CompletedPhase 2

A Study Comparing the Effects of BGM0504 Injection and Semaglutide Injection on Obese Subjects.

An Investigator-Initiated, Randomized, Open-Label, Active-Controlled Study Comparing the Effects of BGM0504 Injection Versus Semaglutide Injection on Insulin Sensitivity and Body Weight in Obese Subjects

Lead sponsor

Second Affiliated Hospital of Soochow University

Assets

BGM0504 / Semaglutide

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoints

•HOMA2-β index•HOMA2-IR•MFI

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07836140

Org study IDBGM0504-IIT

Timeline

Milestones

Study start2024-04-22actual

Primary completion2025-04-25actual

Study completion2026-04-30actual

Study first posted2026-09-23actual

Last update posted2026-09-23actual

Assets

Investigational agents

BGM0504 Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•1.Chinese adult participants aged 18 to 65 years (inclusive) with obesity, both male and female; 2.Obese individuals: BMI ≥ 30.0 kg/m², or BMI ≥ 27.0 kg/m² with at least one weight-related comorbidity (such as prediabetes, dyslipidemia, fatty liver disease, obstructive sleep apnea syndrome, metabolic abnormalities, etc.); 3.Prior to screening, participants must have maintained weight control through diet and exercise alone for at least 12 weeks, with a reported weight change of less than 5.0%, and must be able to continue their existing diet and exercise regimen for weight management throughout the trial period； 4.MRI (Magnetic Resonance Imaging scan) has no contraindications (e.g., use of pacemakers and metal implants, or claustrophobia that hinders completion of the MRI examination)； 5.Fully understand the purpose, nature, methods, and potential adverse reactions of the trial, be capable of completing the trial in accordance with the protocol requirements, voluntarily serve as a study participant, and sign the informed consent form； 6.Individuals who, from the time of signing the informed consent form until one month after the conclusion of the study, have no plans for pregnancy, voluntarily adopt effective contraceptive measures to prevent pregnancy or impregnation of their partner, and have no plans to donate sperm or eggs； Note: The percentage change in body weight is calculated as follows: (Body weight 12 weeks prior to screening - Body weight at screening) / Body weight 12 weeks prior to screening × 100%.

Exclusion criteria

•1.Subjects with uncontrolled hypertension at screening (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening) or those with untreated blood pressure meeting the above criteria； 2.During screening, there was thyroid dysfunction that could not be controlled with a stable medication dose, or thyroid function test results showed clinically significant abnormalities requiring the initiation of treatment； 3.During screening, abdominal ultrasound indicates the presence of gallstones or polyps, or there are clinical symptoms of gallbladder disease at the time of screening； 4.During screening, severe chronic complications of diabetes requiring acute treatment are identified, such as diabetic nephropathy, proliferative retinopathy, or non-proliferative diabetic retinopathy; peripheral vascular disease leading to amputation, chronic foot ulcers, or intermittent claudication; and painful diabetic neuropathy； 5.It is known that the individual has an allergic constitution (allergic to three or more foods or medications), is allergic to GLP-1 receptor agonist drugs, or suffers from severe allergic diseases (asthma, urticaria, eczema, dermatitis, etc.) during screening； 6.Individuals with a history of severe diseases affecting the nervous, respiratory, immune, hepatic, renal, or other organ systems are deemed unsuitable for participation in the trial based on investigator assessment； 7.Individuals with severe mental illness or language barriers who are unwilling or unable to fully understand and cooperate during screening； 8.Individuals who tested positive for drugs in urine screening or alcohol in breath testing at baseline； 9.History of substance abuse； 10.Select individuals who have participated in any clinical study within the past three months and received intervention with an investigational drug or medical device； 11.Female subjects who are pregnant or breastfeeding； Note：The researchers believe that the subject has any other factors that would make participation in this trial inappropriate.

Endpoints (20)

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.

Coverage by outcome category

Other (unclassified)

Cardiometabolic biomarkers

Glycemic / diabetes

Weight & body composition

MASH / liver

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Fasting weight

Time frame:Target dose at week 16

descriptive

Secondary/protocol endpoint

Visceral fat

Time frame:Target dose at week 16

descriptive

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Fasting insulin

Time frame:Target dose at week 16

descriptive

Secondary/protocol endpoint

Fasting blood glucose

Time frame:Target dose at week 16

descriptive

Secondary/protocol endpoint

Fasting C-peptide

Time frame:Target dose at week 16

descriptive

Secondary/protocol endpoint

OGTT

Time frame:At 30 minutes, 60 minutes, and 120 minutes compared to the baseline.

descriptive

MASH / liver

1 endpoint

Secondary/protocol endpoint

Liver fat

Time frame:Target dose at week 16

descriptive

Cardiometabolic biomarkers

6 endpoints

Secondary/protocol endpoint

Serum uric acid (UA)

Time frame:Target dose at week 16

descriptive

Secondary/protocol endpoint

Triglycerides (TG)

Time frame:Target dose at week 16

descriptive

Secondary/protocol endpoint

Cholesterol (TC)

Time frame:Target dose at week 16

descriptive

Secondary/protocol endpoint

Low-density lipoprotein (LDL-C)

Time frame:Target dose at week 16

descriptive

Secondary/protocol endpoint

High-density lipoprotein (HDL-C)

Time frame:Target dose at week 16

descriptive

Secondary/protocol endpoint

Free Fatty Acids (FFA)

Time frame:Target dose at week 16

descriptive

Other (unclassified)

7 endpoints

Primary/protocol endpoint/low confidence

HOMA2-β index

Time frame:Target dose at week 16

descriptive

Primary/protocol endpoint/low confidence

HOMA2-IR

Time frame:Target dose at week 16

descriptive

Primary/protocol endpoint/low confidence

MFI

Time frame:Target dose at week 16

descriptive

Secondary/protocol endpoint/low confidence

Fasting glucagon

Time frame:Target dose at week 16

descriptive

Secondary/protocol endpoint/low confidence

ACTH and cortisol

Time frame:Target dose at week 16

descriptive

Secondary/protocol endpoint/low confidence

Fat-free muscle volume (thigh skeletal muscle)

Time frame:Target dose at week 16

descriptive

Secondary/protocol endpoint/low confidence

Subcutaneous fat

Time frame:Target dose at week 16

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.