Actively Recruiting
Characterization and Phenotyping of Patients Offered Drug Therapy for Obesity Observational Study Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-02-17
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand patients who are offered drug treatments for obesity, focusing on their medical history, social, clinical, laboratory, and behavioral characteristics. The study includes participants aged 12 and older and observes those who accept anti-obesity drug prescriptions compared to all patients offered such therapy. The study has two phases: a cross-sectional phase where data is collected from patients offered drug therapy, and a prospective longitudinal phase involving patients who agree to start drug treatment. The drugs studied include Orlistat, Naltrexone/Bupropion, Liraglutide, Semaglutide, and Tirzepatide. Participants will be followed for up to five years after starting therapy or for 12 months after stopping the medication. Throughout the study, participants will undergo regular follow-ups to monitor drug effectiveness, tolerance, and adherence in real-life settings. Researchers will collect various data, including medical, social, and behavioral information, and use statistical analyses to evaluate outcomes. The total participation time can last up to ten years, covering both treatment and post-treatment periods.
CONDITIONS
Brief Title
Characterization and Phenotyping of Patients Who Are Offered Drug Therapy for Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older
- Have a therapeutic indication for one of these drugs for obesity treatment: Orlistat, Naltrexone/Bupropion (Mysimba�), Liraglutide (Saxenda�), Semaglutide (Wegovy�), Tirzepatide (Mounjaro�)
- Be followed at participating healthcare units or by listed private practitioners
You will not qualify if you...
- Have type 1 or type 2 diabetes mellitus
- Have secondary forms of obesity such as hypothalamic obesity (monogenic or acquired)
- Have syndromic obesity, for example, Prader-Willi, Alstrom, or Bardet Biedl syndromes
- Have endocrinopathies linked to obesity such as Cushing's syndrome or uncompensated hypothyroidism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants who accept a prescription for anti-obesity drug therapy are monitored for efficacy, tolerance, and adherence to therapy in a real-life setting.
Regular follow-ups for up to 5 years after the start of therapy or 12 months after discontinuation of the drug
Duration - Up to 10 years
Participants are observed to evaluate long-term medical history, social, clinical, laboratory, and behavioral characteristics related to obesity and drug therapy.
Ongoing assessments during study period
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
U
Uberto Pagotto, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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