GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function

A Multi-center, Single-dose, Open-label, Parallel Design, Pharmacokinetics Study of BGM0504 Injection in Healthy Participants and Participants With Impaired Renal Function

Lead sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Asset

BGM0504

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criteria

•BMI 19-30•eGFR ≥3

Primary endpoints

•AUC of BGM0504•Cmax of BGM0504(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 IDNCT06929156

Org study IDBGM0504-I-101

Timeline

Milestones

Study first posted2025-04-16actual

Study start2025-05-06actual

Primary completion2025-12-25actual

Study completion2025-12-25actual

Last update posted2026-02-11actual

Assets

Investigational agents

BGM0504

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•√ Age 18-65 years on the date of signing informed consent (inclusive);

–Body mass index (BMI) within the range of 19.0-30.0 kg/m2 (inclusive);.

–Stable renal function, assessed by two eGFR during screening (apart at least 3 days);

–Diagnosed as stable, chronic renal disease for at least 3 months.

–Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):

1. Normal renal function: 90-129 mL/min (inclusive);

2. Mild impairment: 60-89 mL/min (inclusive);

3. Moderate impairment: 30-59 mL/min (inclusive);

4. Severe impairment: 15-29 mL/min (inclusive);

Exclusion criteria

•● Allergic constitution includes severe drug allergy or history of drug allergy;

–Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2; Have a history or presence of pancreatitis;

–Participants in clinical trials of any drug or medical device in the 3 months prior to screening;.

–Suspected or confirmed history of alcohol or drug abuse;

–Hepatitis B surface antigen (HBsAg), HIV antibody detection, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;

–Donation or loss of 200 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 1 months after the end of the trial;

–Pregnant or Breast-feeding women;

–The investigator considers that the participant has any other factors that would make it inappropriate to participate in this study.

Endpoints (7)

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.