None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : This clinical study will be conducted as an open, single-group, multiple-dose, dose-escalation study. All patients will receive the same medication.
The dose wi
0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg.
Wegovy will be administered once a week for a total of four weeks in a dose group. After four weeks, the dose will be increased to the next level of dose g
Sponsors
Gachon University Gil Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 to 65 at the time of screening 2) Overweight patients with a body mass index (BMI) of 30.0 or higher at the time of screening or an initial BMI of 27.0 or higher but less than 30.0 and one or more weight-related comorbidities [e.g., hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease] 3) Those who have received an explanation of the digital devices used in clinical trials and are proficient in using non-face-to-face procedures. 4) Those who are willing to follow clinical trial procedures and investigator instructions 5) After receiving a detailed explanation of this clinical trial and fully understanding it, those who voluntarily decided to participate and gave written consent before the screening test
Exclusion criteria
Exclusion criteria: 1) Subjects with evidence or history of clinically significant hepatic, gastrointestinal (including pancreatitis), renal, neurologic, immunologic, pulmonary, endocrine (including diabetes), hematological, neoplastic, cardiovascular or psychiatric (including mood disorder and obsessive disorder) 2) Subjects with history of hypersensitivities including drug allergies or history of clinically significant hypersensitivities 3) Subjects who meet the following criteria at the time of the screening examination; • Serum AST(SGOT) or ALT(SGPT): > 3 times upper normal limit • HbA1c > 6.5% • eGFR calculated by CKD-EPI (2021): 160 mmHg or DBP > 100 mmHg 4) Subjects with a history of drug abuse or who have tested positive for drugs of abuse in a urine drug screening test 5) Subjects who have taken any prescribed medicines or herbal medicines within 2 weeks before the first administration of the investigational product, any non-prescribed medicines or vitamin supplements within 1 week before the first administration of the investigational product. (If other conditions are satisfied or the 5 times of half-life of administered drug would be passed until Day 1, subjects may be eligible for the trial by the investigator’s judgment.) 6) Subjects who have donated a unit of blood within 2 months or blood components within 1 month or have received blood transfusion within 1 month before the first administration of the investigational product. 7) Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or unable to abstain from drinking throughout the trial. 8) Subjects who did not use the following medically acceptable contraceptive methods during the entire clinical trial period • Use of an intrauterine device (copper loop, hormone-containing intrauterine system) with a proven pregnancy loss rate in the spouse (or partner) • Combination of either spermicide or non-oral hormonal contraceptives with a barrier method of contraception (for men or women) • Surgery on yourself or your partner (vasectomy, salpingectomy/ligation, hysterectomy, etc.) • Using a cervical cap or diaphragm in combination with a male condom 9) Pregnant or breastfeeding women 10) A person who is judged by the investigator to be unsuitable for clinical trial participation for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event monitoring, clinical laboratory test, vital signs;Weigh loss | — |
Secondary
| Measure | Time frame |
|---|---|
| Ctrough, Ctrough/Dose of semaglutide | — |
Countries
Korea, Republic of
Contacts
Public ContactDongseong Shin
Gachon University Gil Medical Center
Outcome results
None listed