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Clinical Trial for Severe Obesity and Established Cardiovascular Disease (104 Weeks)


Age: 18 Years


Adults aged 18 years or older with a clinical diagnosis of Severe Obesity and Established Cardiovascular Disease, may be eligible for a 104-week research trial. Inclusion criteria include being adults aged ≥ 18 years of age, have a BMI ≥35 kg/m2 at screening, and have a a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.

Participants will receive a treatment via a Subcutaneous Injection (SC).  Study treatment and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.

Study participation will last about 11-12 months and involve about 8 visits to the study centre


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Michael Hartleib

Cardiologist

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The following information is from ClinicalTrials.gov

Last Update Posted: April 07, 2024

Official Title

A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants With Severe Obesity and Established Cardiovascular Disease

ClinicalTrials.gov ID

NCT05882045

Sponsor

Eli Lilly and Company

Study Description

  • Brief Summary:

    The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 weeks.

  • Condition or Disease:

    Obesity

  • Intervention/Treatment:

    Drug: Retatrutide
    Drug: Retatrutide
    Drug: Placebo
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²).

Have established cardiovascular (CV) disease with at least 1 of the following:

prior myocardial infarction
prior ischemic or hemorrhagic stroke, or
symptomatic peripheral arterial disease
Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.

Exclusion Criteria:

Have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening.
Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
Have a prior or planned surgical treatment of obesity.
Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening.
Have Type 1 diabetes.
Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Have had pancreatitis.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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Obesity

Adults aged 45 and older who have a body mass index (BMI) of 27 kg/m2 or more, may qualify to participate in this... Learn More
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