Status:
COMPLETED
A Study of LY3437943 in Participants Who Have Obesity or Are Overweight
Lead Sponsor:
Eli Lilly and Company
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Participants must have a Body Mass Index (BMI) ) ≥30 and ≤50 kilograms per square meter (kg/m²), or ≥27 kg/m² and \<30 kg/m², 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
- 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)
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2022
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT04881760
Start Date
May 20 2021
End Date
November 22 2022
Last Update
September 13 2023
Active Locations (28)
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1
Perseverance Research Center
Scottsdale, Arizona, United States, 85254
2
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
3
Valley Research
Fresno, California, United States, 93720
4
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States, 90255