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
NCT07768813 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2026-08-18
Summary
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.
Conditions
- Healthy
- Obesity
Interventions
- COMBINATION_PRODUCT
-
Survodutide formulation A
Pre-filled pen
- DRUG
-
Survodutide formulation B2
Survodutide formulation B2
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2026-12-08
- Completion
- 2026-12-22
- FDA Drug
- Yes
Countries
- Germany
Study Locations
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