Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
345
Countries
1
Sites
2
Obstructive sleep apnea syndrome
To determine the best first-line treatment for Obstructive Sleep Apnea (OSA) in older adults (≥65 years) with overweight or obesity by comparing the efficacy of Tirzepatide versus Continuous Positive Airway Pressure (CPAP) and versus an interdisciplinary lifestyle modification intervention, based on the change in the A…
Key facts
- Sponsor
- Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2026-06-29
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
To determine the best first-line treatment for Obstructive Sleep Apnea (OSA) in older adults (≥65 years) with overweight or obesity by comparing the efficacy of Tirzepatide versus Continuous Positive Airway Pressure (CPAP) and versus an interdisciplinary lifestyle modification intervention, based on the change in the Apnea-Hypopnea Index (AHI) after 24 weeks of treatment.
Secondary objectives 6
- To evaluate the impact of the different interventions on sleep quality and daytime sleepiness.
- To assess the changes in body weight and body composition across the study arms.
- To determine the effect of the interventions on blood pressure and heart rate.
- To evaluate the impact on cognitive function and quality of life in the elderly population.
- To compare the safety and tolerability profile of Tirzepatide versus CPAP and lifestyle interventions in adults aged 65 and over.
- To analyze the cost-effectiveness of each treatment strategy for the management of OSA in this population.
Conditions and MedDRA coding
Obstructive sleep apnea syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10040977 | Sleep apnoea | 10038738 |
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment Period 24-week active intervention phase following the baseline screening and randomization.
|
Randomised Controlled | None | Experimental Arm: Tirzepatide (Mounjaro).: Participants in this arm will receive Tirzepatide (Mounjaro) administered once weekly via subcutaneous injection. The treatment follows a dose-escalation schedule starting at 2.5 mg/week, increasing by 2.5 mg every 4 weeks until reaching the maintenance dose of 10 mg/week by week 13. This dose will be maintained until the end of the 24-week intervention period to evaluate its efficacy on Obstructive Sleep Apnea (OSA) severity and weight reduction. Active Comparator: CPAP therapy.: Participants in this arm will receive standard-of-care treatment for Obstructive Sleep Apnea (OSA) using a Continuous Positive Airway Pressure (CPAP) device. The therapy will be adjusted according to clinical guidelines and monitored for adherence and efficacy throughout the 24-week study period. Active Comparator: Lifestyle Intervention: Participants in this arm will follow a structured lifestyle modification program focused on intensive weight loss. This includes a personalized hypocaloric diet (prescribed by a nutritionist) and a supervised physical activity plan, aiming for a reduction in Body Mass Index (BMI) to improve OSA symptoms without pharmacological or mechanical intervention. |
|
| 2 | Recruitment Period Potential participants will undergo clinical evaluation, polysomnography, and laboratory tests to verify eligibility criteria before randomization.
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age >= 65 years.
- Clinical diagnosis of moderate-to-severe Obstructive Sleep Apnea (OSA) defined by an Apnea-Hypopnea Index (AHI) >= 15 events/h.
- Body Mass Index (BMI) >= 27 kg/m2
- Patients who are candidates for CPAP therapy or lifestyle intervention.
- Capable of giving signed informed consent.
Exclusion criteria 7
- Previous use of GLP-1 receptor agonists or GIP/GLP-1 receptor agonists within 3 months prior to screening.
- Diagnosis of Type 1 Diabetes Mellitus.
- History of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- History of chronic pancreatitis.
- Severe renal impairment (eGFR <30mL/min/1.73m2)
- Major cardiovascular event (infarction, stroke) within the last 6 months.
- Any condition that, in the investigator's opinion, prevents the patient from completing the study procedures (e.g., severe cognitive impairment).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from baseline in the Apnea-Hypopnea Index (AHI) at week 24.
Secondary endpoints 4
- Change from baseline in the Epworth Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index (PSQI) at week 24.
- Change from baseline in body weight (kg) and Body Mass Index (BMI) at week 24.
- Change from baseline in the Montreal Cognitive Assessment (MoCA) score at week 24.
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the 24-week period.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Mounjaro 10 mg solution for injection in vial
PRD10888340 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-L-.ALPHA.-GLUTAMYLGLYCYL-L-THREONYL-L-PHENYLALANYL-L-THREONYL-L-SERYL-L- .ALPHA.-ASPARTYL-L-TYROSYL-L-SERYL-L-ISOLEUCYL-2-METHYLALANYL-L-LEUCYL-L-.ALPHA.-ASPARTYL-L-LYSYL-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 1.43 mg milligram(s)
- Max total dose
- 212.5 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/022
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Sponsor organisation
- Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Address
- Avinguda De L'Alcalde Rovira Roure 80
- City
- Lleida
- Postcode
- 25196
- Country
- Spain
Scientific contact point
- Organisation
- Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Contact name
- Adriano Targa Dias Santos
Public contact point
- Organisation
- Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
- Contact name
- Adriano Targa Dias Santos
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 345 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitari De Santa Maria
Pulmonology, Av Alcalde Rovira Roure 44, 25198, Lleida
Hospital Universitario De Guadalajara SESCAM
Pulmonology, Calle De Los Donantes De Sangre S/n, 19002, Guadalajara
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2026-525500-10-00_public | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults_public | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Mounjaro | 1 |
| Synopsis of the protocol (for publication) | D1_Protocolsynopsis_2026-525500-10-00_ENG | 1 |
| Synopsis of the protocol (for publication) | D1_Protocolsynopsis_2026-525500-10-00_ESP | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-08 | Spain | Acceptable 2026-06-25
|
2026-06-29 |