None listed
Conditions
Interventions
Drug, Behavioral, Others(life modification application) : 1. Lifestyle Intervention Application
Name:
DEX-1-OB smartphone application
Frequency and Duration of Use:
Participants will be encouraged to
Sponsors
Kangbuk Samsung Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Adults aged =19 years who meet the criteria for obesity: -BMI = 30 kg/m², or - BMI 27 to <30 kg/m² with at least one obesity-related comorbidity (e.g., hypertension, dyslipidemia, prediabetes, obstructive sleep apnea, or cardiovascular disease). 2)Naïve to tirzepatide, or with the last administration occurring at least 3 months prior to Visit 1. 3)Willing to comply with recommended hypocaloric diet and exercise throughout the study. 4)Able to use a smartphone and the mobile application required for the study. 5)Provided written informed consent after fully understanding the study procedures.
Exclusion criteria
Exclusion criteria: 1)Hypersensitivity to tirzepatide or any of its components. 2)Secondary causes of obesity or musculoskeletal disorders that limit the ability to perform exercise. 3)Clinically significant systemic diseases (e.g., cardiovascular, hepatic, renal, endocrine, neurological, or psychiatric) that may compromise safety or study outcomes. 4)Use of anti-obesity medications or weight-altering treatments within 3 months prior to Visit 1. 5)Diabetes mellitus, defined as fasting plasma glucose =126 mg/dL or current use of antidiabetic medications. 6)History of acute or chronic pancreatitis, or personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2). 7)History of bariatric surgery or planned bariatric procedures during the study. 8)Uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg). 9)Clinically significant laboratory abnormalities, including: -TSH =0.1 µIU/mL or =10 µIU/mL -Creatinine =2× the upper limit of normal (ULN) -AST or ALT =3× ULN 10)Participation in another investigational drug trial within 4 weeks prior to Visit 1. 11)Failure to use appropriate contraception when the partner is of childbearing potential. 12)Any other condition that, in the investigator’s judgment, makes the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The baseline-adjusted between-group difference in the least squares (LS) mean percent change in body weight from baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 12 in anthropometric measurements, including: Body mass index (BMI) Waist circumference;Change from baseline to Week 12 in body composition parameters, including: Fat mass Lean mass Percent body fat;Change from baseline to Week 12 in glycemic parameters, including: Fasting plasma glucose (FPG) Glycated hemoglobin (HbA1c) Fasting insulin Homeostatic Model Assessment of Insulin Resistance (HOMA-IR);Percent change from baseline to Week 12 in lipid parameters, including: Total cholesterol Low-density lipoprotein cholesterol (LDL-C) High-density lipoprotein cholesterol (HDL-C) Triglycerides;Change from baseline to Week 12 in blood pressure, including: Sitting systolic blood pressure (sitSBP) Sitting diastolic blood pressure (sitDBP) | — |
Countries
Korea, Republic of
Contacts
Public ContactKyoung-nam Kim
Kangbuk Samsung Medical Center
Outcome results
None listed