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Active, Not Recruiting

NCT Number: NCT06649045

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

OSA Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight or Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Orforglipron

Drug

Administered orally.

Other names: LY3502970

Placebo

Drug

Administered orally.

Primary outcomes

  1. Change from Baseline in Apnea-Hypopnea Index (AHI)

    Time frame: Baseline to Week 52

Secondary outcomes

  1. Percent Change from Baseline in AHI

    Time frame: Baseline to Week 52

  2. Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% min/hour)

    Time frame: Baseline to Week 52

  3. Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-score

    Time frame: Baseline to Week 52

  4. Percentage of Participants Achieving ≥50% AHI Reduction

    Time frame: Baseline to Week 52

  5. Percent of Participants with AHI<5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10

    Time frame: Baseline to Week 52

  6. Percent Change from Baseline in Body Weight

    Time frame: Baseline to Week 52

  7. Change from Baseline in high-sensitivity C reactive protein (hsCRP) Concentration

    Time frame: Baseline to Week 52

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: ATTAIN-OSA

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 18, 2024
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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