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Completed

NCT Number: NCT05496075

Orlistat Reduces 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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Tenth People's hospital

Shanghai, Shanghai Municipality, 200070, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.-

Treatment and study plan

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 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.

Primary outcomes

  1. level of uric acid

    Time frame: Month 3

    Change from Baseline Uric acid at 3 months

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 11, 2022
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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