A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Receiving Positive Airway Pressure (PAP) Therapy

NCT07501832 | Not Yet Recruiting Phase 3

• 1 other identifier: GZR18-OSA-302
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of GZR18 injection in Chinese adult obese patients with moderate-to-severe obstructive sleep apnea (OSA) who are currently using positive airway pressure (PAP) therapy. This study will assess the impact of GZR18 on OSA-related symptoms, respiratory parameters, and quality of life compared to placebo.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

• Change in AHI from baseline after 52 weeks of treatment

  52 weeks

Secondary Outcomes (3)

• Proportion of participants with ≥50% reduction in AHI from baseline

  52weeks

• Proportion of participants achieving the following criteria：AHI < 5; or 5 ≤ AHI ≤ 14 and Epworth Sleepiness Scale (ESS) score ≤ 10

  52weeks

• Percentage change in body weight from baseline

  52weeks

Study Arms (2)

GZR18 injection

EXPERIMENTAL

Drug: GZR18 injection

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GZR18 injection DRUG

subcutaneous administration

GZR18 injection

Placebo DRUG

subcutaneous administration

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject is aged ≥18 years at the time of signing the informed consent form.
• Body mass index (BMI) is ≥28 kg/m² at both screening and randomization.
• 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 (see Appendix 2 for the weight change calculation formula).
• Subject has been diagnosed with obstructive sleep apnea (OSA) according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria prior to screening, and has a centrally assessed apnea-hypopnea index (AHI) ≥15 events/hour on polysomnography (PSG) at screening. (See Appendix 3 for ICSD-3 diagnostic criteria for adult OSA.)
• Subject has been receiving continuous positive airway pressure (PAP) therapy for at least 12 consecutive weeks prior to screening and intends to continue PAP therapy throughout the study period.
• Subjects of childbearing potential must agree to remain abstinent or use highly effective contraception from the time of signing informed consent until 8 weeks after the last dose of investigational product, and must not donate sperm or oocytes during this period. Female subjects of childbearing potential must not be lactating and must have a negative pregnancy test at both screening and randomization.
• The subject fully understands the purpose, nature, methods, and potential adverse reactions of the trial; is able to communicate effectively with the investigator; comprehends and agrees to comply with all study requirements; and voluntarily signs the informed consent form to participate in this study.

You may not qualify if:

• 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.
• History of any type of diabetes mellitus (history of gestational diabetes is permitted).
• 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).
• 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).
• 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.
• History of acute or chronic pancreatitis or pancreatic injury prior to screening.
• 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.
• Clinical or subclinical thyrotoxicosis at screening, regardless of treatment status.
• Inadequately controlled blood pressure at screening or randomization: systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg (concurrent antihypertensive therapy is permitted).
• 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.)
• 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.
• History of moderate-to-severe depression; or Patient Health Questionnaire-9 (PHQ-9) score ≥15 at screening.
• Any uncontrolled acute or chronic hepatitis other than metabolic dysfunction-associated fatty liver disease (MAFLD).
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) type 2A or 2B.
• 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).

Sponsors & Collaborators

• Gan & Lee Pharmaceuticals.: lead

Study Sites (1)

Gan & Lee Pharmaceuticals

Beijing, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

na ou

CONTACT

15288850128; na.ou@ganlee.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): September 28, 2028
• Study Completion (Estimated): September 28, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CN (1)