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Efficacy and safety of IBI362 in overweight or obesity patients with hyperuricemia: a single center, randomized, double-blind, placebo-controlled trial

Efficacy and safety of IBI362 in overweight or obesity patients with hyperuricemia: a single center, randomized, double-blind, placebo-controlled, 2:1 parallel clinical study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049968
Enrollment
Unknown
Registered
2021-08-15
Start date
2021-08-16
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hyperuricemia

Interventions

group 1:IBI362 drug

Sponsors

The First Affiliated Hospital of Henan University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 60 years (including both ends), male or female; 2. Obese: BMI>=28.0kg/m2; or overweight: 24.0420umol/L; 4. Be able to understand the procedures and methods of this study, be willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. The investigator suspects that the subject may be allergic to the study drug or ingredient or similar drugs; 2. Weight change >5.0% controlled by simple diet and exercise for at least 12 weeks before screening (complaint); 3. Subjects with secondary hyperuricemia; 4. Previously diagnosed as gout; 5. Use of any of the following drugs or treatments before screening: GLP-1 receptor (GLP-1R) agonist or GLP-1R/GCGR agonist or GIPR/GLP-1R agonist or GIPR/GLP-1R agonist within 3 months before screening GIPR/GLP-1R/GCGR agonist; used uric acid-lowering drugs within 3 months before screening, including allopurinol, febuxostat, benzbromarone, etc.; used within 3 months before screening, which has an effect on body weight medications, including: systemic steroids (intravenous, oral, or intraarticular), tricyclic antidepressants, psychiatric medications, or sedatives (eg, imipramine, amitriptyline, mirtazapine) , paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, valproic acid derivatives, lithium salts), etc.; used within 3 months before screening. Chinese herbal medicines, health products, meal replacements, etc.; have used or are currently using weight loss drugs within 3 months before screening, such as: sibutramine hydrochloride, orlistat, phentermine, phenylpropanolamine, chlorbenzidine Indole, phentermine, bupropion, lorcaserin, phentermine/topiramate mixture, naltrexone/bupropion mixture, etc.; used hypoglycemic drugs within 3 months before screening, such as metformin, SGLT2 inhibitors, thiazolidinediones (TZDs), etc.; participated in other clinical trials within 3 months before screening (received experimental drug treatment); 6. History or evidence of any of the following diseases: HbA1c >= 6.5% at screening or previously diagnosed with type I or type II diabetes; fasting venous blood glucose >= 7.0 mmol/L at screening; Retinopathy in the past or at screening Patients; previous severe hypoglycemia or recurrent symptomatic hypoglycemia (>=2 times within half a year); secondary disease or drug-induced obesity, including: elevated cortisol hormones (eg: Cushing's syndrome), pituitary and hypothalamus Obesity due to injury, obesity due to reduction/discontinuation of diet pills, etc.; previous weight loss surgery (except for acupuncture weight loss, liposuction, and abdominal fat removal 1 year before screening); planned weight loss during the study period Surgery or acupuncture for weight loss, liposuction and abdominal fat removal, etc.; past history of moderate to severe depression; or past history of serious mental illness, such as schizophrenia, bipolar disorder, etc.; past suicidal tendencies or Suicidal behavior; uncontrolled hypertension within one month prior to screening, defined as: systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg (stable for 1 month if using antihypertensive drugs); previous or screening malignancy Medical history (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); previous myocardial infarction, angina pectoris, acute or chronic heart failure, cardiomyopathy, or percutaneous coronary intervention, coronary artery bypass grafting, etc. Cardiac surgery or echocardiography showed significantly abnormal cardiac function and was not suitable for participation in this study after investigator assessment; hemorrhagic or ischemic stroke or transient ischemic attack occurred within 6 months before screenin

Design outcomes

Primary

MeasureTime frame
uric acid;

Countries

China

Contacts

Public ContactJiang Hongwei

The First Affiliated Hospital of Henan University of Science and Technology

jianghw@haust.edu.cn+86 13653880139

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026