DelfaGLP-1 Atlas

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RecruitingPhase 3

A Study of BGM0504 Injection in Participants with Obesity or Overweight

A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BGM0504 Injection in Chinese Non-diabetes Participants with Overweight or Obese

Asset

BGM0504

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

620

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥28

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

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 IDNCT06704581
Org study IDBGM0504-Ⅲ-WL

Timeline

Milestones

Study start2024-10-28actual
Study first posted2024-11-26actual
Last update posted2024-11-26actual
Primary completion2025-11-27estimated
Study completion2026-03-27estimated

Assets

Investigational agents

BGM0504

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•A male or female aged 18 to 65 years inclusive at screening
•BMI≥28 kg/m², or 24.0≤BMI<28.0 kg/m² and previous diagnosis with at least one of the following comorbidities:
i.Prediabetes (impaired fasting blood glucose and/or impaired glucose tolerance), hypertension, nonalcoholic fatty liver disease, or one or more of these;
ii.Joint pain with weight bearing;
iii.Dyspnea caused by obesity or obstructive sleep apnea syndrome
•Weight change < 5.0% (chief complaint) after diet and exercise control for at least 12 weeks before screening
•Female participants who are not pregnant or lactating. Female participants with childbearing potential and their partners should use highly effective, medically accepted contraception, will not have pregnancy and fertility plan, and refrain from donating ovum until one month after the end of the study

Exclusion criteria

•Diabetes mellitus
•Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening
•Has been treated with GLP-1 receptor agonists or similar drugs containing the same target, or drugs used for weight control in the three months prior to screening
•Secondary disease or drug-induced obesity, including : elevated cortisol (e.g. Cushing's syndrome), obesity due to pituitary and hypothalamic damage, obesity due to diet drug reduction/discontinuation, etc.;
•History of pancreatitis
•Have the currently uncontrolled thyroid diseases with stable treatment dose and clinically significant abnormal results of thyroid function test occurred at screening
•Previous history of moderate or severe depression, or PHQ-9 score ≥15, or history of other serious mental illness, or Any lifetime history of a suicide attempt

Endpoints (12)

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
10
Glycemic / diabetes
2

Weight & body composition

10 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline,Week 36

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Percentage of Participants Who Achieve≥5% Body Weight Reduction

Time frame:Baseline,Week 36

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week36 and 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve≥5% Body Weight Reduction

Time frame:Baseline, Week 36 and 52

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve≥10% Body Weight Reduction

Time frame:Baseline, Week 36 and 52

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve≥15%Body Weight Reduction

Time frame:Baseline, Week 36 and 52

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve≥20% Body Weight Reduction

Time frame:Baseline, Week 36 and 52

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline, Week 36 and 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 36 and 52

BMI, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Fasting Glucose

Time frame:Baseline, Week 36 and 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 36 and 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

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.