COMBINATION_PRODUCT
Survodutide formulation A
Pre-filled syringe
Status
Completed
Phase
Phase 1
Enrollment
56
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
COMBINATION_PRODUCT
Pre-filled syringe
COMBINATION_PRODUCT
Pre-filled pen
Timeline
First posted
Feb 17, 2026
Study start
Mar 3, 2026
Primary completion
May 28, 2026
Study completion
Jun 11, 2026
Results posted
Not reported
Registry updated
Jun 15, 2026
Outcomes
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
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame · Up to Day 22
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame · Up to Day 22
Not reported in the indexed record.
Eligibility
Inclusion Criteria: 1. 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 2. Age of 18 to 55 years (inclusive) 3. Body mass index (BMI) of 22.0 to 39.9 kg/m2 (inclusive) 4. 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: 1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator 2. 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) 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
Study locations
Germany. Showing up to 24 locations stored in the fast local snapshot.
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
Publications
No PMID-linked publications were present in this registry snapshot.
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