A Study of LY3437943 in Participants With Type 2 Diabetes
A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes
2 other identifiers
interventional
281
2 countries
43
Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 43 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes
Started May 2021
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2021
CompletedFirst Posted
Study publicly available on registry
April 30, 2021
CompletedStudy Start
First participant enrolled
May 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2022
CompletedResults Posted
Study results publicly available
July 3, 2023
CompletedJuly 3, 2023
June 1, 2023
1.2 years
April 29, 2021
June 8, 2023
June 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c)
Change in HbA1c (%) from baseline in LY3437943 relative to placebo. HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.
Baseline, 24 Weeks
Secondary Outcomes (9)
Change From Baseline in HbA1c
Baseline, 24 Weeks
Change From Baseline in HbA1c
Baseline, 36 Weeks
Percentage of Participants Reaching HbA1c <7.0%
Week 24
Percentage of Participant Reaching HbA1c <7.0%
Week 36
Change From Baseline in Fasting Blood Glucose (FBG)
Baseline, 24 Weeks
- +4 more secondary outcomes
Study Arms (8)
0.5 milligrams (mg) LY3437943
EXPERIMENTALParticipants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW).
4 mg LY3437943 (2 mg)
EXPERIMENTALParticipants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
4 mg LY3437943 (4 mg)
EXPERIMENTALParticipants received 4 mg LY3437943 administered as SC injection QW.
8 mg LY3437943 (2 mg)
EXPERIMENTALParticipants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
8 mg LY3437943 (4 mg)
EXPERIMENTALParticipants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.
12 mg LY3437943 (2 mg)
EXPERIMENTALParticipants 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.
1.5 mg Dulaglutide
ACTIVE COMPARATORParticipants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
Placebo
PLACEBO COMPARATORParticipants received placebo administered as SC injection QW.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Have Type 2 Diabetes (T2D)
- 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.
You may not qualify if:
- Have type 1 diabetes mellitus (T1DM)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Syed Research Consultants Llc
Sheffield, Alabama, 35660, United States
San Fernando Valley Health Institute
Canoga Park, California, 91304, United States
Valley Endocrine, Fresno
Fresno, California, 93720, United States
National Research Institute - Huntington Park
Huntington Park, California, 90255, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
National Research Institute - Panorama City
Panorama City, California, 91402, United States
Anderson Clinical Research
Redlands, California, 92374, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
National Research Institute (NRI) - Santa Ana
Santa Ana, California, 92704, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
South Florida Clinical Research Institute
Margate, Florida, 33063, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Encore Medical Research - Weston
Weston, Florida, 33331, United States
Elite Clinical Trials
Blackfoot, Idaho, 83221, United States
Humphreys Diabetes Center
Boise, Idaho, 83702, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
Elite Clinical Trials
Rexburg, Idaho, 83440, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
Cotton O'Neil Clinic
Topeka, Kansas, 66606, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
MediSync Clinical Research
Petal, Mississippi, 39465, United States
Clinvest Research LLC
Springfield, Missouri, 65810, United States
Logan Health Research
Kalispell, Montana, 59901, United States
Lillestol Research
Fargo, North Dakota, 58104, United States
Intend Research, LLC
Norman, Oklahoma, 73069, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, 15009, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, 15236, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
The Research Center of The Upstate
Greenville, South Carolina, 29607, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, 76132, United States
Endocrine Ips, Pllc
Houston, Texas, 77079, United States
Laila A Hassan, MD, PA
Houston, Texas, 77089, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
North Hills Family Medicine/North Hills Medical Research
North Richland Hills, Texas, 76180, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Universal Research Group
Tacoma, Washington, 98405, United States
The Vancouver Clinic
Vancouver, Washington, 98664, United States
Advanced Clinical Research, LLC
Bayamón, 00961, Puerto Rico
Manati Center for Clinical Research
Manatí, 674, Puerto Rico
Latin Clinical Trial Center
San Juan, 909, Puerto Rico
Related Publications (2)
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.
PMID: 40609566DERIVEDRosenstock 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.
PMID: 37385280DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2021
First Posted
April 30, 2021
Study Start
May 13, 2021
Primary Completion
July 8, 2022
Study Completion
October 27, 2022
Last Updated
July 3, 2023
Results First Posted
July 3, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and 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.
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.