Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia
Primary Purpose
Uric Acid
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Orlistat
Orlistat placebo
Sponsored by
About this trial
This is an interventional treatment trial for Uric Acid
Eligibility Criteria
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.-
Sites / Locations
- Shanghai Tenth People's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Orlistat group
control group
Arm Description
Orlistat was administered orally on the basis of lifestyle guidance.
Orlistat placebo was administered orally on the basis of lifestyle guidance.
Outcomes
Primary Outcome Measures
level of uric acid
Change from Baseline Uric acid at 6 months
Secondary Outcome Measures
Full Information
NCT ID
NCT05496075
First Posted
August 8, 2022
Last Updated
October 18, 2022
Sponsor
Shanghai 10th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05496075
Brief Title
Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia
Official Title
Observational Study on Clinical Efficacy and Safety of Orlistat in Reducing Uric Acid in Overweight/Obese Patients With Hyperuricemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2022 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
February 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uric Acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Orlistat group
Arm Type
Experimental
Arm Description
Orlistat was administered orally on the basis of lifestyle guidance.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Orlistat placebo was administered orally on the basis of lifestyle guidance.
Intervention Type
Drug
Intervention Name(s)
Orlistat
Intervention Description
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 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Orlistat placebo
Intervention Description
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 24 weeks.
Primary Outcome Measure Information:
Title
level of uric acid
Description
Change from Baseline Uric acid at 6 months
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.-
Facility Information:
Facility Name
Shanghai Tenth People's hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hang Sun, MD
Phone
86-21-66301004
Email
sunhang1027@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia
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