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A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obstructive Sleep Apnea and Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (J5P-MC-GZRA)

A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight (J5P-MC-GZRA)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Not Recruiting

Jan. 07, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Master GZRA inclusion criteria
- have AHI >=15 on PSG as part of the trial at screening (V1).
- have body mass index (BMI) >=27 kg/m2
Study 1 GZ01 inclusion 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.
Study 2 GZ02 inclusion criteria
- Participants who have been on PAP therapy for at least 3 consecutive months prior to study start and plan to continue PAP therapy during the study.

Master GZRA exclusion criteria
- Have Type 1 diabetes (T1D) or Type 2 diabetes (T2D), history of ketoacidosis, or hyperosmolar state/coma
- Have HbA1c >=6.5% (>= 48 mmol/mol), as determined by the central laboratory at Visit 1.
- Had any previous or planned upper airway surgery for sleep apnea or major ear, nose or throat surgery
- 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
- 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, abdominoplasty or cryolipolysis if performed more than 1 year prior to screening)
- Have a prior or planned endoscopic and/or present device-based therapy for obesity.
- Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
Study 2 GZ02 exclusion criteria
- Have personal or job-related responsibilities, or in the opinion of the investigator have any situation that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the study.
- Are unwilling to temporary discontinue PAP therapy for 7 days prior to PSG testing during the study.

Both

OSA
Overweight or Obesity

DRUG: Orforglipron(Other Name: LY3502970)
Administered orally.
DRUG: Placebo
Administered orally.

[Study Arms]
Experimental: Orforglipron
Participants will receive orforglipron orally.

Study 1 GZ01: Participants who are unable or unwilling to use PAP

Study 2 GZ02: Participants who plan to continue PAP therapy
Interventions:
Drug: Orforglipron
Placebo Comparator: Placebo
Participants will receive placebo orally.

Study 1 GZ01: Participants who are unable or unwilling to use PAP

Study 2 GZ02: Participants who plan to continue PAP therapy
Interventions:
Drug: Placebo

Change from Baseline in Apnea-Hypopnea Index (AHI) [ Time Frame: Baseline to Week 52

+81-42-648-5551

Oct. 18, 2024

Yes

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

United States