A Study of BGM0504 in Chinese Patients With Type 2 Diabetes

A Randomized, Double-blind, Placebo and Positive Drug Parallel-controlled Phase IIa Clinical Study Protocol to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Multiple-dose BGM0504 Injection in Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06974825

Enrollment

Registered

2025-05-16

Start date

2023-08-30

Completion date

2024-08-13

Last updated

2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

The purpose of this study is to evaluate the efficacy and safety of BGM0504 in Chinese patients with Type 2 Diabetes.

Interventions

DRUGBGM0504 Administered SC

5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

DRUGSemaglutide Administered SC

Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week

DRUGPlacebo Administered SC

Placebo Comparator: Placebo Placebo administered SC once a week.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Have been diagnosed with type 2 diabetes mellitus (T2DM); * Glycosylated hemoglobin (HbA1c) at screening/baseline: 7.0% ≤ HbA1c ≤ 10%; * Body Mass Index (BMI): 19.5 kg/m2 ≤ BMI ≤ 35.0 kg/m2; * Fasting blood glucose (FPG) at screening/baseline: FPG ≤ 13.3 mmoL/L

Exclusion criteria

* Diagnosed with non-type 2 diabetes mellitus; * Grade 3 hypoglycemia within 6 months prior to screening; * Concomitant thyroid dysfunction that cannot be controlled at a stable drug dose at screening, or clinically significant abnormalities in thyroid function test results at screening that require initiation of therapy; * 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; * Patients with a previous history or clinical evidence of acute or chronic pancreatitis; * Malignant tumor confirmed within 5 years prior to screening (except cured carcinoma in situ) or potential malignant tumor assessed at screening; * Patients with severe mental illness or language disorder at screening, unwilling or unable to fully understand and cooperate; * Female subjects during pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Hemoglobin A1c (HbA1c)	Week 0 to Week 12	Change from baseline in HbA1c after 12 weeks of treatment.

Secondary

Measure	Time frame	Description
Change From Baseline in Body Weight	Week 0 to Week 12	Change from baseline in body weight after 12 weeks of treatment.
Percentage of Participants With HbA1c Target Value of <7%	Week 0 to Week 12	Percentage of Participants With HbA1c Target Value of \<7% after 12 weeks of treatment.
Percentage of Participants With HbA1c Target Value of <6.5%	Week 0 to Week 12	Percentage of Participants With HbA1c Target Value of \<5.7% after 12 weeks of treatment.
Change From Baseline in Fasting Serum Glucose	Week 0 to Week 12	Change from baseline in FPG after 12 weeks of treatment.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026