DelfaGLP-1 Atlas

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RecruitingPhase 1

A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver

Open-label, Randomised, 4 Parallel-group, Phase I Clinical Trial to Investigate BI 456906 Occupancy of Glucagon Receptors in Liver and Glucagon-like Peptide 1 Receptors in Pancreas in Comparison With Semaglutide After Administration of Radiolabeled Tracer in Male and Female Subjects With Obesity Using PET and MRI

Assets

Semaglutide / Survodutide

Listed sites

1

Recruiting sites

1

Enrollment

30

estimated

Study population

Obesity / overweight

Key I/E criteria

•BMI 30-40•Healthy volunteers

Primary endpoint

•Percentage of glucagon (GCG) receptors occupancy in the liver

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

NCT IDNCT05202353
Org study ID1404-0047
Secondary ID2021-000363-76
Secondary ID2024-515417-17-00

Timeline

Milestones

Study first posted2022-01-21actual
Study start2024-10-01actual
Last update posted2026-05-27actual
Primary completion2026-12-02estimated
Study completion2027-01-01estimated

Assets

Investigational agents

SemaglutideSurvodutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (2)

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)

2 endpoints
Primary/protocol endpoint/low confidence

Percentage of glucagon (GCG) receptors occupancy in the liver using Positron emission tomography (PET) imaging at End of Treatment (EOT) visit

Time frame:up to Week 17

descriptive

Secondary/protocol endpoint/low confidence

Percentage of glucagon-like Peptide 1 (GLP-1) receptors occupancy in the pancreas using PET imaging at EOT visit

Time frame:up to Week 17

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.