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
- Sponsor
- Boehringer Ingelheim
- Study ID
- NCT07413913
- Phase
- PHASE1
- Status
- Active Not Recruiting
Conditions
- Healthy
- Obesity
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- Survodutide formulation A — COMBINATION_PRODUCTPre-filled syringe
- Survodutide formulation B2 — COMBINATION_PRODUCTPre-filled pen
Study Details
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.
Key Dates
- Start date
- Mar 3, 2026
- Status verified
- May 2026
- Primary completion
- May 28, 2026
- Completion
- Jun 8, 2026
Study Design
- Enrollment
- 56 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Survodutide formulation A then Survodutide formulation B2Survodutide formulation A = Reference treatment Survodutide formulation B2 = Test treatment
- Experimental: Survodutide formulation B2 then Survodutide formulation ASurvodutide formulation A = Reference treatment Survodutide formulation B2 = Test treatment
Primary Outcome Measure
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [ Time Frame: Up to Day 22 ]
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