NCT06716203Active, not recruitingPhase 3
A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
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
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 207 (estimated)
- First submitted
- 29 Nov 2024
- Start date
- 3 Jan 2025
- Primary completion date
- 14 Nov 2026
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT06716203
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 207
- From 3 Jan 2025 to the primary completion date, 14 Nov 2026
- 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
- ■ 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.
Who the study is looking for
- ☑ 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.