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

NCT07414043 | Recruiting

• 1 other identifier: DrugsOb1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity & Overweight

Outcome Measures

Primary Outcomes (1)

• 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

  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. 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. Descriptive statistics will be used to verify the primary objective. The demographic and clinical characteristics of patients will be reported as frequencies and percentages for categorical variables and as mean ± standard deviation or median and range for continuous variables.

  10 years

Secondary Outcomes (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

  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

  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

  10 years

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Uberto Pagotto, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uberto Pagotto, MD

CONTACT

0512144190; uberto.pagotto@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Head of Endocrinology, full professor

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: February 17, 2026
• Study Start: October 22, 2025
• Primary Completion (Estimated): June 30, 2036
• Study Completion (Estimated): June 30, 2036
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

IT (1)