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

NCT ID: NCT07071974

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-28
• Study Completion Date: 2025-10-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BI 456906 formulation A then BI 456906 formulation B2

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

Group Type: EXPERIMENTAL

BI 456906 formulation A

Intervention Type: DRUG

BI 456906 formulation A

BI 456906 formulation B2

Intervention Type: DRUG

BI 456906 formulation B2

BI 456906 formulation B2 then BI 456906 formulation A

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

Group Type: EXPERIMENTAL

BI 456906 formulation A

Intervention Type: DRUG

BI 456906 formulation A

BI 456906 formulation B2

Intervention Type: DRUG

BI 456906 formulation B2

Interventions

BI 456906 formulation A

BI 456906 formulation A

Intervention Type: DRUG

BI 456906 formulation B2

BI 456906 formulation B2

Intervention Type: DRUG

Other Intervention Names

Survodutide; Survodutide

Eligibility Criteria

Inclusion Criteria

Trial participants will only be included in the trial if they meet the following criteria:

1. 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

2. Age of 18 to 55 years (inclusive)

3. Body Mass Index (BMI) of 18.5 to 29.9 kg/m (inclusive)

Exclusion Criteria

Participants will not be allowed to participate, if any of the following general criteria apply:

1. Any finding in the medical examination (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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CRS Clinical Research Services Berlin GmbH

Berlin, , Germany

Countries

Germany

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

2025-521419-37-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1319-7116

Identifier Type: REGISTRY

Identifier Source: secondary_id

1404-0099

Identifier Type: -

Identifier Source: org_study_id