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A Study in People With Overweight or Obesity to Test How BI 1820237, BI 456906, or a Combination of Both Affects Brain Activity
A Single-dose, Randomized, Placebo-controlled Phase I Study on the Effects of a Subcutaneous Dose of BI 1820237 and BI 456906, and Combination Thereof on Functional MRI Measurements in Otherwise Healthy Male and Female Individuals With Obesity/Overweight (Single-blind, Cross-over Design)
Lead sponsor
Asset
Survodutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
1
Recruiting sites
—
Enrollment
23
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI 27-40
Primary endpoint
•Blood Oxygen Level Dependent (BOLD) signal changes following treatment
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Male or female subjects with obesity/overweight (otherwise healthy) 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 40 to 60 years (inclusive)
3. Body mass index (BMI) of 27.0 to 40.0 kg/m2 (inclusive). Overweight/obesity should be due to excess adipose tissue, as judged by the Investigator
4. Body weight greater than or equal to 75 kg
5. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
6. Male trial participants without need for contraception
7. Female trial participants, only if any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 2 months after last administration of trial medication are met:
Or female subject meets any of the following criteria:
Exclusion criteria
1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm and assessed as clinically relevant by the investigator
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Endpoints (1)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Other (unclassified)
1 endpointBlood Oxygen Level Dependent (BOLD) signal changes following treatment with single dose of BI 1820237 alone, BI 456906 alone, and combination of BI 1820237 + BI 456906 versus placebo
Time frame:32 days plus up to 8 weeks wash-out for each sequence, up to 51 weeks
change from baseline, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.