ACTIVE_NOT_RECRUITING

A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Study GZRA is a master protocol that will support 2 independent studies, GZ01 and GZ02. Participants will be assigned to the appropriate study prior to randomization. The purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe OSA and obesity or overweight. Study GZ01 will include participants who are unable or are unwilling to use PAP therapy. Study GZ02 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.

Official Title

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

Quick Facts

Study Start:2024-10-22

Study Completion:2027-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06649045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* have AHI ≥15 on PSG as part of the trial at screening (V1). * have body mass index (BMI) ≥27 kg/m² * Participants who are unable or unwilling to use PAP therapy. * Participants must not have used PAP for at least 4 weeks prior to screening. * 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.	* 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. * 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.

Inclusion Criteria

Exclusion Criteria

* have AHI ≥15 on PSG as part of the trial at screening (V1).
* have body mass index (BMI) ≥27 kg/m²
* Participants who are unable or unwilling to use PAP therapy.
* Participants must not have used PAP for at least 4 weeks prior to screening.
* 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.

* 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.
* 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.

Contacts and Locations

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

STUDY_DIRECTOR

Eli Lilly and Company

Study Locations (Sites)

Ark Clinical Research

Long Beach, California, 90815

United States

Peninsula Research Associates

Rolling Hills Estates, California, 90274

United States

Artemis Institute for Clinical Research

San Diego, California, 92103

United States

Care Access - Aurora

Aurora, Colorado, 80012

United States

EBGS Clinical Research Center

Snellville, Georgia, 30078

United States

Elite Clinical Trials

Blackfoot, Idaho, 83221

United States

Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative

Springfield, Illinois, 62711

United States

Care Access - Shreveport

Shreveport, Louisiana, 71105

United States

The Sleep Spot - Maimonides

Albuquerque, New Mexico, 87107

United States

Accellacare - Wilmington

Wilmington, North Carolina, 28401

United States

CTI Clinical Research Center

Cincinnati, Ohio, 45212

United States

Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)

Pittsburgh, Pennsylvania, 15236

United States

Preferred Primary Care Physicians

Uniontown, Pennsylvania, 15401

United States

FutureSearch Trials of Neurology

Austin, Texas, 78731

United States

Prime Revival Research Institute, LLC

Flower Mound, Texas, 75028

United States

Northwest Clinical Research Center

Bellevue, Washington, 98007

United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-22

Study Completion Date2027-01

Study Record Updates

Study Start Date2024-10-22

Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

OSA
Overweight or Obesity