DRUG
LY3437943
Administered SC
Status
Completed
Phase
Phase 2
Enrollment
281
Locations
43
Results
Posted
Publications
2
Study 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.
Interventions
DRUG
Administered SC
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
Apr 30, 2021
Study start
May 13, 2021
Primary completion
Jul 8, 2022
Study completion
Oct 27, 2022
Results posted
Jul 3, 2023
Registry updated
Jul 3, 2023
Outcomes
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame · Baseline, 24 Weeks
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.
Change From Baseline in HbA1c
Time frame · Baseline, 24 Weeks
Change in HbA1c (%) from baseline in LY3437943 relative to dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.
Change From Baseline in HbA1c
Time frame · Baseline, 36 Weeks
Change in HbA1c (%) from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Baseline HbA1c Group (\<=8.5%, \>8.5%)\*Time + Baseline Body Mass Index (BMI) Group (\<30 kilograms/square meter (kg/m2), \>=30 kg/m2)\*Time + Baseline\*Time.
Percentage of Participants Reaching HbA1c <7.0%
Time frame · Week 24
Percentage of participants reaching HbA1c \<7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<30 kg/m2, ≥30 kg/m2\] as fixed effects, and baseline HbA1c value as a covariate.
Percentage of Participant Reaching HbA1c <7.0%
Time frame · Week 36
Percentage of participants reaching HbA1c \<7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<30 kg/m2, ≥30 kg/m2\] as fixed effects, and baseline HbA1c value as a covariate.
Change From Baseline in Fasting Blood Glucose (FBG)
Time frame · Baseline, 24 Weeks
Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.
Change From Baseline in Fasting Blood Glucose (FBG)
Time frame · Baseline, 36 Weeks
Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Baseline HbA1c Group (\<=8.5%, \>8.5%)\*Time + Baseline BMI Group (\<30kg/m2, \>=30kg/m2)\*Time + Baseline\*Time.
Change From Baseline in Body Weight
Time frame · Baseline, 24 Weeks
Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.
Change From Baseline in Body Weight
Time frame · Baseline, 36 Weeks
Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Baseline HbA1c Group (\<=8.5%, \>8.5%)\*Time + Baseline BMI Group (\<30kg/m2, \>=30kg/m2)\*Time + Baseline\*Time.
Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943
Time frame · Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36
The average steady-state plasma concentration of LY3437943 was evaluated using sparse sampling methodology/Population PK (PopPK) modeling.
Eligibility
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Study locations
Puerto Rico · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
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