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OpenTrials
Completed

NCT Number: NCT02773355

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro de Investigacion Clinica Endocrinologica de Jalisco, Guadalajara, Jalisco, Mexico

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

liraglutide 3.0 mg

Drug

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

Primary outcomes

  1. Frequency of pancreatitis

    Time frame: Year 0-3

Secondary outcomes

  1. Adverse drug reactions (ADR)

    Time frame: Year 0-3

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
May 16, 2016
Registry last updated
Apr 13, 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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