A Placebo-Controlled Study to Investigate the Effect of investigational study medication on the Reduction of Morbidity and Mortality in Adults with Obesity

Last updated: November 29, 2023
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Cardiovascular Disease

Obesity

Treatment

N/A

Clinical Study ID

TX322046
I8F-MC-GPIJ
  • Ages 40-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

A Placebo-Controlled Study to Investigate the Effect of an investigational medication on the Reduction of Morbidity and Mortality in Adults with Obesity

Eligibility Criteria

Inclusion

Inclusion Criteria

In general, an individual may take part in the study if they

  • Have a BMI >27.0 kg/m2
  • Are either individuals 40 years of age with established cardiovascular disease >90 days prior to Visit 1, or women 55 years of age or men 50 years of age without established cardiovascular disease but have the presence of cardiovascular risk factors, such as current tobacco use, abnormal levels of fats (lipids) in the blood, high blood pressure, kidney disease, or elevated blood glucose levels.
  • Are reliable and willing to make themselves available for the duration of the study, attend required study visits, and are willing and able to follow study procedures as required.

In general, an individual may not take part in the study if they

  • Have a diagnosis or laboratory evidence of diabetes mellitus at screening
  • Have any of the following cardiovascular conditions within 90 days prior to screening
  • myocardial infarction (heart attack)
  • acute coronary syndrome
  • stroke
  • procedure to treat coronary artery disease, or
  • heart failure or signs or symptoms of heart failure requiring
  • IV medication, or
  •  a left ventricular assist device.
  • Have a planned procedure to treat coronary artery disease
  • Have uncontrolled high blood pressure
  • Have had or plan to have surgery or device treatment for obesity
  • Exception: Liposuction or abdominoplasty.
  • Use products intended for weight loss including prescription drugs, over-the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening

Study Design

Study Start date:
June 01, 2023
Estimated Completion Date:

Study Description

Study GPIJ is a Phase 3, international, randomized, double-blind, parallel group, event-driven study to investigate the reduction of morbidity and mortality with once weekly investigational study medication treatment compared to placebo in adult participants living with obesity and Cardio Vascular Disease risk. The study includes a

  • screening period
  • dose escalation treatment period, and
  • maintenance treatment period.

The dose escalation treatment period is the first 24 weeks of the study. The maintenance treatment period duration depends on when the specified number of endpoint events for the final analysis occurs. If the maintenance treatment period extends beyond 264 weeks (Visit 28), participants will continue extended maintenance visits (EMV) every 12 weeks until the study ends and the final visit occurs.

Connect with a study center

  • Elite Clinical Studies, LLC

    Phoenix, AZ 85018
    United States

    Active - Recruiting

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