Characterization and Phenotyping of Patients Who Are Offered Drug Therapy for Obesity (DrugsOb1)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Obesity & Overweight

Study type: Observational

Funder types: Other

Identifiers

NCT07414043

DrugsOb1

Details and patient eligibility

About

The study is multicenter and observational, consisting of a cross-sectional phase (V0) in which data will be collected from patients who are offered drug therapy, and a prospective longitudinal phase in which only patients who agree to start drug therapy for obesity will be involved

Full description

The primary objective is to identify the proportion and medical history, social, clinical, laboratory, and behavioral characteristics of patients who accept a prescription for a drug for overweight and obesity compared to the total number of patients to whom it is proposed.

The secondary objective will only concern patients who decide to start anti-obesity drug therapy. In this population, the efficacy and tolerance of these molecules and patient adherence to drug therapy in a real-life setting will be evaluated.

These parameters will be monitored with regular follow-ups for up to 5 years after the start of therapy or 12 months after discontinuation of the drug.

The study population will consist of patients aged ≥ 12 years, the age at which certain therapies are approved for obesity (Liraglutide and Semaglutide in particular).

Patients will be recruited from among those who meet all inclusion and exclusion criteria and are followed up at the listed healthcare units or by the listed private practitioners.

Enrollment: 500 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Age ≥ 12 years

• Therapeutic indication for taking one of the following drugs for the treatment of obesity: Orlistat, Naltrexone/Bupropion (Mysimba®), Liraglutide (Saxenda®), Semaglutide (Wegovy®), Tirzepatide (Mounjaro®)

Exclusion Criteria: - Type 1 and type 2 diabetes mellitus

- Secondary forms of obesity:

• Hypothalamic obesity (both monogenic and acquired forms);
• Syndromic obesity (e.g., Prader-Willi, Alstrom, Bardet Biedl, etc.);
• Endocrinopathies associated with obesity (Cushing's syndrome, uncompensated hypothyroidism)