AzTrials
AzTrials

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..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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;
Show all 48Show fewer
  • 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.

Linong Ji, MD contact

+8610-88325372

jiln@bjmu.edu.cn

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

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 groups in NCT07767942
Study groupRoleWhat they receive
UBT251 Dose 1ExperimentalParticipants will receive UBT251 subcutaneously (SC).
Receives: Drug: UBT251
UBT251 Dose 2ExperimentalParticipants will receive UBT251 subcutaneously (SC).
Receives: Drug: UBT251
PlaceboPlacebo comparatorParticipants will receive placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the Apnea-Hypopnea Index (AHI)

    Measured: Baseline, Week 52

Secondary outcomes (8)

  1. Percentage change from baseline in AHI

    Measured: Baseline, Week 52

  2. Percentage of participants with a reduction in AHI ≥ 50% from baseline

    Measured: Baseline, Week 52

  3. 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

  4. Percentage change from baseline in body weight

    Measured: Baseline, Week 52

  5. 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

  6. Percentage change from baseline in the Sleep Apnea-Specific Hypoxia Burden (SASHB)

    Measured: Baseline, Week 20, Week 52

  7. 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

  8. 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.

  1. First posted17 Aug 2026
  2. Study start18 Sep 2026 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT07767942.

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; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in