DelfaGLP-1 Atlas

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RecruitingPhase 1

A Study of BGM0504 Tablets in Healthy and Non-diabetic Overweight or Obese Chinese Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BGM0504 Tablets Orally Administered in Healthy and Non-diabetic Overweight or Obese Chinese Subjects.

Asset

BGM0504

Oral · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

75

estimated

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI ≤28•Healthy volunteers

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT07239973
Org study IDBGM0504-CPK-101

Timeline

Milestones

Study start2025-10-21actual
Study first posted2025-11-20actual
Last update posted2025-11-20actual
Primary completion2026-03-31estimated
Study completion2026-03-31estimated

Assets

Investigational agents

BGM0504

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Between the ages of 18 and 65 years (inclusive) at the time of screening , healthy and non-diabetic overweight or obese subjects , both male and female;
•Healthy subjects , male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 20.0 kg/m² ≤ BMI < 28 kg/m²（BMI = weight/height²）;
•Obese individuals: BMI ≥ 28.0 kg/m², or overweight individuals: 24.0 kg/m² ≤ BMI < 28.0 kg/m²;
•(Medical Inquiry) Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening.
•Have no history of mental disorders, be able to communicate smoothly with Investigator, Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.
•Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) plus an additional medically acceptable form of contraception (female partner) for the duration of the study and for at least 3 months after dosing; must also agree to refrain from sperm donation for at least 3 months post dose

Exclusion criteria

•Those with a history of severe drug allergies (especially those with known or suspected allergies to the active ingredients and excipients of BGM0504 Tablets), or complicated with severe specific allergic diseases/history, or with a severe allergic constitution.
•Subjects with positive results for HBsAg, anti-HCV, anti-HIV or anti-TP during the screening period.
•At the screening/baseline period, any one of the laboratory test indicators meets the following criteria:

1. fasting serum glucose≥ 7.0mmol/L, or post-prandial glucose (PPG)-2h≥ 11.1mmol/L in oral glucose tolerance test (OGTT); (During screening, participants with fasting serum glucose ranging from 6.1 to 6.9mmol/L shall undergo the OGTT.)

2. ALT, AST ≥ 2.5 times upper limit of normal (ULN) or total bilirubin ≥ 1.5 times upper limit of normal (ULN)

3. Glomerular filtration rate (eGFR) ≤ 80 mL/min/1.73 m2(using CKD-EPI formula) or positive urine protein 2+ or more.

4. Serum calcitonin level ≥ 35 ng/L (pg/mL);

5. Thyroid-stimulating hormone (TSH) > 6.0mIU/L or < 0.4mIU/L;

6. Fasting triglycerides ≥ 5.64mmol/L (500 mg/dL);

7. Hemoglobin (Hgb) < 100 g/L (for females) or < 110 g/L (for males);

•12-lead ECG shows ventricular heart rate < 50 beats/min or > 100 beats/min at screening/baseline, second or third degree atrioventricular block, long QT syndrome, QTcF> 470ms for women or > 450ms for men, pre-excitation syndrome or other significant arrhythmias.
•Used illegal drugs within 6 months prior to screening, or substance abuse within 12 months prior to screening.
•Participated in drug or medical device clinical trials and treated with Study Drug (excluding placebo) or medical device intervention within 12 weeks before screening.
•Participants who have received any vaccine within 2 weeks prior to screening, or plan to receive a vaccine during the trial.
•Female participants who are pregnant or lactating, or those with a positive pregnancy test result during the screening period.
•Positive urine drug test or alcohol serum test result at screening or at baseline.
•Has any other conditions or disorders deemed unsuitable for including in the study, in the opinion of the Investigator.

Endpoints (3)

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

Safety / tolerability / PK
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in fasting weight at week 8

Time frame:8 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Number of treatment adverse events

Time frame:8 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetic endpoint: Concentration of BGM0504 in plasma

Time frame:8 weeks

Plasma concentration (steady state)

concentration, descriptive

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.