Evaluate the Pharmacokinetics, Pharmacodynamics, Safety a... | NCT06714955

Studies
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection in Non-diabetic Overweight or Obese Adult Subjects

NCT06714955

Sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Status

Completed

Last Update Posted

Sep 22, 2025Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Non-diabetic Overweight or Obese

Interventions

Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.
Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 21, 2024Actual

Primary Completion Date

Jan 21, 2025Actual

Completion Date

Mar 3, 2025Actual

First Submitted Date

Nov 27, 2024

First Submission Date that Met QC Criteria

Nov 27, 2024

First Posted Date

Dec 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2025

Last Update Posted Date

Sep 22, 2025Actual

Description Module

Brief Summary

This is a Phase 1, double-blind, parallel-arm ,placebo-controlled study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), safety and tolerability of BGM0504 following multiple subcutaneous (SC) administrations in non-diabetic overweight or obese adult subjects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.	Experimental	Drug: BGM0504 Administered SC	Drug: Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.	Experimental	Drug: BGM0504 Administered SC	Drug: Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.
Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.	Placebo Comparator	Drug: Placebo Administered SC	Drug: Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.	Drug	Drug: BGM0504 Administered SC	Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of treatment adverse events	The relationship of each adverse event tothe investigational product was assessed by the investigator	10 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic endpoint: Concentration of BGM0504 in plasma		10 weeks
Change in fasting weight at week 10		10 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body mass index (BMI) meeting one of the following requirements:
1. Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese); OR
2. Between ≥ 27.0 kg/m2 and < 30.0 kg/m2 (overweight) with at least 1 of the following: 1) One or more of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia; 2) Weight-bearing joint pain; 3) Obesity causing dyspnea or obstructive sleep apnea syndrome
Have a stable body weight (<5% self-reported change during the previous 8 weeks) before screening
Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.

Exclusion Criteria:

Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to glucagon-like peptide-1 (GLP-1) receptor agonists, or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).
Have received GLP-1 receptor agonists or similar drugs containing the same target within 12 weeks before screening.
Have received drugs that have an impact on body weight within 12 weeks before screening.
Surgical treatment for obesity.
Known type I/II diabetes.
History of acute or chronic pancreatitis or pancreatic injury.
History of drug abuse or alcoholism at screening.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms