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NOT YET RECRUITING
NCT07768813
PHASE1

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

View on ClinicalTrials.gov

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.

Official title: Bioequivalence of Survodutide (BI 456906) When Administered Via Pre-filled Syringe (Formulation A) and Vial (Formulation B2) in Male and Female Trial Participants Who Are Healthy or Otherwise Healthy But Overweight/Obese (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Trial)

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2026-09-01

Completion Date

2026-12-22

Last Updated

2026-08-18

Healthy Volunteers

Yes

Conditions

Interventions

COMBINATION_PRODUCT

Survodutide formulation A

Pre-filled pen

DRUG

Survodutide formulation B2

Survodutide formulation B2

Locations (1)

hVIVO Mannheim

Mannheim, Germany