Semaglutide Effects on Sleep Apnea in Patients With Type 2 Diabetes/Obesity and Comorbid Obstructive Sleep Apnea

NCT07281196 | Completed FDA Drug

• 1 other identifier: 2025-KY-56-02
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Semaglutide (a GLP-1RA) is approved for type 2 diabetes mellitus T2DM and obesity, but its effect on obstructive sleep apnea OSA remains unclear. To evaluate changes in Apnea-Hypopnea Index (AHI) after 1-week and 4-week semaglutide treatment in T2DM/obesity patients with OSA, we conducted a single-center real-world study (RWS) of 15 patients. Outcomes assessed included AHI, weight, BMI, blood pressure, blood glucose (fasting blood glucose, glycated albumin), liver function, blood lipids, waist circumference, and other metabolic parameters, to provide real-world evidence for semaglutide in OSA management.

Conditions

Sleep Apnea Syndrome (OSAS)

Keywords

Semaglutide; Type 2 Diabetes; GLP-1 receptor agonist; real-world study; metabolic syndrome; AHI

Outcome Measures

Primary Outcomes (1)

• Changes in Apnea-Hypopea Index (AHI)

  Absolute change in AHI from baseline to 1 week after semaglutide treatment

  Baseline and 1 week

Secondary Outcomes (4)

• Changes in BMI

  Baseline, 1 week, 4 weeks

• Changes in weight

  Baseline, 1 week, 4 weeks

• Changes in waist circumference

  Baseline, 1 week, 4 weeks

• Changes in blood pressure

  Baseline, 1 week, 4 weeks

Other Outcomes (4)

• Changes in fasting glucose

  Baseline, 1 week, 4 weeks

• Changes in glycated albumin

  Baseline, 1 week, 4 weeks

• Changes in liver enzymes

  Baseline, 1 week, 4 weeks

Study Arms (1)

Semaglutide Treatment Group

single-arm cohort of 15 patients with T2DM/obesity and OSA receiving semaglutide (0.25-2.4mg/week) for 4 weeks

Drug: Semaglutide Subcutaneous Injection

Interventions

Semaglutide Subcutaneous Injection DRUG

This study is a observational study and the treatments are based on the clinical practice. In the study, patients with treatments were recorded. According to the instructions of drugs, 1ml of the injection contains 1.34mg of semaglutide. Each pre-filled injection pen contains 2mg of semaglutide and is placed in 1.5ml of solution. This product should be injected once a week.

Semaglutide Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

15 adults with T2DM/obesity and OSA receiving semaglutide

You may qualify if:

• \. Age 18-65 years. 2. BMI ≥27 kg/m²,with ≥1 comorbidity (hypertension, dyslipidemia, CVD) or T2DM. 3. On the basis of dietary control and exercise, the therapeutic effect is not satisfactory. There are indications for the use of semaglutide in clinical practice.
• \. Combined with obstructive sleep apnea syndrome. 5. Within the past month, no hormone drug treatment that affects glucose and lipid metabolism, nor any drugs such as antibiotics that significantly interfere with the oral flora, or bariatric surgery has been received.

You may not qualify if:

• Abnormal weight gain caused by endocrine diseases (pituitary/adrenal diseases, such as Cushing's syndrome; Or hypothyroidism, etc.)
• Severe renal/hepatic impairment (eGFR \<45 mL/min; ALT/AST \>2.5×ULN).
• Severe metabolic diseases, such as diabetic ketoacidosis and hyperosmolar hyperglycemic state, etc.
• Patients with type 1 diabetes or other special types of diabetes, patients with type 2 diabetes with severely impaired pancreatic islet function, or patients with type 2 diabetes who use insulin.
• There is a known history of drug use that affects glycolipid metabolism within three months, such as ① glucocorticoids; ② Fluoroquinolone antibiotics; ③ Beta-blockers such as metoprolol, etc. ④ Thyroid preparations such as thyroid hormone tablets; ⑤ Psychotropic drugs, including antipsychotic drugs such as chlorpromazine and olanzapine, as well as anti-anxiety or anti-depression drugs like SSRIS and NaSSAs; ⑥ SABA bronchodilators such as salbutamol and terbutaline; ⑦ Other known drugs that affect glycolipid metabolism, such as statins.
• Severe bleeding tendency, urinary and reproductive system infections; There are contraindications for the use of semaglutide, such as a history of acute or chronic pancreatitis, medullary thyroid carcinoma, and multiple endocrine neoplasia (MEN) type 2.
• Patients with contraindications to radiological examinations.
• Patients with advanced malignant tumors.
• Severe cardiovascular and cerebrovascular diseases, such as heart failure, etc.
• Rheumatic immune diseases, etc.
• Pregnant women and lactating women.
• Patients who have taken or are currently taking diuretics such as loop diuretics and thiazides within the past month.
• Currently involved in other interventional researchers.
• Other situations that the researchers consider unsuitable for the study, such as poor compliance, etc.

Sponsors & Collaborators

• Shanghai Fengxian District Central Hospital: lead

Study Sites (1)

Shanghai Fengxian District Central Hospital

Shanghai, 201499, China

Location

Related Links

• World Obesity Atlas 2024 \| World Obesity Federation\[EB/OL\]. \[2024-10-28\]

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Diabetes Mellitus, Type 2; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 15, 2025
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)