Obstructive Sleep Apnea, ObesityPhase 3UNISHAPE-OSA-1NCT07767942
UBT251 Injection Phase Ⅲ Study (OSA-NPAP)
A Phase 3 study testing UBT251 in people with Obstructive Sleep Apnea, Obesity, run by The United Bio-Technology (Hengqin) Co., Ltd..
Trial summary
The objective of this clinical trial is to evaluate the efficacy of investigational drug UBT251 in the treatment of moderate-to-severe obstructive sleep apnea (OSA) with obesity, as well as to assess its safety. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea, Obesity
- What is being tested?
- UBT251
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 18 Sep 2026to Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- GLP-1 receptor agonists or similar drugs;
- biguanides, SGLT-2 inhibitors, DPP-4 inhibitors, or any other hypoglycemic agents;
- weight-influencing medications (including systemic glucocorticoids, tricyclic antidepressants, antipsychotics, mood stabilizers);
- over-the-counter weight-loss drugs, prescription weight-loss drugs (e.g., orlistat), or lipolytic injections; stimulants, sedative-hypnotics, opioids, trazodone, or muscle relaxants;
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- medications that may affect excessive daytime sleepiness assessment.
- History or evidence of:
- Diagnosed with type 1 diabetes, type 2 diabetes, or other types of diabetes (except history of gestational diabetes);
- History of acute or chronic pancreatitis, or pancreatic surgery;
- History of symptomatic gallbladder disease within 1 year prior to screening;
- 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);
- Presence of endocrine diseases that may significantly affect body weight;
- History of bariatric surgery or planned weight-loss procedures (with specific exceptions for procedures >1 year prior);
- Previous history of depression, or Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at screening, or history of severe mental illness;
- positive C-SSRS for suicidal ideation/behavior;
- History of clinically significant cardiovascular or cerebrovascular disease within 6 months;
- History or presence of severe retinal or macular lesions;
- History of sleep apnea surgery or major ENT surgery that may still affect breathing;
- History or presence at screening of clinically relevant medical conditions (other than OSA) or psychiatric disorders related to insomnia or excessive sleepiness;
- Receiving other active device therapies for OSA;
- Presence of other sleep disorders besides OSA;
- History or diagnosis of obesity hypoventilation syndrome or diurnal hypercapnia;
- Requirement for supplemental oxygen therapy;
- Severe craniofacial bony deformities or abnormalities significantly affecting the airway;
- Presence of gastrointestinal motility disorders, gastrointestinal diseases increasing post-dose risks, or history of major gastrointestinal surgery;
- malignancy within 5 years (except cured skin, cervical, or prostate in situ);
- Major surgery, severe trauma, or severe infection within 1 month;
- Concomitant diseases affecting participant safety, efficacy evaluation, or compliance.
- Abnormal lab results:
- HbA1c ≥6.5% or FPG ≥7.0 mmol/L;
- ALT/AST ≥3×ULN or total bilirubin ≥1.5×ULN or eGFR <60 mL/min/1.73m²;
- calcitonin ≥50 pg/mL;
- uncontrolled thyroid dysfunction or TI-RADS ≥4a nodules;
- fasting TG ≥5.6 mmol/L;
- amylase/lipase >2×ULN;
- INR >ULN;
- hemoglobin <90 g/L;
- untreated hypertension (SBP ≥160 and/or DBP ≥100 mmHg);
- clinically significant ECG abnormalities (2nd/3rd degree AV block, QTcF >470ms female/>450ms male, WPW, HR <50 or >110);
- positive HBV-DNA, HCV-RNA, HIV, or dual-positive syphilis;
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of UBT251 Injection in Obese Participants With Moderate-to-severe Obstructive Sleep Apnea (OSA) Not on Positive Airway Pressure (PAP) Therapy（UNISHAPE-OSA-1）
The objective of this clinical trial is to evaluate the efficacy of investigational drug UBT251 in the treatment of moderate-to-severe obstructive sleep apnea (OSA) with obesity, as well as to assess its safety. The key research question is:
Does UBT251 reduce the Apnea-Hypopnea Index (AHI) in participants?
UBT251 will be compared with placebo (an inactive substance identical in appearance) to determine its efficacy in treating moderate-to-severe OSA.
Participants will:
Receive weekly subcutaneous injections of either UBT251 or placebo for a duration of 52 weeks
Undergo examinations and testing at protocol-specified visit windows
Have their AHI assessed following the 52-week treatment period
- Conditions
- Obstructive Sleep Apnea, Obesity
- Being tested
- UBT251, Placebo
- Keywords
- obstructive sleep apnea, obesity, GLP-1, GIP, GCG
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBT251Drug
Administered SC
UBT251Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| UBT251 Dose 1 | Experimental | Participants will receive UBT251 subcutaneously (SC). Receives: Drug: UBT251 |
| UBT251 Dose 2 | Experimental | Participants will receive UBT251 subcutaneously (SC). Receives: Drug: UBT251 |
| Placebo | Placebo comparator | Participants will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Apnea-Hypopnea Index (AHI)
Measured: Baseline, Week 52
Secondary outcomes (8)
Percentage change from baseline in AHI
Measured: Baseline, Week 52
Percentage of participants with a reduction in AHI ≥ 50% from baseline
Measured: Baseline, Week 52
Percentage of participants with an AHI < 5 events/hour or an AHI ≥ 5 and ≤ 14 events/hour with an Epworth Sleepiness Scale (ESS) score ≤ 10
Measured: Baseline, Week 52
Percentage change from baseline in body weight
Measured: Baseline, Week 52
Percentage of participants with a reduction in AHI ≥ 50% from baseline and a reduction in body weight ≥ 10% from baseline
Measured: Baseline, Week 20, Week 52
Percentage change from baseline in the Sleep Apnea-Specific Hypoxia Burden (SASHB)
Measured: Baseline, Week 20, Week 52
Change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a and PROMIS Sleep Disturbance Short Form 8b scores
range: 0 to 100 for both scales; higher scores indicate worse sleep-related impairment and worse sleep disturbance, respectively
Measured: Baseline, Week 20, Week 52
Percentage of participants with improvement in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
range: 0 to 1; higher scores indicate better health-related quality of life
Measured: Baseline, Week 20, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start18 Sep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea, ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767942
- Sponsor's protocol ID
- TUL-UBT251（III-4）202604
- Acronym
- UNISHAPE-OSA-1
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of UBT251 Injection in Obese Participants With Moderate-to-severe Obstructive Sleep Apnea (OSA) Not on Positive Airway Pressure (PAP) Therapy（UNISHAPE-OSA-1）
- ClinicalTrials.gov ID
- NCT07767942
- Acronym / sponsor ID
- UNISHAPE-OSA-1 / TUL-UBT251（III-4）202604
- Conditions
- Obstructive Sleep Apnea, Obesity
- Keywords
- obstructive sleep apnea, obesity, GLP-1, GIP, GCG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial is to evaluate the efficacy of investigational drug UBT251 in the treatment of moderate-to-severe obstructive sleep apnea (OSA) with obesity, as well as to assess its safety. The key research question is:
Does UBT251 reduce the Apnea-Hypopnea Index (AHI) in participants?
UBT251 will be compared with placebo (an inactive substance identical in appearance) to determine its efficacy in treating moderate-to-severe OSA.
Participants will:
Receive weekly subcutaneous injections of either UBT251 or placebo for a duration of 52 weeks
Undergo examinations and testing at protocol-specified visit windows
Have their AHI assessed following the 52-week treatment period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UBT251 Dose 1 | Experimental | Drug: UBT251Participants will receive UBT251 subcutaneously (SC). |
| UBT251 Dose 2 | Experimental | Drug: UBT251Participants will receive UBT251 subcutaneously (SC). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (48 listed)
- 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:
- History or evidence of:
- Abnormal lab results:
- Participation in another interventional clinical trial within 3 months prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UBT251Administered SC | Drug | UBT251 Dose 1 |
| UBT251Administered SC | Drug | UBT251 Dose 2 |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Change from baseline in the Apnea-Hypopnea Index (AHI)
Time frame: Baseline, Week 52
8 secondary outcomes
Percentage change from baseline in AHI
Time frame: Baseline, Week 52
Percentage of participants with a reduction in AHI ≥ 50% from baseline
Time frame: Baseline, Week 52
Percentage of participants with an AHI < 5 events/hour or an AHI ≥ 5 and ≤ 14 events/hour with an Epworth Sleepiness Scale (ESS) score ≤ 10
Time frame: Baseline, Week 52
Percentage change from baseline in body weight
Time frame: Baseline, Week 52
Percentage of participants with a reduction in AHI ≥ 50% from baseline and a reduction in body weight ≥ 10% from baseline
Time frame: Baseline, Week 20, Week 52
Percentage change from baseline in the Sleep Apnea-Specific Hypoxia Burden (SASHB)
Time frame: Baseline, Week 20, Week 52
Change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a and PROMIS Sleep Disturbance Short Form 8b scores
Time frame: Baseline, Week 20, Week 52
Percentage of participants with improvement in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Time frame: Baseline, Week 20, Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing UBT251 in people with Obstructive Sleep Apnea, Obesity, run by The United Bio-Technology (Hengqin) Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linong Ji, MD (+8610-88325372, jiln@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Apnea-Hypopnea Index (AHI) (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.