A Study of LY3437943 in Participants With Type 2 Diabetes
NCT ID: NCT04867785
Last Updated: 2023-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
281 participants
INTERVENTIONAL
2021-05-13
2022-10-27
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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0.5 milligrams (mg) LY3437943
Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (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 (4 mg)
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 a SC injection QW.
LY3437943
Administered SC
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as a SC injection QW.
LY3437943
Administered SC
1.5 mg Dulaglutide
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
Dulaglutide
Administered SC
Placebo
Participants received placebo administered as SC injection QW.
Placebo
Administered SC
Interventions
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LY3437943
Administered SC
Dulaglutide
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion Criteria
* Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or with a stable dose of metformin (either immediate release or extended release, 1000 milligram (mg)/day and not more than the locally approved dose) for at least 3 months prior to screening.
Exclusion Criteria
* Have ketoacidosis
* Have retinopathy, maculopathy
* Have history of pancreatitis
* Have obesity induced by other endocrine disorders
* Have uncontrolled hypertension
* Have acute or chronic hepatitis
* Have chronic kidney disease
* Have an autoimmune abnormality for example, lupus or rheumatoid arthritis
* Have an active or untreated malignancy
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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Syed Research Consultants Llc
Sheffield, Alabama, United States
San Fernando Valley Health Institute
Canoga Park, California, United States
Valley Endocrine, Fresno
Fresno, California, United States
National Research Institute - Huntington Park
Huntington Park, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
National Research Institute - Panorama City
Panorama City, California, United States
Anderson Clinical Research
Redlands, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
National Research Institute (NRI) - Santa Ana
Santa Ana, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
South Florida Clinical Research Institute
Margate, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Encore Medical Research - Weston
Weston, Florida, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Humphreys Diabetes Center
Boise, Idaho, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Elite Clinical Trials
Rexburg, Idaho, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Cotton O'Neil Clinic
Topeka, Kansas, United States
Centennial Medical Group
Elkridge, Maryland, United States
MediSync Clinical Research
Petal, Mississippi, United States
Clinvest Research LLC
Springfield, Missouri, United States
Logan Health Research
Kalispell, Montana, United States
Lillestol Research
Fargo, North Dakota, United States
Intend Research, LLC
Norman, Oklahoma, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
The Research Center of The Upstate
Greenville, South Carolina, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, United States
Endocrine Ips, Pllc
Houston, Texas, United States
Laila A Hassan, MD, PA
Houston, Texas, United States
Southern Endocrinology Associates
Mesquite, Texas, United States
North Hills Family Medicine/North Hills Medical Research
North Richland Hills, Texas, United States
Rainier Clinical Research Center
Renton, Washington, United States
Universal Research Group
Tacoma, Washington, United States
The Vancouver Clinic
Vancouver, Washington, United States
Advanced Clinical Research, LLC
Bayamón, , Puerto Rico
Manati Center for Clinical Research
Manatí, , Puerto Rico
Latin Clinical Trial Center
San Juan, , Puerto Rico
Countries
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References
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Coskun T, Wu Q, Schloot NC, Haupt A, Milicevic Z, Khouli C, Harris C. Effects of retatrutide on body composition in people with type 2 diabetes: a substudy of a phase 2, double-blind, parallel-group, placebo-controlled, randomised trial. Lancet Diabetes Endocrinol. 2025 Aug;13(8):674-684. doi: 10.1016/S2213-8587(25)00092-0. Epub 2025 Jun 30.
Rosenstock J, Frias J, Jastreboff AM, Du Y, Lou J, Gurbuz S, Thomas MK, Hartman ML, Haupt A, Milicevic Z, Coskun T. Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA. Lancet. 2023 Aug 12;402(10401):529-544. doi: 10.1016/S0140-6736(23)01053-X. 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 With Type 2 Diabetes
Other Identifiers
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J1I-MC-GZBD
Identifier Type: OTHER
Identifier Source: secondary_id
17774
Identifier Type: -
Identifier Source: org_study_id
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