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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 456906 formulation A; Drug: BI 456906 formulation B2

Study type: Interventional

Funder types: Industry

Identifiers

NCT07071974

U1111-1319-7116 (Registry Identifier)

1404-0099

2025-521419-37-00 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)
4. Signed and dated written informed consent in accordance with ICH-GCP (Harmonized Guideline for Good Clinical Practice) and local legislation prior to admission to the trial Further inclusion criteria apply.

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

4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

BI 456906 formulation A then BI 456906 formulation B2

Experimental group

Description:

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

Treatment:

Drug: BI 456906 formulation B2

Drug: BI 456906 formulation A

BI 456906 formulation B2 then BI 456906 formulation A

Experimental group

Description:

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

Treatment:

Drug: BI 456906 formulation B2

Drug: BI 456906 formulation A