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ACTIVE NOT RECRUITING
NCT07221591
PHASE1

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official 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)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-11-05

Completion Date

2026-08-04

Last Updated

2026-03-13

Healthy Volunteers

Yes

Conditions

Interventions

COMBINATION_PRODUCT

survodutide

survodutide, pre-filled syringe

Locations (2)

CRS Clinical Research Services Berlin GmbH

Berlin, Germany

CRS Clinical Research Services Mannheim GmbH

Mannheim, Germany