Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apne… (NCT07501832) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Receiving Positive Airway Pressure (PAP) Therapy
China140 participantsStarted 2026-03-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
What they're measuring
1
Change from baseline in Apnea-Hypopnea Index (AHI) after 52 weeks of treatment
. 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.