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Recruiting NCT06716216

A Study of BGM0504 in Participants with Type 2 Diabetes

Phase III Interventional Type 2 Diabetes Mellitus (T2DM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Drug: 5 mg BGM0504 Administered SC, Drug:10 mg BGM0504 Administered SC, Drug: Semaglutide Administered SC.
Who it may be relevant to
Registry conditions: Type 2 Diabetes Mellitus (T2DM). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Drug Drug: 5 mg BGM0504 Administered SC
    Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
  • Drug Drug:10 mg BGM0504 Administered SC
    Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.
  • Drug Drug: Semaglutide Administered SC
    Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week

Primary outcome measures

  • Change From Baseline in Hemoglobin A1c (HbA1c) [Time frame: Week 0 to Week 32]
Secondary outcome measures (5)
  • Change From Baseline in Body Weight [Time frame: Week 0 to Week 52]
  • Change From Baseline in Hemoglobin A1c (HbA1c) [Time frame: Week 0 to Week 52]
  • Percentage of Participants With HbA1c Target Value of <7% [Time frame: Week 0 to Week 52]
  • Percentage of Participants With HbA1c Target Value of <5.7% [Time frame: Week 0 to Week 52]
  • Change From Baseline in Fasting Serum Glucose [Time frame: Week 0 to Week 52]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University People's Hospital — Beijing

Identifiers

NCT: NCT06716216 · BGM0504-Ⅲ -T2DM-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗