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The evaluation for the efficacy and safety of glucagon-like peptide 1 receptor agonist based on obesity phenotypes and the establishment of prediction models by machine learning

The evaluation for the efficacy and safety of glucagon-like peptide 1 receptor agonist based on obesity phenotypes and the establishment of prediction models by machine learning

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095509
Enrollment
Unknown
Registered
2025-01-08
Start date
2023-12-25
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Overweight and obesity

Interventions

Cerebral obesity:Treated with semaglutide subcutaneous injection. The starting dose is 0.25 mg weekly. 2 weeks to 0.5 mg per week. 4 weeks to 1 mg per week. After that, the maximum tolerated dose is g
Gastrointestinal obesity:Treated with semaglutide subcutaneous injection. The starting dose is 0.25 mg weekly. 2 weeks to 0.5 mg per week. 4 weeks to 1 mg per week. After that, the maximum tolerated d
Emotional obesity:Treated with semaglutide subcutaneous injection. The starting dose is 0.25 mg weekly. 2 weeks to 0.5 mg per week. 4 weeks to 1 mg per week. After that, the maximum tolerated dose is
Slow metabolic obesity:Treated with semaglutide subcutaneous injection. The starting dose is 0.25 mg weekly. 2 weeks to 0.5 mg per week. 4 weeks to 1 mg per week. After that, the maximum tolerated dos

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age 18 years and above, BMI>=28kg/m^2, male or female; 2) Have not use GLP-1RA or have used GLP-1RA but have stopped taking it for 6 months or more; 3) Have not undergone weight loss surgery, have not used other drugs that may cause weight change (such as orlistat, metformin, sodium-glucose cotransporter 2 inhibitors, insulin, etc.) or have been using these drugs for 6 months or more; 4) After assessment by the researchers, they can cooperate with the relevant tests in the study, or complete face-to-face follow-up or telephone follow-up under the supervision of relatives/guardians; 5) Women with fertility potential at screening must have a negative serum (ß-human chorionic cells) gonadotropin [ß-hCG] test, that is, a negative urine pregnancy test at screening; 6) Women meet the following criteria: a.No fertility potential: premenstrual; Permanent sterilization (e.g. tubal obstruction, hysterectomy, bilateral salpingectomy); Or can't get pregnant; b.Consent to the continued use of highly effective birth control methods throughout the trial; 7) The subject must sign an informed consent form (ICF) indicating that he or she understands the purpose and procedures required for the study and is willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1) Contraindications of GLP-1RA: a. Allergy to any of the ingredients in the GLP-1RA class of drugs used in the study; b. Type 1 diabetes mellitus or diabetic ketoacidosis; c. Patients with a prior or family history of medullary thyroid cancer and patients with type 2 multiple endocrine tumor syndrome; d. Patients with inflammatory bowel disease and diabetic gastroparesis; e. Patients with acute pancreatitis; 2) Pregnant and lactating women; 3) Poor blood glucose control, HbA1c>=10%, accompanied by obvious symptoms of hyperglycemia (polydipsia, polyphagia, polyuria, weight loss) or secondary acute complications of diabetes in the past 1 month; 4) Having a serious systemic disease may cause the physical condition of the subjects to deteriorate during the study period or the safety of the subjects cannot be guaranteed; 5) Myocardial infarction or stroke occurred in the last 6 months, and malignant tumor was diagnosed in the last 5 years; 6) Alcohol or drug abuse in the last 1 year; 7) Participated in clinical studies related to weight loss and received experimental drug therapy for weight loss in the past 6 months.

Design outcomes

Primary

MeasureTime frame
Weight;

Secondary

MeasureTime frame
HbA1c;Body composition;C peptide;Insulin;Blood glucose;Glycated albumin;Body mass index;

Countries

China

Contacts

Public ContactXiaoling Cai

Peking University People's Hospital

dr_junel@sina.com+86 130 5139 6340

Outcome results

None listed

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