A Non-interventional Study Investigating Semaglutide in Combination With Lifestyle-based Modifications for the Management of Obesity in Real-World Clinical Practice in Germany (WeGo Real Germany). (WeGoReal)

Novo Nordisk

Status: Invitation-only

Conditions: Obesity

Treatments: Drug: Semaglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT07081178

U1111-1314-8335 (Other Identifier)

NN9536-8332

Details and patient eligibility

About

Participants will be treated with commercially available semaglutide according to routine clinical practice at the discretion of the treating physician for the management of obesity. The purpose of this study is to collect data on the effect of Semaglutide under everyday conditions in participants. Participants and doctor had already decided that they will get semaglutide prescribed by doctor, independently of patient's participation in this study. The study will last for 12 months.

Enrollment: 555 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Common inclusion criteria for Group A and Group B:

1. Male or female, age above or equal to 18 years at the time signing informed consent.

2. Body mass index (BMI) more than or equal to (≥) 30 kilogram per meter square (kg/m^2) with at least one of the following diagnosed obesity-related comorbidities:

   arterial hypertension, pre-diabetes, Obstructive Sleep Apnea (OSA) or coronary heart disease, chronic heart failure, or BMI ≥35 kg/m^2.

3. History of at least one self-reported unsuccessful attempt to lose weight.

4. Capable of completing informed consent.

Additional inclusion criteria for Group A:

1. The decision to initiate treatment with commercially available Wegovy has been made by the participant and the treating physician before and independently from the decision to include the participant in this study.
2. Initiation of treatment is not modified in any case due to participant's participation in the study.

Common exclusion criteria for Group A and Group B:

1. Previous participation in this study (participation is defined as having given informed consent in this study)
2. Treatment with an investigational drug within 30 days prior to enrolment into the study.
3. Participant has had a prior serious allergic reaction to semaglutide or any of the ingredients in Wegovy.
4. Women with pregnancy or breast-feeding.
5. Women of childbearing potential and not using an adequate contraceptive method.
6. Men and women in their pregnancy attempts.
7. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
8. History of any Glucagon-like peptide-1 (GLP-1) treatment within 180 days.
9. History of type 1 or type 2 diabetes mellitus.

Trial design

555 participants in 2 patient groups

Group A

Description:

Participants will be treated with commercially available semaglutide along with lifestyle modification in the routine clinical practice.

Treatment:

Drug: Semaglutide

Group B

Description:

Participants with lifestyle modification in the routine clinical practice will be included.