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

Sponsor
Boehringer Ingelheim
Study ID
NCT07221591
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • survodutide — COMBINATION_PRODUCT
    survodutide, pre-filled syringe

Study Details

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.

Key Dates

Start date
Nov 5, 2025
Status verified
Mar 2026
Primary completion
Aug 4, 2026
Completion
Aug 4, 2026

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: survodutide formulation A (reference treatment)
  • Experimental: survodutide formulation B2 (test treatment)

Primary Outcome Measure

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 ]

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