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

Completed · Phase 2

Conditions studied: Obesity and Overweight

In brief

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).

Key facts

Study ID

NCT06737042

Run by

Gan and Lee Pharmaceuticals, USA

People needed

326

Starts

2025-02-24

Expected to finish

2026-02-27

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Exclusion Medical Conditions Related to Obesity
• 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).
• Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening, including but not limited to:
• Mucosal ablation
• Gastric artery embolization
• Intragastric balloon
• Duodenal-jejunal endoluminal liner Related to Diabetes
• History of type 1 or T2DM, history of ketoacidosis, or hyperosmolar state/coma.
• At least 1 laboratory value suggestive of diabetes during screening, including 1 or more of HbA1c ≥6.5% (48 mmol/mol), fasting serum glucose ≥126 mg/dL (7.0 mmol/L), or random glucose ≥200 mg/dL (11.1 mmol/L).
• Other Medical Conditions
• Renal impairment measured as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, calculated by chronic kidney disease-epidemiology collaboration (CKD-EPI) as determined by central laboratory during screening.

Where it is running

• KUR Research - Trinity @ Bessemer, AL Site Network — Bessemer, Alabama, United States
• KUR Research - Trinity @ Centreville Site Network — Centreville, Alabama, United States
• ERG - Woodland Int'l Research Group — Little Rock, Arkansas, United States
• ERG - Woodland Research Northwest — Rogers, Arkansas, United States
• Ark Clinical Research Ark-Fountain Valley — Fountain Valley, California, United States
• Ark Clinical Research Ark-Long Beach — Long Beach, California, United States
• Clinedge - Central Valley Research, LLC — Modesto, California, United States
• Populace Health, LLC - Catalina Research Institute — Montclair, California, United States
• East Coast Institute for Research - ECIR Jacksonville (Southside) — Jacksonville, Florida, United States
• East Coast Institute for Research ECIR Jacksonville (Headquarters) University — Jacksonville, Florida, United States
• 3Sync Research - PCRS Network — Lake Worth, Florida, United States
• Clever Medical Research - PCRS Network — Miami, Florida, United States
• KUR Research @ Columbia Site Network — Columbia, Maryland, United States
• Populace Health, LLC - Elixia SISU — Springfield, Massachusetts, United States
• Populace Health, LLC - Vector Clinical Trials — Las Vegas, Nevada, United States
• Populace Health, LLC - CTI Clinical Research Center — Cincinnati, Ohio, United States
• ERG - Ohio Clinical Trials — Columbus, Ohio, United States
• Elligo Clinical Research Center - Austin — Austin, Texas, United States
• Clinvax Katy Research Center — Katy, Texas, United States
• Endeavor Clinical Trials — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.