Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Obesity
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 reg...
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
Key Trial Info
Start Date :
March 3 2026
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT07413913
Start Date
March 3 2026
End Date
June 8 2026
Last Update
April 17 2026
Active Locations (1)
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1
Humanpharmakologisches Zentrum Biberach
Biberach, Germany, 88397