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CompletedPhase 2

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

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

NCT IDNCT06973681
Org study IDBGM0504-II-WL

Timeline

Milestones

Study start2023-10-13actual
Primary completion2024-09-13actual
Study completion2024-09-13actual
Study first posted2025-05-15actual
Last update posted2025-05-15actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. BMI ≥ 28.0 kg/m2 or 24.0 ≤ BMI < 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit; 2.Controlled by diet and exercise alone for at least 12 weeks prior to Screening with <5.0% change in body weight and able to continue the original diet and exercise for weight control during the trial.

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
Glycemic / diabetes
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

Percentage change in body weight

Time frame:Week 0 to Week 24

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Proportion of Subjects with weight loss of ≥5%

Time frame:Week 0 to Week 24

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference

Time frame:Week 0 to Week 24

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in BMI

Time frame:Week 0 to Week 24

BMI, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change 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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 July 1, 2026 snapshot.