Recruiting NCT06911203
A Study of BGM0504 in Participants With Obesity
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: BGM0504, Tirzepatide.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 65 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 II, Randomized Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BGM0504 Compared to Tirzepatide in Adults Who Have Obesity
Overview
To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.
Interventions
- Drug BGM0504
Administered SC - Drug Tirzepatide
Administered SC
Primary outcome measures
- Change From Baseline in Body Weight [Time frame: Week 0, Week 26]
Secondary outcome measures (5)
- Change From Baseline in BMI [Time frame: Week 18, Week 26]
- Change From Baseline in Waist Circumference [Time frame: Week 18, Week 26]
- Change from Baseline in Systolic Blood Pressure (SBP) [Time frame: Week 18, Week 26]
- Change from Baseline in Diastolic Blood Pressure (DBP) [Time frame: Week 18, Week 26]
- Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) [Time frame: Week 0, Week 26]
Eligibility criteria
Inclusion criteria
- ● Able and willing to provide a written informed consent.
- Male or female subjects, 18-65 years of age at the time of signing informed consent.
- At screening visit, 35.0 ﹤BMI﹤ 45.0 kg/m2;
- Diet and exercise control for at least 3 months before screening visit, and be of stable weight (± 5%) self-reported change within the last 3 months.
Exclusion criteria
- ●History of chronic or acute pancreatitis.
- History of severe drug allergy or specific allergic disease or severe allergies.
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2(MEN-2).
- History of malignant tumors \[except carcinoma in situ with no recurrence within 5 years (except for malignant melanoma in situ), skin basal cell carcinoma and squamous cell carcinoma\].
- Suspected or confirmed history of alcohol or drug abuse;
- Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).
- Donation or loss of 400 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 3 months after the end of the trial.
- Pregnant or lactating woman.
- Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
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: NCT06911203 · BGM0504-II -WL-02