RecruitingPhase 1NCT07413913

A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways, Either as a Pre-filled Syringe or a Pen-like Injector

Bioequivalence of Survodutide (BI 456906) When Administered Via Pre-filled Syringe (Formulation A) and Pre Filled Pen (Formulation B2) in Male and Female Trial Participants Who Are Healthy or Otherwise Healthy With Overweight/Obesity (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Trial)

Sponsor

Boehringer Ingelheim

Enrollment

56 participants

Start Date

Mar 3, 2026

Study Type

INTERVENTIONAL

Conditions

Obesity Healthy

Summary

The goal of this study is to find out whether different formulations of survodutide given by different delivery methods is taken up in the body in a similar way. Participants visit the study site regularly. During study visits, the doctors collect information about participants' health. To assess the study endpoints, participants regularly have blood samples taken.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria3

Male or female trial participant who is healthy or otherwise healthy with overweight/obesity according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (inclusive)
Body mass index (BMI) of 22.0 to 39.9 kg/m2 (inclusive)

Exclusion Criteria3

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 45 to 90 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

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