New injection could ease sleep apnea and aid weight loss
NCT ID NCT07501832
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests an injection called GZR18 in 140 obese adults with moderate-to-severe obstructive sleep apnea who already use a breathing machine (PAP). The goal is to see if the drug improves breathing during sleep, reduces weight, and boosts quality of life compared to a placebo. It is a Phase 3 trial, meaning it is in the final stages before possible approval.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GZR18 injection
- What this could lead to
- If it works, this could offer a new treatment that reduces sleep apnea severity and helps with weight loss in obese patients.
- What could go wrong
- This is an early-stage Phase 3 trial with only 140 participants, so results may not apply to everyone. The drug may cause side effects or not improve sleep apnea significantly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 (see Appendix 2 for the weight change calculation formula). 4. 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.) 5. 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. 6. 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. 7. 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: 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gan & Lee Pharmaceuticals
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New mask aims to make sleep apnea therapy easier to live with
- Can a weekly phone call keep sleep apnea patients on CPAP?
- A smart neck brace may replace CPAP for sleep apnea
- A blood test for liver trouble may flag hidden risk in sleep apnea patients
- Blood oxygen dips may reveal who stays on CPAP
- Can a simple questionnaire improve sleep apnea treatment?