Clinical trial • Phase III • Respiratory

orforglipron for Obstructive sleep apnea | Overweight or obesity

Phase III trial of orforglipron for Obstructive sleep apnea | Overweight or obesity.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Obstructive sleep apnea | Overweight or obesity
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
24-09-2024
First CTIS Authorization Date
14-01-2025

Trial design

Randomised, placebo to match ly (placebo arm). investigational product: orforglipron (sponsor product code ly3502970). dose and schedule not specified in the provided ctis data.-controlled Phase III trial across 12 sites in Czechia, Germany.

Randomised
Yes
Comparator
Placebo to match LY (placebo arm). Investigational product: orforglipron (sponsor product code LY3502970). Dose and schedule not specified in the provided CTIS data.
Target Sample Size
482
Trial Duration For Participant
364

Eligibility

Recruits 482 isVulnerablePopulationSelected = true is indicated in the CTIS record. Subject information and informed consent form documents are listed (e.g. L1_SIS and ICF_Main ICF, Patient Information Card), but the provided records do not include extractable text describing specific vulnerable group definitions or the consent/assent handling procedures (who provides consent, assent processes, or age-specific consent documents)..

Vulnerable Population
isVulnerablePopulationSelected = true is indicated in the CTIS record. Subject information and informed consent form documents are listed (e.g. L1_SIS and ICF_Main ICF, Patient Information Card), but the provided records do not include extractable text describing specific vulnerable group definitions or the consent/assent handling procedures (who provides consent, assent processes, or age-specific consent documents).

Inclusion criteria

  • {"criterion_text":"-(GZRA) Have AHI ≥15 on PSG as part of the trial at screening (V1)."}
  • {"criterion_text":"-(GZRA) Have body mass index (BMI) ≥27 kg/m²."}
  • {"criterion_text":"-(GZ01) Participants who are unable or unwilling to use PAP therapy."}
  • {"criterion_text":"-(GZ01) Participants must not have used PAP for at least 4 weeks prior to screening."}
  • {"criterion_text":"-(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

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

Endpoints

Primary endpoints

  • {"endpoint_text":"-Change from Baseline in Apnea-Hypopnea Index (AHI) [Time Frame: Baseline to Week 52]","definition_or_measurement_approach":"Change from baseline in AHI measured from Baseline to Week 52; AHI is assessed by polysomnography (PSG) (AHI ≥15 on PSG used in screening), primary endpoint time frame Baseline to Week 52."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
482
Recruitment Window Months
21
Consent Approach
Informed consent materials are listed (e.g. L1_SIS and ICF_Main ICF, Data Privacy Addendum, Patient Information Card). The CTIS record does not include extractable text of the consent/assent procedures; therefore the specifics (who provides consent, assent handling for minors, age-specific documents, or languages available) are not available from the provided files.

Methods

  • Posters (K2_Recruitment material_Poster and K2_Recruitment Material_Poster documents listed).
  • Letter to doctors / doctor referral letters (K2_Recruitment material_Letter Doctor Referral).
  • Site-based recruitment materials and planned site lists (K2_Recruitment material_List of planned sites, site-specific materials for Karlsruhe and Hannover).
  • Recruitment campaigns coordinated by commercial vendors (documents reference Clariness Recruitment Campaign, Trialbee, Clinical Trial Media and Clariness notes for EC).
  • Patient information materials and participant contact cards (Patient Information Card, Study Participant Contact Card).

Geography

Total Number Of Sites
12
Total Number Of Participants
118

Czechia

Earliest CTIS Part Ii Submission Date
17-01-2025
Latest Decision Or Authorization Date
07-04-2025
Processing Time Days
80
Number Of Sites
3
Number Of Participants
44

Sites

Site Name
Milan Kvapil s.r.o.
Contact Person Name
Klaudia Hálová Karoliová
Contact Person Email
klaudiehk@seznam.cz
Site Name
Nemocnice Rudolfa a Stefanie Benesov a.s. nemocnice Stredoceskeho kraje
Department Name
Otorhinolaryngology
Contact Person Name
Hana Haasová
Contact Person Email
Tereza.Haasova@hospital-bn.cz
Site Name
Praglandia s.r.o.
Contact Person Name
Zuzana Foglarová
Contact Person Email
z.foglar@praglandia.cz

Germany

Earliest CTIS Part Ii Submission Date
02-12-2024
Latest Decision Or Authorization Date
26-06-2025
Processing Time Days
206
Number Of Sites
9
Number Of Participants
74

Sites

Site Name
Siteworks GmbH
Contact Person Name
Ulrike Lengler
Contact Person Email
lengler@siteworks-research.de
Site Name
Uhz Klinische Forschung
Contact Person Name
Dirk Weber
Contact Person Email
dirk-weber@uhz-klifo.de
Site Name
InnoDiab Forschung GmbH
Contact Person Name
Thomas Schürholz
Contact Person Email
thomas.schuerholz@innodiab.de
Site Name
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
Contact Person Name
Thomas Schaum
Contact Person Email
schaum@red-institut.de
Site Name
Siteworks GmbH (Karlsruhe site)
Contact Person Name
Julia Chevts
Contact Person Email
chevts@siteworks-research.de
Site Name
CIMS Studienzentrum Bamberg GmbH
Contact Person Name
Johannes Haas
Contact Person Email
dr.haas@besser-luft.de
Site Name
Advanced Sleep Research GmbH
Contact Person Name
Katharina Lederer
Site Name
Institut fuer Diabetesforschung Muenster GmbH
Contact Person Name
Ludger Rose
Contact Person Email
l.rose@diabetes-muenster.de
Site Name
Siteworks GmbH (Essen/Karlsruhe/other listed locations)

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
sponsorDuties codes: [11]; contact: melissa.meyerely@syneoshealth.com
Name
Iqvia Inc.
Responsibilities
sponsorDuties codes: [1]; contact: els.vannylen@iqvia.com
Name
Pharmaceutical Product Development LLC
Responsibilities
sponsorDuties codes: [4]; contact: kathy.dick@ppdi.com
Name
Q2 Solutions LLC
Responsibilities
sponsorDuties codes: [4]; contact: robin.bushnell@Q2LabSolutions.com
Name
Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.
Responsibilities
sponsorDuties codes: [4]; contact: Lili.Zheng@labcorp.com

Third parties

  • {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"sponsorDuties codes: [13]; contact email: brownk@ccf.org","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties codes: [2]; contact email: christian.keeney@greenphire.com","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Sweden","full_name":"Trialbee AB","duties_or_roles":"sponsorDuties codes: [2]; contact email: lucie.green@trialbee.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"sponsorDuties codes: [7]; contact email: compliance@clinicalink.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties codes: [4]; contact email: robin.bushnell@Q2LabSolutions.com","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: [11]; contact email: melissa.meyerely@syneoshealth.com","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"sponsorDuties codes: [2]; contact email: george.doresett@clariness.com","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"sponsorDuties codes: [1]; contact email: els.vannylen@iqvia.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties codes: [7]; contact email: jacques.mourrain@veeva.com","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties codes: [15] (Translations); contact email: Shawn.McKown@rws.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"sponsorDuties codes: [2]; contact email: hshinn@clinicaltrialmedia.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"IQVIA Connected Devices","duties_or_roles":"sponsorDuties codes: [4]; contact email: els.vannylen@iqvia.com","organisation_type":"Health care"}
  • {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"sponsorDuties codes: [4]; contact email: Lili.Zheng@labcorp.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: [4]; contact email: kathy.dick@ppdi.com","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Orforglipron (sponsor product code LY3502970)
Active Substance
orforglipron
Modality
Small molecule
Routes Of Administration
Oral use
Route
ORAL USE
Authorisation Status
Investigational (non-authorised for the indication being studied)

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