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NCT Number: NCT06716203

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

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise.

The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drug: 5 mg BGM0504 Administered SC

Drug

Drug: BGM0504 Administered SC

Drug: : 10 mg BGM0504 Administered SC

Drug

Drug: BGM0504 Administered SC

Drug: Placebo Administered SC

Drug

Drug: Placebo Administered SC

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Week 0 to Week 32

    Change from baseline in HbA1c after 32 weeks of treatment.

Secondary outcomes

  1. Change From Baseline in Body Weight

    Time frame: Week 0 to Week 52

    Change from baseline in body weight after 52 weeks of treatment.

  2. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Week 0 to Week 52

    Change from baseline in HbA1c after 52weeks of treatment.

  3. Percentage of Participants With HbA1c Target Value of <7%

    Time frame: Week 0 to Week 52

    Percentage of Participants With HbA1c Target Value of <7% after 52weeks of treatment.

  4. Percentage of Participants With HbA1c Target Value of <5.7%

    Time frame: Week 0 to Week 52

    Percentage of Participants With HbA1c Target Value of <5.7%after 52weeks of treatment.

  5. Change From Baseline in Fasting Serum Glucose

    Time frame: Week 0 to Week 52

    Change from baseline in FPG after 52 weeks of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Linong Ji,MD, chief physician, Peking University People's Hospital

CONTACT

[email protected]

+86 13910978815

Sponsors and collaborators

Lead sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Industry

Collaborators

  • BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 4, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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