A Study of BGM0504 in Participants With Obesity
ConditionObesity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrightGene Bio-Medical Technology Co., Ltd.
About this trial
To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.
Eligibility criteria
Qualifiers
● 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.
Disqualifiers
●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].
Trial design
Treatments tested in this trial
- BGM0504
- Tirzepatide
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov