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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)

Status: Recruiting
Location: See location...
Intervention Type: Drug, Combination product
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• 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)

• Signed and dated written informed consent in accordance with international council for harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply.

Locations
Other Locations
Germany
Humanpharmakologisches Zentrum Biberach
RECRUITING
Biberach
Contact Information
Primary
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127
Time Frame
Start Date: 2026-03-03
Estimated Completion Date: 2026-06-08
Participants
Target number of participants: 56
Treatments
Experimental: Survodutide formulation A then Survodutide formulation B2
Survodutide formulation A = Reference treatment Survodutide formulation B2 = Test treatment
Experimental: Survodutide formulation B2 then Survodutide formulation A
Survodutide formulation A = Reference treatment Survodutide formulation B2 = Test treatment
Related Therapeutic Areas
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov

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