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Completed

NCT Number: NCT06973681

A Study of BGM0504 Evaluating Weight Loss in Overweight or Obese Chinese Subjects

To assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.

Completed

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Third Xiangya Hospital of Central South University

Changsha, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. BMI ≥ 28.0 kg/m2 or 24.0 ≤ BMI < 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit; 2.Controlled by diet and exercise alone for at least 12 weeks prior to Screening with <5.0% change in body weight and able to continue the original diet and exercise for weight control during the trial.

Exclusion criteria

1.Those who have used weight loss drugs within 12 weeks before screening; 2. Previous diagnosis of type 1 or type 2 diabetes mellitus; 3. History of acute or chronic pancreatitis, or pancreatic injury; 4. History of thyroid C-cell carcinoma, MEN (multiple endocrine adenomatosis) 2A or 2B, or relevant family history; 5. Subjects with uncontrolled hypertension after treatment (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening) or untreated blood pressure meeting the above criteria at screening; 6. Concomitant thyroid dysfunction that cannot be controlled at a stable drug dose atscreening, or clinically significant abnormalities in thyroid function test results at screening that require initiation of therapy; 7. At Screening, abdominal ultrasound indicated calculus gallbladder and polyps, or presence of clinical symptoms of gallbladder disease at Screening; 8. Pregnant or breastfeeding women.

Treatment and study plan

BGM0504

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

  1. Percentage change in body weight

    Time frame: Week 0 to Week 24

    Percentage change from baseline in body weight after 24 weeks of treatment.

Secondary outcomes

  1. Proportion of Subjects with weight loss of ≥5%

    Time frame: Week 0 to Week 24

    Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment

  2. Change from baseline in waist circumference

    Time frame: Week 0 to Week 24

    Change from baseline in waist circumference after 24 weeks of treatment

  3. Change from baseline in BMI

    Time frame: Week 0 to Week 24

    Change from baseline in BMI after 24 weeks of treatment

  4. Change from baseline in fasting plasma glucose (FPG)

    Time frame: Week 0 to Week 24

    Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment

Sponsors and collaborators

Lead sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study to Evaluate the Safety, Tolerability, PK/PD Profile, and Efficacy of Multiple Doses of BGM0504 Injection in Overweight or Obese Subjects Without Diabetes

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 15, 2025
Registry last updated
May 15, 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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