ExplorEUEast: A Study to Understand the Distribution of Obesity Classes and Obesity Related Diseases in People With Obesity Across Countries in Czech Republic, Hungary and Poland

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05795166
• Collaborator: (none)
• Enrollment: 1,200
• Locations: 3
• Anticipated Duration (Months): 7
• Patients Per Site: 400
• Patients Per Site Per Month: 56.9

Study Details

Study Description

Brief Summary

The study is intended to understand the distribution of different obesity classes and obesity related diseases (diseases that present along with obesity) in patients with body mass index (BMI) ≥ 30 kg/m^2.

Participants will be asked to give information about their health. They will continue their normal way of life and will not get any medication or additional medical test other than those prescribed to you by their doctor. Participation in the study will last for about 1 day.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: No treatment given

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1200 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: A Multicentre, Observational Study to Understand the Distribution of Obesity Classes and Obesity Related Comorbidities (ORCs) in People With Obesity Within a Real World Population in Czech Republic, Hungary and Poland
• Anticipated Study Start Date: Apr 30, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
People with obesity Patients with obesity coming into the clinic as part of routine visit to their treating physician/general practitioner	Other: No treatment given; No treatment given

Outcome Measures

Primary Outcome Measures

1. Percentage of patients with at least one obesity related comorbidity of interest for obesity classes I, II and III pooled across all countries [At the time of enrolment (Day 1)]

   % patients with obesity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

1. Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).

2. Male or female, age greater than or equal to 18 years at the time of inclusion/enrolment in the study.

3. BMI greater than or equal to 30 Kg/m^2 as measured at the inclusion in the study

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study.

2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation as judged by physician.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Praha		Czechia
2	Novo Nordisk Investigational Site	Budapest		Hungary
3	Novo Nordisk Investigational Site	Warszawa		Poland

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT05795166
• Other Study ID Numbers: DAS-7530; U1111-1277-8275
• First Posted: Apr 3, 2023
• Last Update Posted: Apr 3, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Apr 3, 2023