A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity

Sponsor
Boehringer Ingelheim
Study ID
NCT07768813
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The main objective of this trial is to establish the bioequivalence of survodutide in a pre-filled syringe (reference product \[formulation A\]) and in a vial (test product \[formulation B2\]) in male and female trial participants who are healthy or otherwise healthy with overweight/obesity, following subcutaneous administration.

Key Dates

First listed
Aug 17, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Dec 8, 2026
Completion
Dec 22, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: BI 456906 formulation A (Reference) then BI 456906 formulation B2 (Test)
    Subcutaneous administration of formulation A (Reference) then formulation B2 (Test)
  • Experimental: BI 456906 formulation B2 (Test) then BI 456906 formulation A (Reference)
    Subcutaneous administration of formulation B2 (Test) then formulation A (Reference)

Primary Outcome Measure

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [ Time Frame: Up to Day 22 ]

Central Contacts

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