Characterization and Phenotyping of Patients Who Are Offered Drug Therapy for Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Obesity & Overweight. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
391/2025/OssF/AOUBo
Overview
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
Detailed 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.
Primary outcome measures
- 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 [Time frame: 10 years]
Secondary outcome measures (3)
- 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 [Time frame: 10 years]
- descriptive statistics, paired t-tests, Wilcoxon signed-rank tests, McNemar tests, t-tests, Kruskal-Wallis tests, chi-square tests, Fisher's exact tests, logistic regression models, conditional logistic regression, linear mixed-effects models [Time frame: 10 years]
- 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 [Time frame: 10 years]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT07414043 · DrugsOb1