Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients
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ClinicalTrials.gov Identifier: NCT02773355 |
Recruitment Status :
Enrolling by invitation
First Posted : May 16, 2016
Last Update Posted : July 24, 2020
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Condition or disease | Intervention/treatment |
---|---|
Obesity | Drug: liraglutide 3.0 mg |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients |
Actual Study Start Date : | May 16, 2016 |
Estimated Primary Completion Date : | January 29, 2021 |
Estimated Study Completion Date : | January 29, 2021 |

Group/Cohort | Intervention/treatment |
---|---|
Saxenda® |
Drug: liraglutide 3.0 mg
Patients will be treated with commercially available Saxenda® prescribed according to routine clinical practice at the discretion of the treating physician. |
- Frequency of pancreatitis [ Time Frame: Year 0-3 ]
- Adverse drug reactions (ADR) [ Time Frame: Year 0-3 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
- The decision to initiate treatment with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
- Obese patients (BMI equal to or above 30 kg/m^2) or overweight patients (BMI Equal to or above 27 kg/m^2) with at least one weight related comorbidity according to Saxenda® label text in Mexico
- Age equal or above 18 years at the time of signing informed consent
Exclusion Criteria:
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Hypersensitivity to Saxenda® or to any of its excipients
- Females of child-bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
- Diagnosis of type 1 diabetes

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773355
Mexico | |
Novo Nordisk Investigational Site | |
Mexico, Estado De México, Mexico, 52763 | |
Novo Nordisk Investigational Site | |
Monterrey, Nuevo León, Mexico, 66220 | |
Novo Nordisk Investigational Site | |
Puebla, Mexico, 72190 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT02773355 |
Other Study ID Numbers: |
NN8022-4210 U1111-1170-6497 ( Other Identifier: WHO ) |
First Posted: | May 16, 2016 Key Record Dates |
Last Update Posted: | July 24, 2020 |
Last Verified: | July 2020 |
Liraglutide Hypoglycemic Agents Physiological Effects of Drugs |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |