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NCT Number: NCT06911203

A Study of BGM0504 in Participants With Obesity

To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BGM0504

Drug

Administered SC

Tirzepatide

Drug

Administered SC

Primary outcomes

  1. Change From Baseline in Body Weight

    Time frame: Week 0, Week 26

    Change from baseline in body weight after 26 weeks of treatment

Secondary outcomes

  1. Change From Baseline in BMI

    Time frame: Week 18, Week 26

    Change from baseline in BMI after 26 weeks of treatment

  2. Change From Baseline in Waist Circumference

    Time frame: Week 18, Week 26

    Change from baseline in waist circumference after 26 weeks of treatment

  3. Change from Baseline in Systolic Blood Pressure (SBP)

    Time frame: Week 18, Week 26

    Change from Baseline in SBP after 26 weeks of treatment

  4. Change from Baseline in Diastolic Blood Pressure (DBP)

    Time frame: Week 18, Week 26

    Change from Baseline in DBP after 26 weeks of treatment

  5. Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)

    Time frame: Week 0, Week 26

    Change from Baseline in IWQOL-Lite-CT after 26 weeks of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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