Clinical trial NCT06716203: A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
First posted: 2024-12-04
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Week 0 to Week 32
Secondary outcomes:
measure: Change From Baseline in Body Weight
timeFrame: Week 0 to Week 52
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Week 0 to Week 52
measure: Percentage of Participants With HbA1c Target Value of <7%
timeFrame: Week 0 to Week 52
measure: Percentage of Participants With HbA1c Target Value of <5.7%
timeFrame: Week 0 to Week 52
measure: Change From Baseline in Fasting Serum Glucose
timeFrame: Week 0 to Week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: