A Study of BGM0504 Injection in Participants with Obesity or Overweight
Recruiting
Phase 3Interventional Study
Overweight or Obesity
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
620 (estimated)
Sponsor
BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd. · Industry
Who this trial is looking for
This trial is looking for adults in China who are overweight or obese. Participants will receive the BGM0504 injection alongside diet, exercise, and behavioral support for weight management.
Are You a Good Fit for This Trial?
Rules you outDiabetes mellitusPancreatitis
You may be able to join if
I am between 18 and 65 years old.
I have a BMI of 28 or higher, or a BMI between 24.0 and 28.0 with certain health issues.
I have not lost more than 5.0% of my weight through diet and exercise in the last 12 weeks.
I am not pregnant or breastfeeding.
I am using effective birth control if I can get pregnant.
You may not be able to join if
I have diabetes.
I am allergic to three or more foods or medications.
I have been treated with certain weight control medications in the last three months.
I have been diagnosed with conditions causing obesity due to medical reasons.
I have a history of pancreatitis.
I have uncontrolled thyroid disease.
I have had moderate or severe depression, or serious mental illness.
I have attempted suicide in the past.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is a multicenter, randomized, double-blind, placebo-controlled phase III validation clinical study in Chinese adult non-diabetic overweight or obese Participants. The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and behavioral interventions in overweight or obese non-diabetic adults in China for weight m…
This is a multicenter, randomized, double-blind, placebo-controlled phase III validation clinical study in Chinese adult non-diabetic overweight or obese Participants. The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and behavioral interventions in overweight or obese non-diabetic adults in China for weight management, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* A male or female aged 18 to 65 years inclusive at screening
* BMI≥28 kg/m², or 24.0≤BMI\<28.0 kg/m² and previous diagnosis with at least one of the following comorbidities: i. Prediabetes (impaired fasting blood glucose and/or impaired glucose tolerance), hypertension, nonalco…
Inclusion Criteria:
* A male or female aged 18 to 65 years inclusive at screening
* BMI≥28 kg/m², or 24.0≤BMI\<28.0 kg/m² and previous diagnosis with at least one of the following comorbidities: i. Prediabetes (impaired fasting blood glucose and/or impaired glucose tolerance), hypertension, nonalcoholic fatty liver disease, or one or more of these; ii. Joint pain with weight bearing; iii. Dyspnea caused by obesity or obstructive sleep apnea syndrome
* Weight change \< 5.0% (chief complaint) after diet and exercise control for at least 12 weeks before screening
* Female participants who are not pregnant or lactating. Female participants with childbearing potential and their partners should use highly effective, medically accepted contraception, will not have pregnancy and fertility plan, and refrain from donating ovum until one month after the end of the study
Exclusion Criteria:
* Diabetes mellitus
* Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening
* Has been treated with GLP-1 receptor agonists or similar drugs containing the same target, or drugs used for weight control in the three months prior to screening
* Secondary disease or drug-induced obesity, including : elevated cortisol (e.g. Cushing's syndrome), obesity due to pituitary and hypothalamic damage, obesity due to diet drug reduction/discontinuation, etc.;
* History of pancreatitis
* Have the currently uncontrolled thyroid diseases with stable treatment dose and clinically significant abnormal results of thyroid function test occurred at screening
* Previous history of moderate or severe depression, or PHQ-9 score ≥15, or history of other serious mental illness, or Any lifetime history of a suicide attempt
Contacts
Ji,MD, chief physician, Peking University People's Hospital
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