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NCT05496075CompletedPhase 4

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

Source: ClinicalTrials.gov · Last updated 14 Dec 2023

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
72 (actual)
First submitted
8 Aug 2022
Start date
26 Aug 2022
Primary completion date
1 Dec 2023
Lead sponsor
Shanghai 10th People's Hospital
Diseases
Obesity
NCT number
NCT05496075

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 72
  • From 26 Aug 2022 to the primary completion date, 1 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of drugs that may affect uric acid within 1 month before enrollment, including; benzbromarone, allopurinol, febuxostat, etc.;
  • If other drugs are used in combination, the drug dose should be kept stable for three months before enrollment;
  • 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.;

Other illness

  • 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.;

Lab values

  • 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;

Other

  • 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;
  • Participated in other clinical trials within the past 4 weeks;
  • Inability to complete the exercise and for other reasons, the researcher believes that it is not suitable to participate in this researcher.-

Who the study is looking for

  • (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.-

Age in the registry: 18 years to 65 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Shanghai Tenth People's Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.