NCT07413913

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
0mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Mar 2026Jun 2026

First Submitted

Initial submission to the registry

February 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

March 3, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2026

Expected
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2026

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

February 10, 2026

Last Update Submit

April 14, 2026

Conditions

HealthyObesity

Outcome Measures

Primary Outcomes (3)

  • 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)

    Up to Day 22

  • Maximum measured concentration of the analyte in plasma (Cmax)

    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-∞)

    Up to Day 22

Study Arms (2)

Survodutide formulation A then Survodutide formulation B2

EXPERIMENTAL

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

Combination Product: Survodutide formulation ACombination Product: Survodutide formulation B2

Survodutide formulation B2 then Survodutide formulation A

EXPERIMENTAL

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

Combination Product: Survodutide formulation ACombination Product: Survodutide formulation B2

Interventions

Survodutide formulation ACOMBINATION_PRODUCT

Pre-filled syringe

Also known as: BI 456906
Survodutide formulation A then Survodutide formulation B2Survodutide formulation B2 then Survodutide formulation A
Survodutide formulation B2COMBINATION_PRODUCT

Pre-filled pen

Also known as: BI 456906
Survodutide formulation A then Survodutide formulation B2Survodutide formulation B2 then Survodutide formulation A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

MeSH Terms

Conditions

Obesity

Interventions

BI 456906

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 17, 2026

Study Start

March 3, 2026

Primary Completion (Estimated)

May 28, 2026

Study Completion (Estimated)

June 8, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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

Locations

DE(1)