BridgeMD
Compares treatment options for Obesity/Overweight in Adult
Official title Phase III Clinical Study Comparing the Efficacy and Safety of GZR18 Injection and Semaglutide (Wegovy®) in Adult Obese or Overweight Subjects
ClinicalTrials.gov ID: NCT07150975
What this study is testing
What is GZR18?
GZR18 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obesity/overweight in adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a multicenter, randomized, open-label, parallel-group phase III clinical trial comparing the efficacy and safety of GZR18 Injection and semaglutide (Wegovy®) in adult obese or overweight subjects, aiming to evaluate the efficacy and safety of GZR18 Injection in this population.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged ≥ 18 years old (based on the date of signing the informed consent form), male or female.
- For people not diagnosed with type 2 diabetes at screening, the following criteria must be met: At screening and Visit 2 (before randomization), the...
- Comorbidity of one or more of the following: hyperglycemia (see Appendix 1 for definition), hypertension, dyslipidemia (see Appendix 2 for...
- Weight-related obstructive sleep apnea syndrome.
- For people with type 2 diabetes at screening, the following criteria must be met simultaneously: Body mass index (BMI) ≥ 24 kg/m² at both screening...
You likely can't join if
- For people without type 2 diabetes at screening, the following situations are excluded:
- Fasting plasma glucose ≥ 7.0 mmol/L or glycated hemoglobin (HbA1c) ≥ 6.5% as measured by the central laboratory at screening.
- Diagnosis of any type of diabetes (excluding gestational diabetes) prior to screening.
- Use of glucagon-like peptide-1 receptor (GLP-1R) agonists or drugs with a GLP-1R agonist mechanism of action (e.g., GLP-1R/glucagon receptor (GCGR)...
- For people with type 2 diabetes at screening, the following situations are excluded:
- Use of glucagon-like peptide-1 receptor (GLP-1R) agonists or drugs with a GLP-1R agonist mechanism of action (e.g., GLP-1R/glucagon receptor (GCGR)...
See the full eligibility criteria
- Aged ≥ 18 years old (based on the date of signing the informed consent form), male or female.
- For people not diagnosed with type 2 diabetes at screening, the following criteria must be met: At screening and Visit 2 (before randomization), the subject must be either obese (BMI ≥ 28 kg/m²) or overweight (24 kg/m²...
- Comorbidity of one or more of the following: hyperglycemia (see Appendix 1 for definition), hypertension, dyslipidemia (see Appendix 2 for definition), or fatty liver; ②Weight-bearing joint pain;
- Weight-related obstructive sleep apnea syndrome.
- For people with type 2 diabetes at screening, the following criteria must be met simultaneously: Body mass index (BMI) ≥ 24 kg/m² at both screening and Visit 2 (before randomization); A confirmed diagnosis of type 2...
- Prior to screening, the subject has been managed by diet and exercise alone for at least 12 weeks, and the body weight change has been \< 5% within the past 12 weeks (based on self-report).
- people of childbearing potential must have no childbearing plans from the time of signing the informed consent form to 8 weeks after the last dose, and voluntarily adopt effective contraceptive measures, with no plans...
- The subject must be able to understand the procedures and methods of this study, be willing and able to maintain a regular diet and exercise lifestyle during the study period, be willing and able to receive subcutaneous...
- For people without type 2 diabetes at screening, the following situations are excluded:
- Fasting plasma glucose ≥ 7.0 mmol/L or glycated hemoglobin (HbA1c) ≥ 6.5% as measured by the central laboratory at screening.
- Diagnosis of any type of diabetes (excluding gestational diabetes) prior to screening.
- Use of glucagon-like peptide-1 receptor (GLP-1R) agonists or drugs with a GLP-1R agonist mechanism of action (e.g., GLP-1R/glucagon receptor (GCGR) agonists, glucose-dependent insulinotropic polypeptide receptor...
- For people with type 2 diabetes at screening, the following situations are excluded:
- Use of glucagon-like peptide-1 receptor (GLP-1R) agonists or drugs with a GLP-1R agonist mechanism of action (e.g., GLP-1R/glucagon receptor (GCGR) agonists, glucose-dependent insulinotropic polypeptide receptor...
- A history of diabetic ketoacidosis, lactic acidosis, or hyperosmolar hyperglycemic state within 180 days prior to screening.
- Presence of severe chronic diabetic complications at screening (e.g., proliferative retinopathy or macular edema, painful diabetic neuropathy, intermittent claudication, or diabetic foot).
- A history of refractory or complicated urinary tract infections/genital infections within 6 months prior to screening.
- people with known or suspected allergies to glucagon-like peptide-1 (GLP-1) receptor agonists or their excipients.
- A history of substance abuse prior to screening.
- A history of alcohol abuse within 180 days prior to screening, defined as an average weekly alcohol intake exceeding 14 units (for males)/7 units (for females) (1 standard unit is equivalent to 360 mL of beer, 150 mL of...
- Presence of limb deformities or disabilities that affect height measurement.
- Previous receipt of bariatric surgery prior to screening, or planned receipt of bariatric surgery during the study period (exceptions include acupuncture for weight loss, liposuction, or abdominal liposuction performed...
- Obesity caused by secondary diseases or medications, including: elevated cortisol (e.g., Cushing's syndrome), obesity due to pituitary or hypothalamic damage, etc.
- A history of severe hypoglycemia or grade 3 hypoglycemia within 180 days prior to screening.
- A personal history or relevant family history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) type 2A or 2B prior to screening; or a history of malignant tumors within the past 5 years (excluding...
- The investigator deems that the subject has any other factors that may affect the evaluation of how well it works or safety in this study, making them unsuitable for participation. \-
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.