A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight (ATTAIN-OSA)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eli Lilly & Co.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

29 Jan 2025 → ongoing

Decision date (initial)

2025-01-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-515905-25-00

WHO UTN

U1111-1312-2572

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

To demonstrate that orforglipron is superior to placebo for change in Apnea-Hypopnea Index (AHI).

Conditions and MedDRA coding

Overweight or Obesity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. (GZRA) Have AHI ≥15 on PSG as part of the trial at screening (V1).
2. (GZRA) Have body mass index (BMI) ≥27 kg/m².
3. (GZ01) Participants who are unable or unwilling to use PAP therapy.
4. (GZ01) Participants must not have used PAP for at least 4 weeks prior to screening.
5. (GZ02) 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 13

1. (GZRA) Have Type 1 diabetes (T1D) or Type 2 diabetes (T2D), history of ketoacidosis, or hyperosmolar state/coma.
2. (GZRA) Have HbA1c ≥6.5% (≥ 48 mmol/mol), as determined by the central laboratory at Visit 1.
3. (GZRA) Had any previous or planned upper airway surgery for sleep apnea or major ear, nose or throat surgery.
4. (GZRA) Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration.
5. (GZRA) Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
6. (GZRA) Active device treatment of OSA other than PAP therapy.
7. (GZRA) Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
8. (GZRA) Have a self-reported change in body weight >5 kg within 3 months prior to screening.
9. (GZRA) Have a prior or planned surgical treatment for obesity (excluding liposuction, abdominoplasty or cryolipolysis if performed more than 1 year prior to screening).
10. (GZRA) Have a prior or planned endoscopic and/or present device-based therapy for obesity.
11. (GZRA) Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
12. (GZ02) 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.
13. (GZ02) Are unwilling to temporary discontinue PAP therapy for 7 days prior to PSG testing during the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

Sponsor organisation

Eli Lilly & Co.

Address

1 Lilly Corporate Center

City

Indianapolis

Postcode

46285-0001

Country

United States

Scientific contact point

Organisation

Eli Lilly & Co.

Contact name

Lilly Clinical Trials information desk

Public contact point

Organisation

Eli Lilly & Co.

Contact name

Lilly Clinical Trials information desk

Third parties 14

Locations

2 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 33 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications