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

NCT06929156 | Completed Phase 1 FDA Drug

• 1 other identifier: BGM0504-I-101
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess how fast BGM0504 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.

Conditions

Type 2 Diabetes Mellitus (T2DM); Overweight or Obese

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Tlast (AUC0-t)

  Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Tlast (AUC0-t)

  Start of Treatment up to Day 29

• Maximum Concentration of BGM0504 (Cmax)

  Maximum Concentration of BGM0504 (Cmax)

  Start of Treatment up to Day 29

• Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Infinity (AUC0-inf)

  Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Infinity (AUC0-inf)

  Start of Treatment up to Day 29

Secondary Outcomes (4)

• Time to maximum concentration (Tmax)

  Start of Treatment up to Day 29

• Apparent terminal half-life (t1/2)

  Start of Treatment up to Day 29

• Apparent clearance (CL/F)

  Start of Treatment up to Day 29

• Incidence and severity of adverse events

  Screening period up to Day 29

Study Arms (4)

A group (Healthy Control)

EXPERIMENTAL

Drug: BGM0504

B group (Mild Renal Impairment)

EXPERIMENTAL

Drug: BGM0504

C group (Moderate Renal Impairment)

EXPERIMENTAL

Drug: BGM0504

D group (Severe Renal Impairment)

EXPERIMENTAL

Drug: BGM0504

Interventions

BGM0504 DRUG

Receive a single dose of BGM0504 injection

A group (Healthy Control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• √ 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):
• Normal renal function: 90-129 mL/min (inclusive);
• Mild impairment: 60-89 mL/min (inclusive);
• Moderate impairment: 30-59 mL/min (inclusive);
• Severe impairment: 15-29 mL/min (inclusive);

You may not qualify if:

• ● 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.

Sponsors & Collaborators

• BrightGene Bio-Medical Technology Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)

Jinan, Shandong, 650100, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: May 6, 2025
• Primary Completion: December 25, 2025
• Study Completion: December 25, 2025
• Last Updated: February 11, 2026

Record last verified: 2025-02

Locations

CN (1)