RecruitingNCT07768813Updated Sep 9, 2026

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

A Phase 1 interventional study of Survodutide formulation A and Survodutide formulation B2 in Healthy and Obesity, sponsored by Boehringer Ingelheim. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 44
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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 studied

Healthy
Obesity

Browse trials for

Obesity 6,243

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria:

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
Further exclusion criteria apply.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 44 participants (estimated)

Study arms

Experimental
BI 456906 formulation A (Reference) then BI 456906 formulation B2 (Test)
Subcutaneous administration of formulation A (Reference) then formulation B2 (Test)
Combination Product: Survodutide formulation A · Drug: Survodutide formulation B2
Experimental
BI 456906 formulation B2 (Test) then BI 456906 formulation A (Reference)
Subcutaneous administration of formulation B2 (Test) then formulation A (Reference)
Combination Product: Survodutide formulation A · Drug: Survodutide formulation B2

Interventions

Combination productSurvodutide formulation A
Pre-filled pen
Also known as: BI 456906
DrugSurvodutide formulation B2
Survodutide formulation B2
Also known as: BI 456906

What researchers measure

Primary outcomes

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
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to Day 22
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to Day 22

Study locations

1 of 1 sites recruiting

hVIVO Mannheim
Mannheim, 68167, Germany
- Boehringer Ingelheim · Contact · deutschland@bitrialsupport.com · 08007234742
Recruiting

References and documents

Individual participant data

Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Registry details

Key details

Study ID: NCT07768813
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Aug 17, 2026
Start date: Sep 2, 2026
Primary completion: Dec 8, 2026 (estimated)
Completion: Dec 22, 2026 (estimated)
Last update: Sep 9, 2026

Study contacts

Boehringer Ingelheim

Contact

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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