Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Not Treated With Positive Airway Pressure (PAP) Therapy

A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Moderate to Severe Obstructive Sleep Apnea（OSA） Not Treated With Positive Airway Pressure（PAP）

This study is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of GZR18 injection in obese subjects with moderate to severe obstructive sleep apnea who are unable or unwilling to undergo positive airway pressure (PAP) therapy.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Drug: Placebo; Drug: GZR18 injection

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: na ou; Phone Number: 15288850128; Email: na.ou@ganlee.com

Study Locations

• China
  • Beijing, China
    • Gan & Lee Pharmaceuticals
    • Contact: na ou; Phone Number: 15288850128; Email: na.ou@ganlee.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject is aged ≥18 years at the time of signing the informed consent form.
2. Body mass index (BMI) is ≥28 kg/m² at both screening and randomization.
3. Subject has a documented history of at least one unsuccessful attempt at weight loss through dietary control prior to screening, and has had <5% change in body weight during the 12 weeks prior to screening.
4. Subject has been diagnosed with obstructive sleep apnea (OSA) , and has a centrally assessed apnea-hypopnea index (AHI) ≥15 events/hour on polysomnography (PSG) at screening.

5. Unable or unwilling to receive PAP therapy before screening, and not planning to initiate PAP therapy during the study period.

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Exclusion Criteria:

1. Known or suspected hypersensitivity to glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or any of their excipients, or presence of a contraindication to GLP-1 RA use.
2. History of any type of diabetes mellitus (history of gestational diabetes is permitted).
3. Has undergone or plans to undergo during the study period surgical or device-based obesity treatment (exceptions: acupuncture, liposuction, or abdominal fat removal performed >1 year prior to screening; prior device-based obesity treatment is acceptable if the device was removed >1 year before screening).
4. Secondary obesity due to disease, medication, or other causes (e.g., Cushing's syndrome, Prader-Willi syndrome, monogenic obesity, or obesity secondary to hypothalamic/pituitary injury).
5. Clinically significant gastric emptying disorders at screening (e.g., gastroparesis or gastric outlet obstruction); or long-term use (≥4 consecutive weeks) of medications affecting gastrointestinal motility within 6 months prior to screening.
6. History of acute or chronic pancreatitis or pancreatic injury prior to screening.
7. History of symptomatic gallbladder disease at screening (post-cholecystectomy status is permitted); or presence at screening of cholelithiasis conferring high risk for acute biliary pancreatitis.
8. Clinical or subclinical thyrotoxicosis at screening, regardless of treatment status.
9. Inadequately controlled blood pressure at screening or randomization: systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg (concurrent antihypertensive therapy is permitted).
10. History within 6 months prior to screening of: decompensated heart failure (NYHA Class III-IV), unstable angina, myocardial infarction, ischemic or hemorrhagic stroke (lacunar infarcts excluded), transient ischemic attack; or invasive cardiovascular procedures/therapies (e.g., valve replacement, CABG, PCI). (Diagnostic coronary angiography without intervention is permitted.)
11. Positive response on the Columbia-Suicide Severity Rating Scale (C-SSRS) Screening Version to Question 4 or 5 of the "Suicidal Ideation" section, or any question in the "Suicidal Behavior" section, with the event occurring within 4 weeks prior to screening; or investigator assessment of significant suicide risk during the study.
12. History of moderate-to-severe depression; or Patient Health Questionnaire-9 (PHQ-9) score ≥15 at screening.
13. Any uncontrolled acute or chronic hepatitis other than metabolic dysfunction-associated fatty liver disease (MAFLD).
14. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) type 2A or 2B.
15. History of malignancy within 5 years prior to screening (exceptions: definitively cured in situ carcinomas, e.g., basal/squamous cell skin cancer, cervical in situ carcinoma, or prostate in situ carcinoma).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; subcutaneous administration
Experimental: GZR18 injection	Drug: GZR18 injection; subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Apnea-Hypopnea Index (AHI) after 52 weeks of treatment	52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage change in AHI from baseline	52weeks
Proportion of participants with ≥50% reduction in AHI from baseline	52 weeks
Proportion of participants achieving the following criteria：AHI < 5; or 5 ≤ AHI ≤ 14 and Epworth Sleepiness Scale (ESS) score ≤ 10	52 weeks
Percentage change in body weight from baseline	52 weeks
Proportion of subjects whose body weight decreased by ≥ 5%, ≥ 10%, ≥ 15%, or ≥ 20% relative to baseline	52 weeks
Change in body weight (kg) and body mass index (kg/㎡) relative to baseline	52 weeks
Change in neck circumference and waist circumference relative to the baseline	52 weeks
Change in high-sensitivity C-reactive protein (hsCRP) relative to baseline	52 weeks

Collaborators and Investigators

• Sponsor: Gan & Lee Pharmaceuticals.

Study record dates

Study Major Dates

• Study Start (Estimated): April 27, 2026
• Primary Completion (Estimated): November 14, 2027
• Study Completion (Estimated): November 14, 2027

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: obesity; obstructive sleep apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Nutrition Disorders; Overnutrition; Body Weight; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Overweight; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Sleep Apnea, Obstructive
• Other Study ID Numbers: GZR18-OSA-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No