A Comparative Study of Pre-filled Syringe versus Pen Injector Formulations of Survodutide in Healthy Volunteers and Individuals with Overweight or Obesity

The primary objective of this study is to compare the pharmacokinetics of two different formulations of survodutide, administered via a pre-filled syringe or a pen-like injector, in healthy volunteers or individuals with overweight or obesity. This comparison is clinically relevant for determining the equivalence of delivery devices in ensuring consistent drug absorption and systemic exposure. No secondary objectives were identified.

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. The participants fall within a specific age range categorized by code 3. No further details regarding lifestyle considerations or selection processes were provided.

This Phase 3 clinical trial is designed as a comparative study to evaluate two different formulations of survodutide. The research involves participants who are healthy volunteers or individuals classified as having overweight or obesity. The study utilizes different administration methods, specifically a pre-filled syringe and a pen-like injector. The methodology involves a screening visit to assess eligibility, followed by scheduled study visits and an end-of-study visit. The total duration of the trial is estimated to occur between March 2026 and June 2026. Participation may be terminated early if specific clinical conditions are met.

The efficacy assessment for this Phase 3 clinical trial involving healthy volunteers is not specified in the provided documentation.