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

ConditionsHealthyObesity
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBoehringer Ingelheim

About this trial

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.

Eligibility criteria

Qualifiers

Male or female trial participant who is healthy or otherwise healthy with overweight/obesity according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests

Age of 18 to 55 years (inclusive)

Body mass index (BMI) of 22.0 to 39.9 kg/m² (inclusive)

Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial

Disqualifiers

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator

Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 45 to 90 bpm

Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

Any evidence of a concomitant disease assessed as clinically relevant by the investigator

Trial design

Treatments tested in this trial

  • Survodutide formulation A
  • Survodutide formulation B2

Treatment groups

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators