)
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