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Obesity / OverweightPhase 2NCT07836140

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

A Phase 2 study testing semaglutide and BGM0504 Administered SC in people with Obesity / Overweight, run by Second Affiliated Hospital of Soochow University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity / Overweight
What is being tested?
semaglutide and BGM0504 Administered SC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
22 Apr 2024to 30 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

Other trials in China

About this study

Official 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

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

Being tested
semaglutide, BGM0504 Administered SC
Keywords
Obesity
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • semaglutideDrug

    Multiple ascending doses of semaglutide administered SC

  • BGM0504 Administered SCDrug

    Multiple ascending doses of BGM0504 administered SC

Study groups in NCT07836140
Study groupRoleWhat they receive
SemaglutideActive comparatorMultiple ascending doses of Semaglutide administered SC
Receives: Drug: semaglutide
BGM0504ExperimentalMultiple ascending doses of BGM0504 administered SC
Receives: Drug: BGM0504 Administered SC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HOMA2-β index

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

    Measured: Target dose at week 16

  2. HOMA2-IR

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

    Measured: Target dose at week 16

  3. MFI

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

    Measured: Target dose at week 16

Secondary outcomes (17)

  1. Fasting insulin

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

    Measured: Target dose at week 16

  2. Fasting blood glucose

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

    Measured: Target dose at week 16

  3. Fasting C-peptide

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

    Measured: Target dose at week 16

  4. Fasting glucagon

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

    Measured: Target dose at week 16

  5. OGTT

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

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

  6. Fasting weight

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

    Measured: Target dose at week 16

  7. Serum uric acid (UA)

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

    Measured: Target dose at week 16

  8. Triglycerides (TG)

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

    Measured: Target dose at week 16

  9. Cholesterol (TC)

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

    Measured: Target dose at week 16

  10. Low-density lipoprotein (LDL-C)

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

    Measured: Target dose at week 16

  11. High-density lipoprotein (HDL-C)

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

    Measured: Target dose at week 16

  12. Free Fatty Acids (FFA)

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

    Measured: Target dose at week 16

  13. ACTH and cortisol

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

    Measured: Target dose at week 16

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

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

    Measured: Target dose at week 16

  15. Visceral fat

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

    Measured: Target dose at week 16

  16. Subcutaneous fat

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

    Measured: Target dose at week 16

  17. Liver fat

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

    Measured: Target dose at week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2026
  2. Study start22 Apr 2024
  3. Primary completion25 Apr 2025
  4. Study completion30 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07836140
Sponsor's protocol ID
BGM0504-IIT
Status last verified
Sep 2026
First submitted
17 Sep 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing semaglutide and BGM0504 Administered SC in people with Obesity / Overweight, run by Second Affiliated Hospital of Soochow University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HOMA2-β index (time frame: Target dose at week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07836140.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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