A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body

Launched by BOEHRINGER INGELHEIM · Jul 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different versions of a medicine called Survodutide to see how each one is absorbed and used by the body. The goal is to compare the “reference” version (Formulation A) with a “test” version (Formulation B2) in healthy adults. This is an early-phase study, meaning it is mainly focused on understanding how the medicine behaves in the body rather than treating any illness.

To take part, you need to be a healthy man or woman between the ages of 18 and 55, with a body weight that falls within a certain range (measured by BMI). Participants will go through a health check that includes a physical exam, blood pressure and heart rate measurements, an ECG (which records the heart’s activity), and blood tests to make sure their organs are working well. If you qualify, you will be closely monitored throughout the study to see how your body processes each version of the medicine. The trial has not started recruiting yet, and if you have any health issues or abnormal test results, you may not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria :
• Trial participants will only be included in the trial if they meet the following criteria:
• • 1. 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
• • 2. Age of 18 to 55 years (inclusive)
• • 3. Body Mass Index (BMI) of 18.5 to 29.9 kg/m (inclusive)
• • 4. Signed and dated written informed consent in accordance with ICH-GCP (Harmonized Guideline for Good Clinical Practice) and local legislation prior to admission to the trial Further inclusion criteria apply.
• Exclusion Criteria :
• Participants will not be allowed to participate, if any of the following general criteria apply:
• • 1. Any finding in the medical examination (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 and, in particular:
• • Alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20%
• • Aspartate aminotransferase (AST) above Upper limit of normal (ULN) + 20%
• • Gamma Glutamil Transferase (GGT) above Upper limit of normal (ULN) + 20%
• • Lipase or amylase above Upper limit of normal (ULN) + 20%
• • Bilirubin above 1.2x Upper limit of normal (ULN) (except for cases of Gilbert's Syndrome)
• • Estimated Glomerular Filtration Rate Estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1.73 m²
• • 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.