Tokyo, June 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061914) titled 'Switching from semaglutide to tirzepatide in obesity management: effects on body weight and metabolic parameters' on June 15.

Study Type: Interventional

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

Primary Sponsor: Institute - Aso clinic

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

Objective: Narrative objectives1 - The aim of the study is to evaluate the effects of switching to tirzepatide on body weight, body composition, and metabolic parameters, as well as its safety, in patients who previously underwent obesity treatment with semaglutide and require retreatment. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Patients who require retreatment after completing semaglutide therapy and express a preference to switch to tirzepatide treatment will receive tirzepatide.

Eligibility: Age-lower limit - 20 years-old =35, or a BMI of >=27 with two or more obesity-related health disorders.*

*Obesity-related health disorders: 1) Glucose intolerance, including type 2 diabetes mellitus or impaired glucose tolerance; 2) dyslipidemia; 3) hypertension; 4) hyperuricemia/gout; 5) coronary artery disease; 6) cerebral infarction/transient ischemic attack; 7) non-alcoholic fatty liver disease; 8) menstrual disorders/female infertility; 9) obstructive sleep apnea syndrome/obesity hypoventilation syndrome; 10) musculoskeletal disorders, including osteoarthritis and spondylosis deformans; and 11) 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 - Open public recruiting Date of protocol fixation - 2026 Year 03 Month 05 Day Date of IRB - 2026 Year 03 Month 04 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070830

Disclaimer: Curated by HT Syndication.