EFFICACY and SAFETY of GZR18 INJECTED EVERY 2 WEEKS (Q2W) in PARTICIPANTS WITHOUT TYPE 2 DIABETES, WHO HAVE OBESITY or ARE OVERWEIGHT: a RANDOMIZED, TIRZEPATIDE- and PLACEBO-CONTROLLED STUDY
Gan and Lee Pharmaceuticals, USA
Summary
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).
Description
This is a Phase 2 multicenter, randomized, parallel-group, partially-blinded, placebo and tirzepatide-controlled study of 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). The study will comprise a 2-week screening period (Days -14 to -1), a 36-week treatment period (Weeks 0 to 36), which includes a titration period and a maintenance dose peri…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 18 to 75 years of age (both inclusive) at the time of signing the informed consent form (ICF). 2. History of failing to lose sufficient weight with lifestyle/dietary modification. BMI ≥30.0 kg/m2, or BMI ≥27.0 kg/m2 with at least 1 of the following: * 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/…
Interventions
- DrugGZR18
GLP-1
- DrugTirzepatide
Active Comparator
Locations (20)
- KUR Research - Trinity @ Bessemer, AL Site NetworkBessemer, Alabama
- KUR Research - Trinity @ Centreville Site NetworkCentreville, Alabama
- ERG - Woodland Int'l Research GroupLittle Rock, Arkansas
- ERG - Woodland Research NorthwestRogers, Arkansas
- Ark Clinical Research Ark-Fountain ValleyFountain Valley, California
- Ark Clinical Research Ark-Long BeachLong Beach, California