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NCT Number: NCT07414043

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

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

Recruiting

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Uberto Pagotto, MD

CONTACT

[email protected]

0512144190

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

    Time frame: 10 years

    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.

Secondary outcomes

  1. 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

    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, t-tests for paired data, Wilcoxon signed-rank tests, McNemar tests, t-tests, Kruskal-Wallis tests, chi-square tests, Fisher's exact tests, logistic regression models, conditional logistic regression, and linear mixed-effects models will be used to verify the secondary objectives.

    The p-value will be considered significant when less than 0.05 for two-tailed tests. Statistical analysis will be performed using IBM SPSS Statistics for Windows, Version 29.0 (Armonk, NY: IBM Corp) software.

  2. 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

  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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Uberto Pagotto, MD

CONTACT

[email protected]

0512144190

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

391/2025/OssF/AOUBo

Acronym: DrugsOb1

Important dates

Study start
2025
Primary completion
2036
Study completion
2036
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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