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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04881760
Recruitment Status : Recruiting
First Posted : May 11, 2021
Last Update Posted : December 7, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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 may include up to 18 visits.

Condition or disease Intervention/treatment Phase
Obesity Overweight Drug: LY3437943 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 494 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities
Actual Study Start Date : May 20, 2021
Estimated Primary Completion Date : June 17, 2022
Estimated Study Completion Date : November 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3437943 Dose 1
LY3437943 administered subcutaneously (SC)
 Drug: LY3437943
Administered SC
Experimental: LY3437943 Dose 2
LY3437943 administered SC
 Drug: LY3437943
Administered SC
Experimental: LY3437943 Dose 3
LY3437943 administered SC
 Drug: LY3437943
Administered SC
Experimental: LY3437943 Dose 4
LY3437943 administered SC
 Drug: LY3437943
Administered SC
Placebo Comparator: Placebo
Placebo administered SC
 Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Mean Percent Change in Body Weight [ Time Frame: Randomization, Week 24 ]

Secondary Outcome Measures :
  1. Mean Percent Change in Body Weight [ Time Frame: Randomization, Week 48 ]
  2. Percentage of Participants Who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 24 ]
  3. Percentage of Participants Who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 48 ]
  4. Percentage of Participants Who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 24 ]
  5. Percentage of Participants Who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 48 ]
  6. Percentage of Participants Who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 24 ]
  7. Percentage of Participants Who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 48 ]
  8. Mean Change from Randomization in Body Weight [ Time Frame: Randomization, Week 24 ]
  9. Mean Change from Randomization in Body Weight [ Time Frame: Randomization, Week 48 ]
  10. Mean Change from Randomization in Body Mass Index (BMI) [ Time Frame: Randomization, Week 24 ]
  11. Mean Change from Randomization in BMI [ Time Frame: Randomization, Week 48 ]
  12. Mean Change from Randomization in Waist Circumference [ Time Frame: Randomization, Week 24 ]
  13. Mean Change from Randomization in Waist Circumference [ Time Frame: Randomization, Week 48 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04881760


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04881760    
Other Study ID Numbers: 18122
J1I-MC-GZBF ( Other Identifier: Eli Lilly and Company )
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Nutritional or Metabolism Disorder
Weight Loss
Overnutrition
 Incretins
Hormones
Physiological Effects of Drugs
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight