A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body

NCT07071974 | Completed Phase 1

• 3 other identifiers: 1404-00992025-521419-37-00U1111-1319-7116
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to investigate relative bioavailability of BI 456906 reference formulation (Formulation A) vs. BI 456906 test formulation (Formulation B2).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

  Up to 22 days.

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

  Up to 22 days.

Secondary Outcomes (1)

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

  Up to 22 days.

Study Arms (2)

BI 456906 formulation A then BI 456906 formulation B2

EXPERIMENTAL

BI 456906 formulation A = Reference treatment BI 456906 formulation B2 = Test treatment

Combination Product: BI 456906 formulation A; Drug: BI 456906 formulation B2

BI 456906 formulation B2 then BI 456906 formulation A

EXPERIMENTAL

BI 456906 formulation A = Reference treatment BI 456906 formulation B2 = Test treatment

Combination Product: BI 456906 formulation A; Drug: BI 456906 formulation B2

Interventions

BI 456906 formulation A COMBINATION_PRODUCT

BI 456906 formulation A

Also known as: Survodutide

BI 456906 formulation A then BI 456906 formulation B2; BI 456906 formulation B2 then BI 456906 formulation A

BI 456906 formulation B2 DRUG

BI 456906 formulation B2

Also known as: Survodutide

BI 456906 formulation A then BI 456906 formulation B2; BI 456906 formulation B2 then BI 456906 formulation A

Eligibility Criteria

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

You may qualify if:

• Trial participants will only be included in the trial if they meet the following criteria:
• Healthy male or female trial participant 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 18.5 to 29.9 kg/m (inclusive)

You may not qualify if:

• Participants will not be allowed to participate, if any of the following general criteria apply:
• Any finding in the medical examination (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 and, in particular:
• Alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20%
• Aspartate aminotransferase (AST) above Upper limit of normal (ULN) + 20%
• Gamma Glutamil Transferase (GGT) above Upper limit of normal (ULN) + 20%
• Lipase or amylase above Upper limit of normal (ULN) + 20%
• Bilirubin above 1.2x Upper limit of normal (ULN) (except for cases of Gilbert's Syndrome)
• Estimated Glomerular Filtration Rate Estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1.73 m²

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, 13627, 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: July 16, 2025
• First Posted: July 18, 2025
• Study Start: July 28, 2025
• Primary Completion: October 7, 2025
• Study Completion: October 28, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)