The study is designed as a triple-blinded trial. In this study, participants, principal investigators, healthcare and research personnel responsible for patient care, data collectors, outcome assessors, and members of the Data Safety and Monitoring Board (DSMB) will be blinded to the allocation of participants to the intervention or control groups.
The randomization and allocation process will be performed by an independent individual who is not involved in patient treatment, outcome assessment, or data analysis. Allocation codes will be kept in confidential sealed envelopes and will not be accessible to the research team, participants, or outcome assessors until completion of the final data analysis, except in emergency situations related to patient safety.
Participants in the intervention group will receive tirzepatide, while participants in the control group will receive placebo. The placebo will contain all inactive ingredients and excipients of the active drug formulation except for the active ingredient tirzepatide. Placebo pens will be identical to the active drug pens in appearance, color, volume, odor, packaging, storage conditions, and method of administration. In addition, placebo pens will be prepared in visual dose presentations corresponding to 2.5, 5, 7.5, and 10 milligrams in order to maintain an identical dose-escalation process in both groups and prevent identification of treatment allocation.
Administration of the active drug and placebo in both groups will be performed subcutaneously once weekly, on a fixed day and time, by a trained nurse. All participants in both groups will undergo identical administration procedures, follow-up visits, and outcome assessments in order to maintain blinding throughout all stages of the study.