A Comparative Study of Pre-filled Syringe and Pen-injector Formulations of Survodutide in Healthy and Overweight or Obese Volunteers

The primary objective of this study is to compare the bioequivalence of two different formulations of survodutide administered via pre-filled syringe and a pen-like injector in healthy volunteers or individuals who are overweight or obese. Evaluating these delivery methods is clinically relevant to ensure consistent pharmacokinetics and therapeutic performance across different administration devices.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers of both male and female genders. Participants belong to the age range categorized as 3.

This Phase 3 clinical trial is designed to compare two different formulations of survodutide administered via a pre-filled syringe and a pen-like injector. The study will involve healthy volunteers or individuals who are otherwise healthy but classified as overweight or obese. The research methodology utilizes a comparative design to evaluate these delivery methods. The sequence of study visits begins with a screening visit to determine eligibility. Subsequent follow-up visits and an end-of-study visit are scheduled to monitor outcomes. The total duration of participant involvement is determined by the study protocol, although early termination may occur according to predefined clinical criteria.

The assessment of efficacy in this Phase 3 clinical trial involving healthy volunteers is not specified.