A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the Body

NCT06772532 | Completed Phase 1 FDA Drug

• 3 other identifiers: 1404-00742024-516529-30-00U1111-1310-7283
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to investigate relative bioavailability of BI 456906 formulation B and BI 456906 formulation C vs. BI 456906 formulation A.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 22 days

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

  Up to 22 days

Secondary Outcomes (1)

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  Up to 22 days

Study Arms (3)

Treatment sequence R-T2-T1

EXPERIMENTAL

T1: BI 456906 formulation B T2: BI 456906 formulation C R: BI 456906 formulation A

Combination Product: BI 456906 - Formulation A; Drug: BI 456906 - Formulation B; Drug: BI 456906 - Formulation C

Treatment sequence T1-R-T2

EXPERIMENTAL

Combination Product: BI 456906 - Formulation A; Drug: BI 456906 - Formulation B; Drug: BI 456906 - Formulation C

Treatment sequence T2-T1-R

EXPERIMENTAL

Combination Product: BI 456906 - Formulation A; Drug: BI 456906 - Formulation B; Drug: BI 456906 - Formulation C

Interventions

BI 456906 - Formulation A COMBINATION_PRODUCT

Formulation A

Also known as: Survodutide

Treatment sequence R-T2-T1; Treatment sequence T1-R-T2; Treatment sequence T2-T1-R

BI 456906 - Formulation B DRUG

Formulation B

Also known as: Survodutide

Treatment sequence R-T2-T1; Treatment sequence T1-R-T2; Treatment sequence T2-T1-R

BI 456906 - Formulation C DRUG

Formulation C

Also known as: Survodutide

Treatment sequence R-T2-T1; Treatment sequence T1-R-T2; Treatment sequence T2-T1-R

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects 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 20 to 29.9 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.

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 blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate 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.
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach/Riß, 88397, Germany

Location

Related Links

• Related Info

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: January 10, 2025
• First Posted: January 13, 2025
• Study Start: February 10, 2025
• Primary Completion: May 29, 2025
• Study Completion: June 10, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)