Uric AcidPhase 4NCT05496075
Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia
A Phase 4 study testing Orlistat in people with Uric Acid, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
To clarify the uric acid-lowering efficacy of orlistat in overweight/obese patients with hyperuricemia, and to evaluate the safety of orlistat treatment Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Uric Acid
- What is being tested?
- Orlistat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2022to 1 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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.-
Who cannot join
- 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;
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- 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.-
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's hospital
Shanghai, Shanghai Municipality, 200070
About this study
Official title: Observational Study on Clinical Efficacy and Safety of Orlistat in Reducing 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
- Conditions
- Uric Acid
- Being tested
- Orlistat, Orlistat placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrlistatDrug
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 placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Orlistat group | Experimental | Orlistat was administered orally on the basis of lifestyle guidance. Receives: Drug: Orlistat |
| control group | Placebo comparator | Orlistat placebo was administered orally on the basis of lifestyle guidance. Receives: Drug: Orlistat placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of uric acid
Change from Baseline Uric acid at 3 months
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start26 Aug 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uric AcidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Manna, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496075
- Sponsor's protocol ID
- orlistat reduces UA
- Status last verified
- Dec 2023
- First submitted
- 8 Aug 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38468241
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Clinical Efficacy and Safety of Orlistat in Reducing Uric Acid in Overweight/Obese Patients With Hyperuricemia
- ClinicalTrials.gov ID
- NCT05496075
- Acronym / sponsor ID
- orlistat reduces UA
- Conditions
- Uric Acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orlistat group | Experimental | Drug: OrlistatOrlistat was administered orally on the basis of lifestyle guidance. |
| control group | Placebo comparator | Drug: Orlistat placeboOrlistat placebo was administered orally on the basis of lifestyle guidance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrlistatOrlistat 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. | Drug | Orlistat group |
| Orlistat placeboLifestyle 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. | Drug | control group |
Primary outcome
level of uric acid
Time frame: Month 3
Change from Baseline Uric acid at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Derived from this study: PubMed 38468241Liu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Orlistat in people with Uric Acid, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of uric acid (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05496075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.