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

NCT06737042 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: GL-GLP-2001
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 20

Brief 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).

Conditions

Obesity and Overweight

Keywords

GLP-1, Obesity, Overweight, Weight loss

Outcome Measures

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

  36 weeks

Study Arms (4)

24 mg GZR18 group

EXPERIMENTAL

24 mg GZR18 group: 76 participants (57 receiving GZR18 and 19 receiving placebo)

Drug: GZR18

36 mg GZR18 group

EXPERIMENTAL

36 mg GZR18 group: 76 participants (57 receiving GZR18 and 19 receiving placebo)

Drug: GZR18

48 mg GZR18 group

EXPERIMENTAL

48 mg GZR18 group: 76 participants (57 receiving GZR18 and 19 receiving placebo)

Drug: GZR18

Tirzepatide group

ACTIVE COMPARATOR

Tirzepatide group: 57 participants receiving 15 mg tirzepatide

Drug: Tirzepatide

Interventions

GZR18 DRUG

GLP-1

24 mg GZR18 group; 36 mg GZR18 group; 48 mg GZR18 group

Tirzepatide DRUG

Active Comparator

Tirzepatide group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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/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.
• Obstructive sleep apnea.
• Cardiovascular disease: defined as having eg, ischemic cardiovascular disease or New York Heart Association (NYHA) Functional Classification Class I to II heart failure.
• \. In the investigator's opinion, are well motivated, capable, and willing to:
• Learn how to self-inject the IP as required for this protocol (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the IP; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IP).
• Inject the IP (or receive an injection from a trained individual if visually impaired or with physical limitations).
• Follow study procedures for the duration of the study, including, but not limited to, lifestyle advice (eg, dietary changes and physical activity plan), complete the electronic diary (eDiary), and complete required questionnaires.
• Identify the biological sex for the study stratification. 5.Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• A self-reported change (increase or decrease) in body weight \>5 kg within 3 months prior to screening.
• Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \>1 year prior to screening).

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (20)

KUR Research - Trinity @ Bessemer, AL Site Network

Bessemer, Alabama, 35022, United States

Location

KUR Research - Trinity @ Centreville Site Network

Centreville, Alabama, 35042, United States

Location

ERG - Woodland Int'l Research Group

Little Rock, Arkansas, 72211, United States

Location

ERG - Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

Ark Clinical Research Ark-Fountain Valley

Fountain Valley, California, 92708, United States

Location

Ark Clinical Research Ark-Long Beach

Long Beach, California, 90815, United States

Location

Clinedge - Central Valley Research, LLC

Modesto, California, 95350, United States

Location

Populace Health, LLC - Catalina Research Institute

Montclair, California, 91763, United States

Location

East Coast Institute for Research - ECIR Jacksonville (Southside)

Jacksonville, Florida, 32216, United States

Location

East Coast Institute for Research ECIR Jacksonville (Headquarters) University

Jacksonville, Florida, 32216, United States

Location

3Sync Research - PCRS Network

Lake Worth, Florida, 33460, United States

Location

Clever Medical Research - PCRS Network

Miami, Florida, 33126, United States

Location

KUR Research @ Columbia Site Network

Columbia, Maryland, 21045, United States

Location

Populace Health, LLC - Elixia SISU

Springfield, Massachusetts, 01103, United States

Location

Populace Health, LLC - Vector Clinical Trials

Las Vegas, Nevada, 89128, United States

Location

Populace Health, LLC - CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

ERG - Ohio Clinical Trials

Columbus, Ohio, 43212, United States

Location

Elligo Clinical Research Center - Austin

Austin, Texas, 78704, United States

Location

Clinvax Katy Research Center

Katy, Texas, 77493, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Central Study Contacts

Kimberly Lazaroff

CONTACT

+888-288-5395; ctgovgl@ganlee.us

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 17, 2024
• Study Start: February 12, 2025
• Primary Completion: February 9, 2026
• Study Completion (Estimated): June 22, 2026
• Last Updated: February 4, 2025

Record last verified: 2024-12

Locations

US (20)