A Study of LY3437943 in Participants Who Have Obesity or Are Overweight
NCT ID: NCT04881760
Last Updated: 2023-09-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
338 participants
INTERVENTIONAL
2021-05-20
2022-11-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants received placebo matched to LY3437943 administered as subcutaneous (SC) injection once-weekly (QW).
Placebo
Administered SC
1 milligram (mg) LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
LY3437943
Administered SC
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
LY3437943
Administered SC
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
LY3437943
Administered SC
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
LY3437943
Administered SC
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
LY3437943
Administered SC
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
LY3437943
Administered SC
Interventions
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LY3437943
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Perseverance Research Center
Scottsdale, Arizona, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Valley Research
Fresno, California, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
Velocity Clinical Research, Huntington Park
Los Angeles, California, United States
Southern California Dermatology, Inc.
Santa Ana, California, United States
Coastal Metabolic Research Centre
Ventura, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Encore Medical Research - Weston
Weston, Florida, United States
Springfield Diabetes & Endocrine Center
Springfield, Illinois, United States
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, United States
Tandem Clinical Research,LLC
Marrero, Louisiana, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Amici Clinical Research LLC
Raritan, New Jersey, United States
Intend Research, LLC
Norman, Oklahoma, United States
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, United States
New Phase Research and Development
Knoxville, Tennessee, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Juno Research
Houston, Texas, United States
Endocrine Ips, Pllc
Houston, Texas, United States
Southern Endocrinology Associates
Mesquite, Texas, United States
Rainier Clinical Research Center
Renton, Washington, United States
Private Practice - Dr. Paola Mansilla-Letelier
Guaynabo, , Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, , Puerto Rico
San Juan City Hospital
San Juan, , Puerto Rico
Countries
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References
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Sanyal AJ, Kaplan LM, Frias JP, Brouwers B, Wu Q, Thomas MK, Harris C, Schloot NC, Du Y, Mather KJ, Haupt A, Hartman ML. Triple hormone receptor agonist retatrutide for metabolic dysfunction-associated steatotic liver disease: a randomized phase 2a trial. Nat Med. 2024 Jul;30(7):2037-2048. doi: 10.1038/s41591-024-03018-2. Epub 2024 Jun 10.
Jastreboff AM, Kaplan LM, Frias JP, Wu Q, Du Y, Gurbuz S, Coskun T, Haupt A, Milicevic Z, Hartman ML; Retatrutide Phase 2 Obesity Trial Investigators. Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial. N Engl J Med. 2023 Aug 10;389(6):514-526. doi: 10.1056/NEJMoa2301972. Epub 2023 Jun 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3437943 in Participants Who Have Obesity or Are Overweight
Other Identifiers
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J1I-MC-GZBF
Identifier Type: OTHER
Identifier Source: secondary_id
18122
Identifier Type: -
Identifier Source: org_study_id
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