Clinical trial
A Study of BGM0504 in Participants With Obesity
Recruiting now · Phase 2 · 1 countries · Registry ID NCT06911203
Recruiting nowPhase 2Interventional
What this study is about
To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity
Full registry 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.
Treatments and study arms
BGM0504
Drug
Administered SC
Tirzepatide
Drug
Administered SC
Primary outcomes
Change From Baseline in Body WeightWeek 0, Week 26
Change from baseline in body weight after 26 weeks of treatment
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Peking University People's Hospital🇨🇳 Beijing, Beijing Municipality, China
Linong JiContact