A Phase 2 interventional study of semaglutide and BGM0504 Administered SC in Obesity / Overweight, sponsored by Second Affiliated Hospital of Soochow University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Second Affiliated Hospital of Soochow University · Phase 2, Interventional, and Basic science
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Among 10 studies testing BGM0504 in Obesity — none open to participants now, none under way, none of them phase 3. BGM0504 · Obesity.
Among the 10 studies testing BGM0504 in Obesity, this one is the 7th largest by enrollment, is one of 3 that started in 2024, is one of 3 in phase 2, and was the 10th registered.
11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.
Browse Obesity studies →None of the 10 studies testing BGM0504 in Obesity is open now. The open studies under Obesity, anywhere →
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 1,339 Obesity studies recruiting now, 377 (28%) set no upper age limit and 859 (64%) stop at 75 or younger; 167 take children under 18; 490 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2023; this study’s year is marked. 3 started in 2024.
This study's enrollment of 60 is below the median of 67 across 9,016 interventional studies indexed under Obesity.
Median enrollment 78 across the 10 interventional studies. Of the 10 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 10 have an industry lead sponsor. The 3 most frequent:
Second Affiliated Hospital of Soochow University is the lead sponsor of 62 studies on the registry; 33 are open to participants now.
Second Affiliated Hospital of Soochow University has 1 study filed under Obesity — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies testing BGM0504 in Obesity, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Multiple ascending doses of Semaglutide administered SC
Drug: semaglutide
Multiple ascending doses of BGM0504 administered SC
Drug: BGM0504 Administered SC
Multiple ascending doses of semaglutide administered SC
Multiple ascending doses of BGM0504 administered SC
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
Time frame: Target dose at week 16
HOMA2-IR
Change in the HOMA2-IR (homeostasis model assessment of insulin resistance) index from baseline at Week 16 of the target dose
Time frame: Target dose at week 16
MFI
Target dose: relative percentage change in skeletal muscle fat infiltration (MFI) from baseline at Week 16
Time frame: Target dose at week 16
Fasting insulin
Change from baseline in fasting insulin levels at week 16 following administration of the target dose
Time frame: Target dose at week 16
Fasting blood glucose
Change from baseline in fasting blood glucose at week 16 of the target dose administration
Time frame: Target dose at week 16
Fasting C-peptide
Change in fasting C-peptide from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
Fasting glucagon
change in fasting glucagon from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
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
Time frame: At 30 minutes, 60 minutes, and 120 minutes compared to the baseline.
Fasting weight
The relative percentage change in fasting weight from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
Serum uric acid (UA)
Change in serum uric acid from baseline at Week 16 of target-dose administration
Time frame: Target dose at week 16
Triglycerides (TG)
Change in triglycerides from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
Cholesterol (TC)
Change in cholesterol from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
Low-density lipoprotein (LDL-C)
Change in low-density lipoprotein from baseline at Week 16 of targeted dosing
Time frame: Target dose at week 16
High-density lipoprotein (HDL-C)
Change in high-density lipoprotein from baseline at Week 16 after targeted dosing
Time frame: Target dose at week 16
Free Fatty Acids (FFA)
Change in free fatty acids from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
ACTH and cortisol
Changes in ACTH and cortisol from baseline at Week 16 of targeted dosing
Time frame: Target dose at week 16
Fat-free muscle volume (thigh skeletal muscle)
Change in fat-free muscle volume from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
Visceral fat
The relative percentage change in visceral fat from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
Subcutaneous fat
The relative percentage change from baseline in subcutaneous fat at Week 16 following administration of the target dose
Time frame: Target dose at week 16
Liver fat
The relative percentage change in liver fat from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2024 to primary completion in Apr 2025, 12 months.
Of 131 non-industry phase 2 interventional studies under Obesity, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 57. This study's 12 months is below that.
Counting every sponsor, half of 307 studies reached it within 16 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: BGM0504
Second Affiliated Hospital of Soochow University