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A Study of BGM0504 Evaluating Weight Loss in Overweight or Obese Chinese Subjects
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study to Evaluate the Safety, Tolerability, PK/PD Profile, and Efficacy of Multiple Doses of BGM0504 Injection in Overweight or Obese Subjects Without Diabetes
Lead sponsor
Asset
BGM0504
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
120
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥28
Primary endpoint
•Body weight, % change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
1.Those who have used weight loss drugs within 12 weeks before screening; 2. Previous diagnosis of type 1 or type 2 diabetes mellitus; 3. History of acute or chronic pancreatitis, or pancreatic injury; 4. History of thyroid C-cell carcinoma, MEN (multiple endocrine adenomatosis) 2A or 2B, or relevant family history; 5. Subjects with uncontrolled hypertension after treatment (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening) or untreated blood pressure meeting the above criteria at screening; 6. Concomitant thyroid dysfunction that cannot be controlled at a stable drug dose atscreening, or clinically significant abnormalities in thyroid function test results at screening that require initiation of therapy; 7. At Screening, abdominal ultrasound indicated calculus gallbladder and polyps, or presence of clinical symptoms of gallbladder disease at Screening; 8. Pregnant or breastfeeding women.
Endpoints (5)
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
Weight & body composition
4 endpointsPercentage change in body weight
Time frame:Week 0 to Week 24
Body weight, % change
percent change from baseline, improvement
Proportion of Subjects with weight loss of ≥5%
Time frame:Week 0 to Week 24
≥5% weight-loss responders
threshold achievement, improvement
Change from baseline in waist circumference
Time frame:Week 0 to Week 24
Waist circumference, change
change from baseline, improvement
Change from baseline in BMI
Time frame:Week 0 to Week 24
BMI, change
change from baseline, improvement
Glycemic / diabetes
1 endpointChange from baseline in fasting plasma glucose (FPG)
Time frame:Week 0 to Week 24
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Provenance
Sources
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 July 1, 2026 snapshot.