A Study of LY3437943 in Participants Who Have Obesity or Are Overweight

  • STATUS
    Recruiting
  • End date
    Sep 28, 2022
  • participants needed
    300
  • sponsor
    Eli Lilly and Company
Updated on 12 September 2021
cardiovascular disease
body mass index
hypertension
dyslipidemia

Summary

This is a study of LY3437943 in participants who have obesity or are overweight. The main purpose is to learn more about how LY3437943 affects body weight loss. The study will last about 18 months and may include up to 18 visits.

Details
Condition adiposity, Overweight, Obesity
Treatment Placebo, LY3437943
Clinical Study IdentifierNCT04881760
SponsorEli Lilly and Company
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must have a Body Mass Index (BMI) ) 30 and 50 kilograms per square meter (kg/m), or 27 kg/m and <30 kg/m, with at least one of the following comorbidities: hypertension, dyslipidemia, cardiovascular disease
Participants must be willing to learn how to self-inject study drug or receive an injection from a trained individual if visually impaired or with physical limitations, and follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice (for example, dietary changes and physical activity plan), maintain a study drug administration log, and complete required questionnaires

Exclusion Criteria

Participants must not have type 1 or type 2 diabetes mellitus
Participants must not have had an increase or decrease in body weight > more than 5 kg (11 pounds) within the past 3 months
Participants must not have had surgery for obesity or plan to have such surgery during the study
Participants must not be using medications that promote weight loss or cause weight gain
Participants must not drink excessive amounts of alcohol (more than 14 units a week for women or more than 21 units a week for men)
Participants must not have used marijuana within the last 3 months
Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months
Participants must not have active cancer within the last 5 years
Participants must not have uncontrolled high blood pressure
Participants must not have liver disease other than non-alcoholic fatty liver disease
Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2
Participants must not have a history of acute or chronic pancreatitis symptomatic gallbladder disease or documented human immunodeficiency virus infection
Participants must not have a major problem with depression or other mental illness within the last 2 years
Participants must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative)
Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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