ObStructive Sleep Apnoea ManageMent in Older AdUlts with Overweight or ObEsity: A Randomized ClinicaL Trial (SAMUEL study)

2026-525500-10-00 · tracked via the Priya Life Science EU tracker

Sponsor

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

Sponsor type

Laboratory/Research/Testing facility

Therapeutic area

Nutritional and Metabolic Diseases

Decision date

29/06/2026

Enrollment target

345

Sites

Spain

Condition studied

Obstructive sleep apnea syndrome, Obesity

Investigational medicinal product(s)

Mounjaro 10 mg solution for injection in vial

Eligibility

Age group

65+ years

Sex

Female, Male

Primary endpoint

Change from baseline in the Apnea-Hypopnea Index (AHI) at week 24.

Endpoint detail

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.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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