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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services Berlin GmbH, Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Survodutide

Combination Product

survodutide, pre-filled syringe

Primary 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Relative Bioavailability of Two Survodutide (BI 456906) Formulations When Administered Subcutaneously Via Pre-filled Syringe Over 28 Weeks (an Open-label, Randomised, Multiple Dose, Parallel Group Trial)

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Oct 28, 2025
Registry last updated: Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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