DelfaGLP-1 Atlas

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CompletedPhase 1

A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906

A Non-randomised, Open-label, 2-part, Parallel-cohort Trial to Evaluate 1) Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of BI 456906 in Patients With Cirrhosis and Varying Degrees of Hepatic Impairment Relative to Healthy Subjects With and Without Overweight/Obesity and 2) Safety and Tolerability of Multiple Subcutaneous Doses of BI 456906 in Patients With Overweight/Obesity With Cirrhosis and Varying Degrees of Hepatic Impairment Relative to Patients With Overweight/Obesity Without Cirrhosis/Hepatic Impairment

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

13

Recruiting sites

—

Enrollment

82

actual

Study population

Healthy volunteers, Hepatic impairment, Obesity / overweight

Key I/E criterion

•BMI 18.5-40

Primary endpoints

•Part•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 IDNCT05296733
Org study ID1404-0010
Secondary ID2021-006247-10

Timeline

Milestones

Study first posted2022-03-25actual
Study start2022-04-27actual
Primary completion2023-12-29actual
Study completion2023-12-29actual
Last update posted2024-08-15actual

Assets

Investigational agents

Survodutide

Study populations

Who this study enrolls

Healthy volunteersHepatic impairmentObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

-Part A:

•Male or female subjects with age ≥18 years (or the minimum country specific age of consent if >18 years) and 75 years, inclusive at the screening visit.
•Body mass index (BMI) of 18.5-40.0 kg/m2 (inclusive).
•Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
•Women of childbearing potential must be willing and able to use two forms of effective contraception where at least one form is highly effective method of birth control per ICH M3 (R2) that results in a low failure rate (i.e. <1% per year when used consistently and correctly). A list of contraception methods meeting these criteria is provided in the subject information. Please note that oral contraceptives are not allowed during the treatment period.

A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

Further inclusion criteria apply.

-Part B:

•Male or female subjects between the ages of ≥18 (or the minimum country specific age of consent if >18 years) and 75 years, inclusive, at the screening visit.
•Subjects with overweight or obesity, defined as BMI ≥27 kg/m2 at the screening visit.
•A minimum absolute body weight of 70 kg for females and 80 kg for males at the screening visit.
•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

-Part A:

•Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula).
•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at screening.
•Calcitonin ≥20 pg/mL (5.84 pmol/L) at the screening visit.
•History of chronic or acute pancreatitis or elevation of serum lipase/amylase >2×ULN, or fasting serum triglyceride levels of >500 mg/dL (>5.65 mmol/L) at screening.

Further exclusion criteria apply.

-Part B:

•Prior surgery of the gastrointestinal tract that could interfere with body weight (including minimally invasive/endoscopic bariatric devices, bariatric surgery including metabolic operation that involves resection and/or reconstruction of any portion of the gastrointestinal tract) except appendectomy and simple hernia repair before randomization. However, a subject previously treated with reversible weight loss devices such as gastric banding, or intragastric balloon and removed longer than 12 months before screening should not be excluded.
•Glycosylated Hemoglobin, Type A1 (HbA1c) ≥11% at screening or diagnosed with type 1 diabetes mellitus.
•Exposure to Glucagon-like-peptide 1 (GLP-1) receptor agonist-based therapies (within 3 months prior to screening or within 5 half-lives of the drug, whichever is longer).
•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at screening.

Further exclusion 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

Part A: 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 360 hours

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Part A: Maximum measured concentration of BI 456906 in plasma (Cmax)

Time frame:Up to 360 hours

Cmax

concentration, descriptive

Primary/protocol endpoint

Part B: Percentage of patients treated who experience treatment-emergent adverse event

Time frame:Up to Day 218

Treatment-emergent AEs (any)

threshold achievement, event

Secondary/protocol endpoint

Part A: Percentage of patients treated who experience treatment-emergent adverse event

Time frame:Up to Day 35

Treatment-emergent AEs (any)

threshold achievement, event

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.