Actively Recruiting
Phase III Clinical Study Comparing the Efficacy and Safety of GZR18 Injection and Semaglutide (Wegovy®) in Adult Obese or Overweight Subjects
Led by Gan & Lee Pharmaceuticals. · Updated on 2025-11-25
420
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase III Clinical Study Comparing the Efficacy and Safety of GZR18 Injection and Semaglutide (Wegovy®) in Adult Obese or Overweight Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older, male or female.
- For those without type 2 diabetes: obese (BMI 28 28 kg/m) or overweight (BMI 24 to <28 kg/m) with at least one condition such as hyperglycemia, hypertension, dyslipidemia, fatty liver, weight-bearing joint pain, or obstructive sleep apnea.
- For those with type 2 diabetes: BMI 24 kg/m, diagnosed with type 2 diabetes for at least 90 days, managed by diet and exercise alone or stable metformin (with or without SGLT2 inhibitors), HbA1c 7.0-10.5%, fasting plasma glucose < 15 mmol/L.
- Managed by diet and exercise alone for at least 12 weeks with less than 5% weight change in that time.
- Women of childbearing potential must not plan pregnancy during the study and must use effective contraception; pregnancy tests must be negative.
- Able to understand study procedures, maintain regular diet and exercise, accept subcutaneous injections, and provide informed consent.
You will not qualify if you...
- For those without type 2 diabetes: fasting plasma glucose 27 7.0 mmol/L or HbA1c 26.5%, any prior diabetes diagnosis (except gestational), prior use of GLP-1R agonists.
- For those with type 2 diabetes: prior use of GLP-1R agonists within 180 days, history of poor response or intolerance to these drugs, recent diabetic ketoacidosis, lactic acidosis, or hyperosmolar hyperglycemic state.
- Severe chronic diabetic complications.
- Recent refractory or complicated urinary/genital infections.
- Allergies to GLP-1 receptor agonists or excipients.
- History of substance or alcohol abuse.
- Limb deformities affecting height measurement.
- Previous or planned bariatric surgery (with specific exceptions).
- Obesity caused by secondary diseases or medications.
- Recent severe hypoglycemia.
- Personal or family history of certain cancers or endocrine neoplasia.
- Other factors deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing
Beijing, China
Actively Recruiting
Research Team
J
Jianbo Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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