Status:
RECRUITING
A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is open to healthy people between 18 and 65 years of age. People can join the study if they have a body mass index between 27 and 39.9 kg/m2. The purpose of this study is to test a new for...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy male or female trial participant 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 65 years (inclusive)
- Body mass index (BMI) of 27.0 to 39.9 kg/m² (inclusive)
- Signed and dated written informed consent in accordance with 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 blood pressure outside the range of 90 to 150 mmHg, diastolic blood pressure outside the range of 50 to 100 mmHg, or pulse rate outside the range of 50 to 100 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. Presence of hypertension, hypothyroidism, hyperuricaemia and hypercholesterolaemia are acceptable if well-controlled according to the investigator's judgement.
- Further exclusion criteria apply.
Exclusion
Key Trial Info
Start Date :
November 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 24 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07221591
Start Date
November 5 2025
End Date
August 24 2026
Last Update
December 24 2025
Active Locations (2)
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1
CRS Clinical Research Services Berlin GmbH
Berlin, Germany, 13627
2
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany, 68167