Tokyo, Dec. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060122) titled 'Effect of Tirzepatide on body weight and body composition in people with obesity' on Dec. 18.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - ASO Clinic, Director

Condition: Condition - Obesity Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the efficacy and safety of Tirzepatide treatment on body weight and body composition in people with obesity. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - After six months of standard obesity management, including dietary counseling and exercise therapy, subcutaneous administration of tirzepatide (2.5 mg once weekly) will be initiated. While monitoring body weight changes and tolerability, the dose may be escalated as appropriate (to 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg once weekly), with the principle that each dose level is maintained for a minimum of four weeks before further escalation. Following a total treatment period of 72 weeks, the intervention will be discontinued. Subsequently, physical and metabolic changes will be continuously monitored for an additional six months, and up to one year if patient consent is obtained.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - The target sample size across all participating institutions is 40 patients. Eligible participants will be those who meet the inclusion criteria listed below and do not meet any of the exclusion criteria.

Inclusion Criteria Patients diagnosed with one or more of the following conditions-type 2 diabetes mellitus, hypertension, and/or dyslipidemia-and currently receiving pharmacological treatment.

Patients who have received nutritional counseling at least once every two months for a minimum of six months, in accordance with an established treatment plan.

BMI more than 35 kg/m2, or BMI more than 27 kg/m2 with two or more obesity-related health complications (see below). Obesity-Related Health Complications Impaired glucose tolerance (type 2 diabetes mellitus/impaired glucose tolerance) Dyslipidemia Hypertension Hyperuricemia/gout Coronary artery disease Cerebral infarction / transient ischemic attack Non-alcoholic fatty liver disease Menstrual disorders / female infertility Obstructive sleep apnea syndrome / obesity hypoventilation syndrome Musculoskeletal disorders (osteoarthritis / spondylosis) Obesity-related kidney disease Key exclusion criteria - 1. Cases with obvious infection. 2. Cases of obvious chronic inflammatory diseases such as autoimmune diseases, or cases of long-term use of steroid drugs for treatment. 3. Cases diagnosed with advanced cancer. 4. Fresh case of cerebrovascular accident (within 12 weeks of onset). 5. Cases with liver dysfunction (ALT > 3 x facility upper limit). 6. Cases with complications that are judged to seriously impede the conduct of the study, such as respiratory disease, poorly controlled heart failure, or arrhythmia. 7. Cases with a history of alcoholism or drug addiction, or cases with psychosis or psychotic symptoms that make it difficult to participate in the study. 8. In other cases where the doctor in charge of the study determines that the subject is unsuitable for the safe conduct of this study. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 01 Day Anticipated trial start date - 2025 Year 12 Month 15 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068711

Disclaimer: Curated by HT Syndication.