DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06716203

RecruitingPhase 3

A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of BGM0504 Versus Placebo in Patients with Type 2 Diabetes, Inadequately Controlled with Diet and Exercise Alone

Asset

BGM0504

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

207

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥23•HbA1c 7.5-11%

Primary endpoint

•HbA1c, 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 IDNCT06716203
Org study IDBGM0504-Ⅲ -T2DM-01

Timeline

Milestones

Study start2024-12-02actual
Study first posted2024-12-04actual
Last update posted2025-02-07actual
Primary completion2025-12-29estimated
Study completion2026-08-25estimated

Assets

Investigational agents

BGM0504

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•☑ Have been diagnosed with type 2 diabetes mellitus (T2DM);
–Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
–Be of stable weight (± 5%) for at least 3 months before screening;
–Have HbA1c between ≥7.5% and ≤11.0%；
–Fasting Plasma Glucose (FPG) ≤ 15.0 mmoL/L.

Exclusion criteria

•■ Previous diagnosis of type 1 diabetes, special type diabetes ;
–There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).
–Have had chronic or acute pancreatitis any time prior to study entry;
–Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;
–Mentally incapacitated or speech-impaired;
–Suspected or confirmed history of alcohol or drug abuse;
–Pregnant or lactating woman;
–The investigator considers that there are any other conditions that make it inappropriate to participate in this study.

Endpoints (6)

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

Glycemic / diabetes
5
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Week 0 to Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Week 0 to Week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Week 0 to Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants With HbA1c Target Value of <7%

Time frame:Week 0 to Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants With HbA1c Target Value of <5.7%

Time frame:Week 0 to Week 52

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose

Time frame:Week 0 to Week 52

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.