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

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: survodutide

• Registration Number: NCT07221591
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-27
• Study First Submitted QC: 2025-10-27
• Last Update Submitted: 2025-10-27
• Study First Posted: 2025-10-28
• Last Update Posted: 2025-10-28
• Study Start: 2025-11-05
• Primary Completion: 2026-08-24
• Study Completion: 2026-08-24

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
survodutide formulation A (reference treatment)	survodutide	-
survodutide formulation B2 (test treatment)	survodutide	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)	up to 232 days
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)	up to 232 days

Trial Locations

Locations (2)

CRS Clinical Research Services Berlin GmbH; 🇩🇪 Berlin, Germany

CRS Clinical Research Services Mannheim GmbH; 🇩🇪 Mannheim, Germany