DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT04903509

CompletedPhase 1

A Study in Men With Overweight to Test How Well Different Doses of BI 1820237 Are Tolerated When Given as an Injection Alone or in Combination With Liraglutide

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 1820237 Alone (Trial Parts 1+2) or Together With a Low Dose of Liraglutide (Trial Part 3) in Otherwise Healthy Male Subjects With Overweight/Obesity (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

95

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 25-34.9•Male•Healthy volunteers

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT04903509
Org study ID1458-0001
Secondary ID2021-000327-13

Timeline

Milestones

Study first posted2021-05-26actual
Study start2021-06-08actual
Primary completion2022-08-26actual
Study completion2022-08-26actual
Last update posted2022-08-31actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age50 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

•Male subjects with overweight/obesity (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
•Age of 18 to 50 years (inclusive)
•Body mass index (BMI) of 25.0 to 34.9 kg/m2 (inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator
•Body weight greater than or equal to 70 kg
•Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria

•Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
•Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
•Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
•Any evidence of a concomitant disease assessed as clinically relevant by the investigator
•Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
•Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medications except appendectomy or simple hernia repair
•Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
•History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply

Endpoints (3)

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.

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Percentage of subjects with drug-related adverse events

Time frame:up to 48 days

Treatment-emergent AEs (any)

threshold achievement, event

Secondary/protocol endpoint

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

Time frame:up to 38 days

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum measured concentration of the analyte in plasma (Cmax)

Time frame:up to 38 days

Cmax

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.