Can a weekly shot ease sleep apnea without a CPAP machine?
NCT ID NCT07767942
First seen Aug 17, 2026 · Last updated Aug 26, 2026 · Updated 3 times
Summary
This phase 3 trial is testing whether an investigational drug called UBT251 can reduce the severity of obstructive sleep apnea in people who are obese and do not use positive airway pressure (PAP) therapy. Participants will receive weekly injections of UBT251 or a placebo for 52 weeks. The main goal is to see if UBT251 lowers the Apnea-Hypopnea Index (AHI), a measure of breathing pauses during sleep. The study also tracks safety and changes in body weight.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- UBT251, an investigational drug given as a weekly injection
- What this could lead to
- If effective, UBT251 could offer a drug-based alternative to CPAP for obese individuals with moderate-to-severe sleep apnea, potentially improving breathing during sleep and reducing related health risks.
- What could go wrong
- This is a phase 3 trial, but results are not yet known. The drug may not significantly reduce apnea events, and side effects from the injection or the drug itself are possible. Success in this trial does not guarantee approval or effectiveness for everyone.
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 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 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 to 75 years
- 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: * Male or female participants aged 18 to 75 years inclusive at the time of signing the informed consent form. * Confirmed diagnosis of obstructive sleep apnea (OSA) based on the International Classification of Sleep Disorders, 3rd Edition, Text Revision (ICSD-3-TR) criteria, with a polysomnography (PSG) showing an Apnea-Hypopnea Index (AHI) ≥ 15 events/hour at screening. * Participants who are unwilling or unsuitable to receive positive airway pressure (PAP) therapy, and who have not received PAP therapy within 4 weeks prior to screening. * Body Mass Index (BMI) ≥ 28 kg/m² at screening. * Weight has been stable for 3 months prior to screening (body weight change \< 5%) (based on self-report). * Participants of childbearing potential and their partners must have no plan for conception from screening until 6 months after completion of the trial, voluntarily use effective contraceptive measures, and have no plan to donate sperm or oocytes within 6 months after trial completion. * Willingness to provide written informed consent and strictly comply with the protocol. Exclusion Criteria: * Known hypersensitivity to the investigational drug, its excipients, or other drugs with similar pharmacological activity. * Use of any of the following within 3 months prior to screening: 1. GLP-1 receptor agonists or similar drugs; 2. biguanides, SGLT-2 inhibitors, DPP-4 inhibitors, or any other hypoglycemic agents; 3. weight-influencing medications (including systemic glucocorticoids, tricyclic antidepressants, antipsychotics, mood stabilizers); 4. over-the-counter weight-loss drugs, prescription weight-loss drugs (e.g., orlistat), or lipolytic injections; stimulants, sedative-hypnotics, opioids, trazodone, or muscle relaxants; 5. medications that may affect excessive daytime sleepiness assessment. * History or evidence of: 1. Diagnosed with type 1 diabetes, type 2 diabetes, or other types of diabetes (except history of gestational diabetes); 2. History of acute or chronic pancreatitis, or pancreatic surgery; 3. History of symptomatic gallbladder disease within 1 year prior to screening; 4. Personal or family history (first-degree relatives, i.e., parents, children, or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2); 5. Presence of endocrine diseases that may significantly affect body weight; 6. History of bariatric surgery or planned weight-loss procedures (with specific exceptions for procedures \>1 year prior); 7. Previous history of depression, or Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at screening, or history of severe mental illness; 8. positive C-SSRS for suicidal ideation/behavior; 9. History of clinically significant cardiovascular or cerebrovascular disease within 6 months; 10. History or presence of severe retinal or macular lesions; 11. History of sleep apnea surgery or major ENT surgery that may still affect breathing; 12. History or presence at screening of clinically relevant medical conditions (other than OSA) or psychiatric disorders related to insomnia or excessive sleepiness; 13. Receiving other active device therapies for OSA; 14. Presence of other sleep disorders besides OSA; 15. History or diagnosis of obesity hypoventilation syndrome or diurnal hypercapnia; 16. Requirement for supplemental oxygen therapy; 17. Severe craniofacial bony deformities or abnormalities significantly affecting the airway; 18. Presence of gastrointestinal motility disorders, gastrointestinal diseases increasing post-dose risks, or history of major gastrointestinal surgery; 19. malignancy within 5 years (except cured skin, cervical, or prostate in situ); 20. Major surgery, severe trauma, or severe infection within 1 month; 21. Concomitant diseases affecting participant safety, efficacy evaluation, or compliance. * Abnormal lab results: 1. HbA1c ≥6.5% or FPG ≥7.0 mmol/L; 2. ALT/AST ≥3×ULN or total bilirubin ≥1.5×ULN or eGFR \<60 mL/min/1.73m²; 3. calcitonin ≥50 pg/mL; 4. uncontrolled thyroid dysfunction or TI-RADS ≥4a nodules; 5. fasting TG ≥5.6 mmol/L; 6. amylase/lipase \>2×ULN; 7. INR \>ULN; 8. hemoglobin \<90 g/L; 9. untreated hypertension (SBP ≥160 and/or DBP ≥100 mmHg); 10. clinically significant ECG abnormalities (2nd/3rd degree AV block, QTcF \>470ms female/\>450ms male, WPW, HR \<50 or \>110); 11. positive HBV-DNA, HCV-RNA, HIV, or dual-positive syphilis; 12. Physical examination, vital signs, laboratory tests, or other assessments showing clinically significant abnormalities that pose a significant risk to the participant or interfere with the evaluation of safety or PK results, rendering the participant unsuitable for the trial. * Participation in another interventional clinical trial within 3 months prior to screening. * Blood loss ≥400 mL or blood transfusion within 3 months prior to screening. * History of drug or alcohol abuse (female \>7 or male \>14 standard drinks/week). * Pregnant or lactating women. * Unable to tolerate venipuncture or history of needle/blood phobia. * Any other condition deemed unsuitable by the investigator.
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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 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.
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