A Study of BGM0504 in Participants With Obesity

Last updated: October 27, 2025
Sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Obesity

Diabetes Prevention

Treatment

Tirzepatide

BGM0504

Clinical Study ID

NCT06911203
BGM0504-II -WL-02
  • Ages 18-65
  • All Genders

Study Summary

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

Inclusion

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 informedconsent.

  • At screening visit, 35.0 ﹤BMI﹤ 45.0 kg/m2;

  • Diet and exercise control for at least 3 months before screening visit, and beof stable weight (± 5%) self-reported change within the last 3 months.

Exclusion

Exclusion Criteria:

  • ●History of chronic or acute pancreatitis.

  • History of severe drug allergy or specific allergic disease or severeallergies.

  • Family or personal history of medullary thyroid carcinoma (MTC) or multipleendocrine 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 andsquamous cell carcinoma].

  • Suspected or confirmed history of alcohol or drug abuse;

  • Any chronic infections likely to interfere with study conduct or interpretationsuch 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 thetrial.

  • Pregnant or lactating woman.

  • Any disorder, unwillingness, or inability not covered by any of the otherexclusion criteria, which in the Investigator's opinion, might jeopardize theparticipant's safety or compliance with the protocol.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Tirzepatide
Phase: 2
Study Start date:
April 03, 2025
Estimated Completion Date:
January 11, 2026

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing 1816670, Beijing Municipality 2038349 100044
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.