New obesity drug's brain-body connection revealed in imaging study
NCT ID NCT05202353
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 9 times
Summary
This early-stage study looks at how the experimental drug BI 456906 attaches to receptors in the liver and pancreas that control appetite and weight. About 30 adults with obesity will receive either BI 456906 or the approved weight-loss drug semaglutide for 17 weeks. Researchers use PET and MRI scans to measure receptor occupancy, aiming to understand how the drug works in the body.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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29 people
The number who actually took part.
- Started
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Nov 2024
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 65 years (inclusive) * Body mass index (BMI) of ≥ 30 and ≤ 40 kg/m2 and body weight ≥70 kg and ≤150 kg * Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation * Women of childbearing potential (WOCBP) must be willing and able to use two forms of effective contraception where at least one form is a highly effective method of birth control per International Council for Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly Exclusion Criteria: * Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator * Resting heart rate \> 100 beats per minute (bpm) and/or systolic blood pressure ≥ 160 millimetre of mercury (mmHg) and/or diastolic blood pressure ≥95 mmHg at screening. * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. Subjects with the following abnormal values are not eligible for the trial participation: * Low-density lipoprotein (LDL) \> 160 mg/dL (4.15 mmol/L) * total cholesterol \>240 mg/dL (6.22 mmol/L) * triglyceride \>200 mg/dL (2.26 mmol/L) * blood glucose \> 126 mg/dl (\>7 mmol/L) fasting and/or glycated haemoglobin (HbA1c) \>6.5% (\>48 mmol/mol) * Any evidence of a concomitant disease assessed as clinically relevant by the investigator. Subjects with type 1 and type 2 diabetes mellitus are not eligible for the trial * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator * Diseases of the central nervous system (including but not limited to any kind of seizures), and other relevant neurological or psychiatric disorders * History of relevant orthostatic hypotension, fainting spells, or blackouts * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at Visit 1 Further criteria apply
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Amsterdam UMC, location VUMC
Amsterdam, 1105 AZ, Netherlands
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