DelfaGLP-1 Atlas

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CompletedPhase 1

A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems

Pharmacokinetics, Safety, and Tolerability of BI 456906 Following Subcutaneous Injection in Male and Female Participants With Mild, Moderate and Severe Renal Impairment in Comparison to Participants With Normal Renal Function (Mono-centric, Open-label Study With Parallel Matched-pair Design)

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

2

Recruiting sites

—

Enrollment

42

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criteria

•BMI 20-40•eGFR 10-29

Primary endpoints

•AUC of BI 456906 in plasma over the time interval from 0 to the last•Maximum measured concentration of BI 456906 in plasma (Cmax)

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 IDNCT06352411
Org study ID1404-0009
Secondary ID2023-508557-13-00CTIS
Secondary IDU1111-1298-3135WHO registry

Timeline

Milestones

Study first posted2024-04-08actual
Study start2024-05-15actual
Primary completion2025-09-16actual
Study completion2025-09-16actual
Last update posted2026-03-13actual

Assets

Investigational agents

Survodutide

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

applicable to all participants

Participants will only be included in the trial if they meet the following criteria:

•Male or female participants with age 18 to 80 years, inclusive at the screening visit.
•Body mass index (BMI) of 20.0-40.0 kg/m^2 (inclusive).
•Signed and dated written informed consent in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use -good clinical practice (ICH-GCP) and local legislation prior to admission to the trial.
•Male participants are not required to use contraception. Further criteria apply.

Inclusion criteria applying only to participants with impaired renal function:

•Renal impairment based on assessment of estimated glomerular filtration rate (eGFR) at screening (severe renal impairment: 10.0-29.9 mL/min, moderate renal impairment: 30.0 - 59.9 mL/min (with at least 4 participants with a GFR between 30.0 and 45.0 mL/min), mild renal impairment: 60.0 - 89.9 mL/min)
•Chronic renal impairment > 12 months (documented renal impairment indicated by reduced eGFR for more than 12 months until screening)
•Absence of clinically significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening, with the exception of findings that in the opinion of the investigator are consistent with the participant's renal impairment.
•Medication and/or treatment regimens must have been stable (i.e., no dose adjustments) for at least 4 weeks prior to the screening period and should be kept stable until study completion. Fluctuating treatment regimens may be considered for inclusion on a case-by-case basis if the underlying disease is under control in the opinion of the investigator and must be agreed to by both the investigator and the sponsor's medical monitor. Further criteria apply.

Exclusion criteria

applying to all participants

•Any evidence of a concomitant disease assessed as clinically relevant by the investigator
•Diseases of the central nervous system (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders (including but not limited to major depressive disorder)
•History of relevant orthostatic hypotension, fainting spells, or blackouts
•Relevant chronic or acute infections Further criteria apply.

Exclusion criteria applying only to participants with renal impairment

•A marked prolongation of ECG interval from the start of the QRS complex (measured from the beginning of the Q wave to the end of the S wave) to the end of the T wave (QT)/QT interval corrected for heart rate, e.g. using the method of Fridericia (QTcF) or Bazett (QTcB)(QTc) interval (such as QTc intervals that are repeatedly greater than 480 milliseconds (ms) in males or repeatedly greater than 500 ms in females) or any other relevant ECG finding at screening
•Acute renal failure or active nephritis
•Nephrotic syndrome
•Impaired hepatic function, including relevant increases in liver enzymes indicating liver disease Further criteria apply.

Endpoints (4)

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

4 endpoints
Primary/protocol endpoint

Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

Time frame:up to Day 29

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Maximum measured concentration of BI 456906 in plasma (Cmax)

Time frame:up to Day 29

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

Time frame:up to Day 29

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

Time frame:up to 36 days

Treatment-emergent AEs (any)

event count, event

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.