Active — Not RecruitingPhase 1

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

Germany56 participantsStarted 2026-03-03

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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)

Timeframe: Up to Day 22

Maximum measured concentration of the analyte in plasma (Cmax)

Timeframe: 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-∞)

Timeframe: Up to Day 22

Trial details

NCT IDNCT07413913

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-28

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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)

Timeframe: Up to Day 22

Maximum measured concentration of the analyte in plasma (Cmax)

Timeframe: 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-∞)

Timeframe: Up to Day 22