COMBINATION_PRODUCT
survodutide
survodutide, pre-filled syringe
Status
Active, not recruiting
Phase
Phase 1
Enrollment
100
Locations
2
Results
Not posted
Publications
0
Study 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 formulation of a medicine called survodutide. Survodutide is being developed to help people with obesity and people with liver conditions. When a new formulation is developed, it is important to understand how it is taken up by the body. Participants are divided into 2 groups by chance. One group gets the reference formulation of survodutide (formulation A). The other group gets the new formulation of survodutide (formulation B2). Participants in both groups inject survodutide under their skin once a week for about 6 and a half months. Participants are in the study for about 7 months. During this time, they visit the study site 15 times. For one of the visits, participants stay overnight for 3 nights at the study site. The site staff takes blood samples to measure how much survodutide is in the blood. They also check participants' health and take note of any unwanted effects.
Interventions
COMBINATION_PRODUCT
survodutide, pre-filled syringe
Timeline
First posted
Oct 28, 2025
Study start
Nov 5, 2025
Primary completion
Aug 4, 2026
Study completion
Aug 4, 2026
Results posted
Not reported
Registry updated
Mar 13, 2026
Outcomes
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Time frame · up to 232 days
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Time frame · up to 232 days
Not reported in the indexed record.
Eligibility
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.
Study locations
Germany. Showing up to 24 locations stored in the fast local snapshot.
CRS Clinical Research Services Berlin GmbH
Berlin, Germany
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany
Publications
No PMID-linked publications were present in this registry snapshot.
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