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NCT06974825CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 16 May 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
67 (actual)
First submitted
14 May 2025
Start date
30 Aug 2023
Primary completion date
13 Aug 2024
Lead sponsor
BrightGene Bio-Medical Technology Co., Ltd.
NCT number
NCT06974825

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 67
  • From 30 Aug 2023 to the primary completion date, 13 Aug 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;
  • 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;

Other illness

  • Diagnosed with non-type 2 diabetes mellitus;
  • 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 severe mental illness or language disorder at screening, unwilling or unable to fully understand and cooperate;

Other

  • Female subjects during pregnancy or lactation.

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Third Xiangya Hospital of Central South University
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.