DelfaGLP-1 Atlas

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CompletedPhase 1

Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection in Non-diabetic Overweight or Obese Adult Subjects

A Phase 1, Double-Blind, Parallel-arm, Placebo-Controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection Administered Subcutaneously in Non-diabetic Overweight or Obese Adult Subjects

Asset

BGM0504

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

—

Enrollment

30

actual

Study population

Obesity / overweight

Key I/E criterion

—

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 IDNCT06714955
Org study IDBGM0504-P1-001-US

Timeline

Milestones

Study start2024-10-21actual
Study first posted2024-12-04actual
Primary completion2025-01-21actual
Study completion2025-03-03actual
Last update posted2025-09-22actual

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

•Body mass index (BMI) meeting one of the following requirements:

1. Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese); OR

2. Between ≥ 27.0 kg/m2 and < 30.0 kg/m2 (overweight) with at least 1 of the following: 1) One or more of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia; 2) Weight-bearing joint pain; 3) Obesity causing dyspnea or obstructive sleep apnea syndrome

•Have a stable body weight (<5% self-reported change during the previous 8 weeks) before screening
•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.

Exclusion criteria

•Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to glucagon-like peptide-1 (GLP-1) receptor agonists, or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).
•Have received GLP-1 receptor agonists or similar drugs containing the same target within 12 weeks before screening.
•Have received drugs that have an impact on body weight within 12 weeks before screening.
•Surgical treatment for obesity.
•Known type I/II diabetes.
•History of acute or chronic pancreatitis or pancreatic injury.
•History of drug abuse or alcoholism at screening.

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 10

Time frame:10 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:10 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetic endpoint: Concentration of BGM0504 in plasma

Time frame:10 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.