A Single-center, Randomized, Open-label, Parallel-group, Controlled, Exploratory Study to Evaluate the Efficacy and Safety of a Lifestyle Modification Application (DEX-1-OB) as an Add-on to GLP-1/GIP Receptor Agonist Therapy in Adults with Obesity

Kangbuk Samsung Medical Center0 个研究点目标入组 40 人开始时间: 2026年6月8日最近更新: 2026年7月20日

适应症

试验速览

暂无简介。

•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).
•Naïve to tirzepatide, or with the last administration occurring at least 3 months prior to Visit
•Willing to comply with recommended hypocaloric diet and exercise throughout the study.
•Able to use a smartphone and the mobile application required for the study.
•Provided written informed consent after fully understanding the study procedures.

•Hypersensitivity to tirzepatide or any of its components.
•Secondary causes of obesity or musculoskeletal disorders that limit the ability to perform exercise.
•Clinically significant systemic diseases (e.g., cardiovascular, hepatic, renal, endocrine, neurological, or psychiatric) that may compromise safety or study outcomes.
•Use of anti-obesity medications or weight-altering treatments within 3 months prior to Visit
•Diabetes mellitus, defined as fasting plasma glucose =126 mg/dL or current use of antidiabetic medications.
•History of acute or chronic pancreatitis, or personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
•History of bariatric surgery or planned bariatric procedures during the study.
•Uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg).
•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
•Participation in another investigational drug trial within 4 weeks prior to Visit
•Failure to use appropriate contraception when the partner is of childbearing potential.
•Any other condition that, in the investigator’s judgment, makes the participant unsuitable for the study.

发起方