Clinical trial NCT06704581: A Study of BGM0504 Injection in Participants with Obesity or Overweight
Official title: A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BGM0504 Injection in Chinese Non-diabetes Participants with Overweight or Obese
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Overweight or Obesity
Lead sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-26
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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, 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

Primary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline,Week 36
measure: Percentage of Participants Who Achieve≥5% Body Weight Reduction
timeFrame: Baseline,Week 36
Secondary outcomes:
measure: Percent Change From Baseline in Body Weight
timeFrame: Baseline, Week 52
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week36 and 52
measure: Percentage of Participants Who Achieve≥5% Body Weight Reduction
timeFrame: Baseline, Week 36 and 52
measure: Percentage of Participants Who Achieve≥10% Body Weight Reduction
timeFrame: Baseline, Week 36 and 52
measure: Percentage of Participants Who Achieve≥15%Body Weight Reduction
timeFrame: Baseline, Week 36 and 52
measure: Percentage of Participants Who Achieve≥20% Body Weight Reduction
timeFrame: Baseline, Week 36 and 52
measure: Change From Baseline in Waist Circumference
timeFrame: Baseline, Week 36 and 52
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 36 and 52
measure: Change From Baseline in Fasting Glucose
timeFrame: Baseline, Week 36 and 52
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 36 and 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: