Efficacy and Safety of GZR18 Every 2 Weeks Versus Tirzepatide and Placebo in Obese or Overweight Participants

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGan and Lee Pharmaceuticals, USA

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • GZR18

    Drug

    GLP-1

  • Tirzepatide

    Drug

    Active Comparator

Treatment groups

285 Participants
are divided into 4 treatment groups
Group A: 24 mg GZR18 groupExperimental treatment 1 intervention
Group B: 36 mg GZR18 groupExperimental treatment 1 intervention
Group C: 48 mg GZR18 groupExperimental treatment 1 intervention
Group D: Tirzepatide groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
36 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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