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Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients

Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02773355
Enrollment
27
Registered
2016-05-16
Start date
2016-05-16
Completion date
2022-02-28
Last updated
2022-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

This trial is conducted in North America. The aim is to investigate timely detection of pancreatitis cases as well as cases of suspicion of serious and non-serious adverse reactions possibly or probably related to Saxenda® in Mexican patients.

Interventions

Patients will be treated with commercially available Saxenda® prescribed according to routine clinical practice at the discretion of the treating physician.

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 the 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

Design outcomes

Primary

MeasureTime frame
Frequency of pancreatitisYear 0-3

Secondary

MeasureTime frame
Adverse drug reactions (ADR)Year 0-3

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026