GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study in People With Overweight or Obesity to Test How Well Different Doses of BI 1820237 Are Tolerated When Given Alone or in Combination With Either Semaglutide or BI 456906

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Different Titration Schedules of Subcutaneous Doses of BI 1820237 Alone or Together With Either Semaglutide or BI 456906 in Otherwise Healthy Male and Female Individuals With Obesity/Overweight (Multiple Dose, Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Lead sponsor

Boehringer Ingelheim

Assets

Semaglutide / Survodutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI 27-40•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 IDNCT05751226

Org study ID1458-0002

Secondary ID2022-002733-34

Timeline

Milestones

Study first posted2023-03-02actual

Study start2023-04-11actual

Primary completion2024-08-01actual

Study completion2024-08-01actual

Last update posted2025-01-22actual

Assets

Investigational agents

Semaglutide Survodutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•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

•Age of 18 to 55 years (inclusive)

•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

•Body weight greater than or equal to 75 kg

•Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

•Further inclusion criteria apply.

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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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, bariatric surgery or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (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 treatment-emergent adverse events

Time frame:Up to 180 days

Treatment-emergent AEs (any)

threshold achievement, event

Secondary/protocol endpoint

Area under the concentration-time curve of BI 1820237 in plasma over the time interval from 0 to 168 hours after administration of BI 1820237 or placebo (AUC0-168)

Time frame:Up to 141 days

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum measured concentration of BI 1820237 in plasma (Cmax)

Time frame:Up to 141 days

Cmax

concentration, 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.