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Completed

NCT Number: NCT07836140

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

semaglutide

Drug

Multiple ascending doses of semaglutide administered SC

BGM0504 Administered SC

Drug

Multiple ascending doses of BGM0504 administered SC

Primary outcomes

  1. HOMA2-β index

    Time frame: Target dose at week 16

    Change in the HOMA2-β (steady-state model for beta-cell function assessment) index from baseline at Week 16 of the target dosage

  2. HOMA2-IR

    Time frame: Target dose at week 16

    Change in the HOMA2-IR (homeostasis model assessment of insulin resistance) index from baseline at Week 16 of the target dose

  3. MFI

    Time frame: Target dose at week 16

    Target dose: relative percentage change in skeletal muscle fat infiltration (MFI) from baseline at Week 16

Secondary outcomes

  1. Fasting insulin

    Time frame: Target dose at week 16

    Change from baseline in fasting insulin levels at week 16 following administration of the target dose

  2. Fasting blood glucose

    Time frame: Target dose at week 16

    Change from baseline in fasting blood glucose at week 16 of the target dose administration

  3. Fasting C-peptide

    Time frame: Target dose at week 16

    Change in fasting C-peptide from baseline at Week 16 after administration of the target dose

  4. Fasting glucagon

    Time frame: Target dose at week 16

    change in fasting glucagon from baseline at Week 16 after administration of the target dose

  5. OGTT

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

    Changes in blood glucose, insulin, C-peptide, and glucagon at 30 minutes, 60 minutes, and 120 minutes after oral glucose administration compared to baseline

  6. Fasting weight

    Time frame: Target dose at week 16

    The relative percentage change in fasting weight from baseline at Week 16 after administration of the target dose

  7. Serum uric acid (UA)

    Time frame: Target dose at week 16

    Change in serum uric acid from baseline at Week 16 of target-dose administration

  8. Triglycerides (TG)

    Time frame: Target dose at week 16

    Change in triglycerides from baseline at Week 16 after administration of the target dose

  9. Cholesterol (TC)

    Time frame: Target dose at week 16

    Change in cholesterol from baseline at Week 16 after administration of the target dose

  10. Low-density lipoprotein (LDL-C)

    Time frame: Target dose at week 16

    Change in low-density lipoprotein from baseline at Week 16 of targeted dosing

  11. High-density lipoprotein (HDL-C)

    Time frame: Target dose at week 16

    Change in high-density lipoprotein from baseline at Week 16 after targeted dosing

  12. Free Fatty Acids (FFA)

    Time frame: Target dose at week 16

    Change in free fatty acids from baseline at Week 16 after administration of the target dose

  13. ACTH and cortisol

    Time frame: Target dose at week 16

    Changes in ACTH and cortisol from baseline at Week 16 of targeted dosing

  14. Fat-free muscle volume (thigh skeletal muscle)

    Time frame: Target dose at week 16

    Change in fat-free muscle volume from baseline at Week 16 after administration of the target dose

  15. Visceral fat

    Time frame: Target dose at week 16

    The relative percentage change in visceral fat from baseline at Week 16 after administration of the target dose

  16. Subcutaneous fat

    Time frame: Target dose at week 16

    The relative percentage change from baseline in subcutaneous fat at Week 16 following administration of the target dose

  17. Liver fat

    Time frame: Target dose at week 16

    The relative percentage change in liver fat from baseline at Week 16 after administration of the target dose

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Soochow University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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