About this trial
This is a Phase 2 study to evaluate the safety and efficacy of 24, 36, and 48 mg GZR18 (Q2W) compared with placebo and 15 mg tirzepatide (QW). The study will evaluate weight management in participants with obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with weight-related comorbidities (excluding type 2 diabetes mellitus).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 to 75 years of age (both inclusive) at the time of signing the informed consent form (ICF).
History of failing to lose sufficient weight with lifestyle/dietary modification.
Hypertension: defined as taking blood pressure (BP) lowering medication or have a systolic blood pressure (SBP) of ≥130 mmHg or a diastolic blood pressure (DBP) of ≥80 mmHg at screening.
Dyslipidemia: defined as taking lipid-lowering medication or have LDL ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) <40 mg/dL (1.0 mmol/L) for men or HDL <50 mg/dL (1.3 mmol/L) for women at screening.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
GZR18
DrugGLP-1
Tirzepatide
DrugActive Comparator
Treatment groups
Trial outcomes
Primary outcomes
Primary Objective
To demonstrate that GZR18 24 mg, 36 mg, and 48 mg is superior to placebo based on percentage change in body weight after 36 weeks of treatment
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: