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CompletedNCT07413913Updated Jun 15, 2026

A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways, Either as a Pre-filled Syringe or a Pen-like Injector

A Phase 1 interventional study of Survodutide formulation A and Survodutide formulation B2 in Healthy and Obesity, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-15.

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

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study summary

The goal of this study is to find out whether different formulations of survodutide given by different delivery methods is taken up in the body in a similar way.

Participants visit the study site regularly. During study visits, the doctors collect information about participants' health. To assess the study endpoints, participants regularly have blood samples taken.

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Conditions studied

  • Healthy
  • Obesity

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03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 56 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

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

Inclusion criteria

  1. 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
  2. Age of 18 to 55 years (inclusive)
  3. Body mass index (BMI) of 22.0 to 39.9 kg/m2 (inclusive)
  4. 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:

  1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
  2. Repeated measurement of systolic BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 45 to 90 beats per minute (bpm)
  3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Survodutide formulation A then Survodutide formulation B2

    Survodutide formulation A = Reference treatment Survodutide formulation B2 = Test treatment

    Combination Product: Survodutide formulation A · Combination Product: Survodutide formulation B2

  • Experimental
    Survodutide formulation B2 then Survodutide formulation A

    Survodutide formulation A = Reference treatment Survodutide formulation B2 = Test treatment

    Combination Product: Survodutide formulation A · Combination Product: Survodutide formulation B2

Interventions

  • Combination productSurvodutide formulation A

    Pre-filled syringe

    Also known as: BI 456906

  • Combination productSurvodutide formulation B2

    Pre-filled pen

    Also known as: BI 456906

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What researchers measure

Primary outcomes

  1. 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

  2. Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: Up to Day 22

  3. 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

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Study locations

1 site
  • Humanpharmakologisches Zentrum Biberach
    Biberach, 88397, Germany
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References and documents

Related links

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

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07413913
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Feb 17, 2026
Start date
Mar 3, 2026
Primary completion
May 28, 2026
Completion
Jun 11, 2026
Last update
Jun 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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