DelfaGLP-1 Atlas

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CompletedPhase 1

A Study to Test Different Doses of BI 456906 in Patients With Obesity

A Phase I, Blinded Within Dose Groups, Multiple Dose, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Different Titration Schemes of BI 456906 in Patients With Obesity and Overweight.

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

2

Recruiting sites

—

Enrollment

131

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI 27-40•HbA1c ≤6.5%

Primary endpoint

•Discontinuation due to AE

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 IDNCT03591718
Org study ID1404-0003
Secondary ID2018-000250-22

Timeline

Milestones

Study first posted2018-07-19actual
Study start2018-07-26actual
Primary completion2020-04-20actual
Study completion2020-04-30actual
Last update posted2021-03-22actual

Assets

Investigational agents

Survodutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male and female patients ≥ 18 years and < 70 years of age at screening
•Body Mass Index (BMI) ≥ 27 kg/m2 and <40 kg/m2 at screening
•A minimum absolute body weight of 70 kg at screening and a stable body weight (defined as no more than 5% change) 3 months prior to screening
•HbA1c <6.5%
•Further inclusion criteria apply

Exclusion criteria

•Women who are pregnant, nursing, or who plan to become pregnant while in the trial
•Supine blood pressure (BP) ≥160/100 mmHg at screening
•Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening
•Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
•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

Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme

Time frame:Up to 132 days

Discontinuation due to AE

event count, event

Secondary/protocol endpoint

AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)

Time frame:Up to 168 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax (maximum measured concentration of the analyte in plasma) after first dose

Time frame:Up to 132 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.