NCT07768813Active, not recruitingPhase 1
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
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)
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 12 Aug 2026
- Start date
- 2 Sept 2026
- Primary completion date
- 8 Dec 2026
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Obesity
- NCT number
- NCT07768813
- EU CT number
- 2026-526307-30-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 44
- From 2 Sept 2026 to the primary completion date, 8 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Lab values
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Other
- 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
- Further exclusion criteria apply.
Who the study is looking for
- 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/m\^2 (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
- Further inclusion criteria apply.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| hVIVO Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.