The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI-1

JRCT ID: jRCT2031220154

Registered date:22/06/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Sleep Apnea,Obesity
• Date of first enrollment: 25/10/2022
• Target sample size: 206
• Countries of recruitment: Australia,Japan,Brazil,Japan,China,Japan,Czech Republic,Japan,Germany,Japan,Mexico,Japan,United States,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

-Experimental: Tirzepatide Maximum Tolerated Dose
Participants will receive a low dose and then increase to a maximum tolerated dose 1 or dose 2 subcutaneously (SC).
-Placebo Comparator: Placebo
Participants will receive placebo SC

Outcome(s)

• Primary Outcome: Percent Change from Baseline in Apnea-Hypopnea Index (AHI) [ Time Frame: Baseline, Week 52 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Participants who are unable or unwilling to use PAP therapy. Participants must not have used PAP for at least 4 weeks prior to screening.
- Have an AHI >=15 on PSG as part of the trial at screening
- Have a body mass index (BMI) >=30 kilogram/square meter (kg/m2)
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight

Exclude criteria

-Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed.
-Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma.
-Have HbA1c >= 6.5% (>= 48 mmol/mol) at baseline
-Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of baseline
-Have significant craniofacial abnormalities that may affect breathing at baseline
-Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas >=50%, or diagnosis of Cheyne Stokes Respiration
-Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
-Active device treatment of OSA other than PAP therapy (for example, dental appliance), or other treatment, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at baseline and throughout the study.
-Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
-Have a self-reported change in body weight >5 kg within 3 months prior to screening
-Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed more than 1 year prior to screening)
-Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months (for example, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal bypass sleeve)

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05412004