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NCT Number: NCT06716216

A Study of BGM0504 in Participants with Type 2 Diabetes

This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes

Recruiting

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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);
  • Metformin is used in screening : 1) After used stable-dose metformin (≥1500 mg/day) or maximum tolerated (< 1500mg but≥1000mg daily) for 8 weeks before screening; 2)Metformin treatment dose <1500mg/day at Screening and have not reached the maximum tolerated dose ;3) Metformin combined with daily fixed-dose sulfonylureas (minimum therapeutic dose on the drug label) had been stable for ≥8 weeks when entering the induction period.
  • 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%;

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

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

Drug:10 mg BGM0504 Administered SC

Drug

Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.

Drug: Semaglutide Administered SC

Drug

Active Comparator: 1 mg Semaglutide

1 mg semaglutide administered SC once a week

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 Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly As Add-on Therapy to Metformin And/or Sulfonylureas in Patients with Type 2 Diabetes

Important dates

Study start
2024
Primary completion
2026
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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