UBT251 Injection Phase Ⅲ Study (OSA-PAP)

NCT07806851 | Not Yet Recruiting Phase 3

• 1 other identifier: TUL-UBT251（III-5）202605
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

UBT251 will be compared with placebo (an inactive substance identical in appearance) to evaluate its therapeutic effect in participants with moderate-to-severe obstructive sleep apnea maintained on positive airway pressure therapy.Participants will complete the following study procedures:1. Receive once-weekly subcutaneous injections of either UBT251 or placebo for a total treatment period of 52 weeks, while remaining on stable positive airway pressure therapy;2. Undergo all examinations and tests within the visit windows specified in the trial protocol;3. Undergo assessment of the Apnea-Hypopnea Index (AHI) upon completion of the 52-week treatment period.

Conditions

Obstructive Sleep Apnea; Obesity

Keywords

obstructive sleep apnea; obesity; GLP-1; GIP; GCG

Outcome Measures

Primary Outcomes (1)

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

  Baseline, Week 52

Secondary Outcomes (9)

• Percentage change from baseline in the AHI

  Baseline, Week 52

• Proportion of participants with ≥50% reduction in Apnea-Hypopnea Index (AHI) from baseline

  Baseline, Week 52

• Percentage change from baseline in body weight

  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

  Baseline, Week 52

• Percentage of participants with a reduction in AHI ≥ 50% from baseline and a reduction in body weight ≥ 10% from baseline

  Baseline, Week 20, Week 52

Study Arms (3)

UBT251 Dose 1

EXPERIMENTAL

Participants will receive UBT251 subcutaneously (SC) .

Drug: UBT251

UBT251 Dose 2

EXPERIMENTAL

Participants will receive UBT251 subcutaneously (SC) .

Drug: UBT251

Placebo

PLACEBO COMPARATOR

Participants will receive placebo.

Drug: Placebo

Interventions

UBT251 DRUG

Administered SC

UBT251 Dose 1

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 have received stable positive airway pressure (PAP) therapy for at least 3 months prior to screening and who plan to continue PAP therapy throughout the study.
• 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.

You may not qualify if:

• 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 with the same target; 2) biguanides, SGLT-2 inhibitors, DPP-4 inhibitors, or any other hypoglycemic agents; 3) weight-influencing medications or anticipated use during the study (including systemic glucocorticoids \[excluding non-high-dose use \<7 days within 3 months prior to screening and planned use \<14 days during the study\], tricyclic antidepressants, antipsychotics, mood stabilizers); 4) over-the-counter weight-loss drugs or appetite suppressants (including traditional Chinese medicine, health supplements, meal replacements), prescription weight-loss drugs (e.g., orlistat), or lipolytic injections; 5) stimulants, sedative-hypnotics, opioids, trazodone, or muscle relaxants; 6) over-the-counter or prescription medications that may affect excessive daytime sleepiness assessment.
• History or evidence of any of the following diseases:
• Diagnosed with type 1, type 2 diabetes mellitus or other types of diabetes mellitus (history of gestational diabetes mellitus excluded);
• History of acute or chronic pancreatitis or pancreatic surgery;
• History of symptomatic gallbladder disease within 1 year prior to screening (excluding participants who underwent cholecystectomy completed at least 3 months before screening without long-term complications); or gallstones and/or bile duct stones detected by abdominal ultrasound at screening, assessed by the investigator to require treatment, likely to require treatment during the study, or other gallbladder lesions judged by the investigator to potentially compromise participant safety;
• Personal or family history (first-degree relatives: parents, children, siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
• Presence of endocrine disorders that may significantly affect body weight, e.g., Cushing's syndrome, pituitary-hypothalamic injury, hypogonadism; monogenic-obesity or hereditary obesity syndromes; obesity secondary to weight-loss medication reduction/discontinuation, long-term glucocorticoid, growth hormone or antipsychotic use;
• History of bariatric surgery or planned bariatric surgery, acupuncture weight-loss treatment, liposuction or abdominal lipolysis during the study, except for:a) Acupuncture weight-loss therapy or liposuction (e.g., abdominal liposuction) performed \>1 year prior to screening;b) Gastric band removed \>1 year prior to screening;c) Intragastric balloon removed \>1 year prior to screening;d) Duodenal-jejunal bypass sleeve removed \>1 year prior to screening;
• Previous history of depression, or Patient Health Questionnaire-9 (PHQ-9) score ≥15 at screening, or history of severe psychiatric disorders (including but not limited to suicidal ideation, schizophrenia, bipolar disorder);
• Positive response to suicidal ideation questions 4 or 5, or any suicidal-behavior-related questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening;
• History of clinically significant cardiovascular or cerebrovascular disease within 6 months prior to screening, defined as:a) Myocardial infarction (MI) or unstable angina;b) Cardiac-related surgery (including coronary artery bypass grafting, percutaneous coronary intervention);c) Congestive heart failure (New York Heart Association \[NYHA\] Class III-IV, see Appendix 2 for details);d) Cerebrovascular accident (old lacunar infarction excluded), including but not limited to hemorrhagic/ischemic stroke or transient ischemic attack;e) Other cardiovascular or cerebrovascular diseases assessed by the investigator that render the subject ineligible for the trial;
• Prior sleep-apnea-related surgery or major ENT surgery (including tonsillectomy, adenoidectomy), assessed by the investigator at screening to still influence the occurrence or severity of OSA; or planned sleep-apnea-related or major ENT surgery during the trial.
• Note: Participants with minor prior ENT surgery (e.g., septoplasty) may be considered eligible at the investigator's discretion.

Sponsors & Collaborators

• The United Bio-Technology (Hengqin) Co., Ltd.: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Haiyan Zhang

CONTACT

+86 18998165570; zhanghy@tul.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start (Estimated): October 10, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 8, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share