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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Placebo; Drug: Dulaglutide; Drug: LY3437943

• Study Type: Interventional
• Enrollment (Actual): 281
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • Bayamon, Puerto Rico, 00961
    • Advanced Clinical Research, LLC
  • Manati, Puerto Rico, 674
    • Manati Center for Clinical Research
  • San Juan, Puerto Rico, 909
    • Latin Clinical Trial Center
• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
      • Syed Research Consultants LLC
  • California
    • Canoga Park, California, United States, 91304
      • San Fernando Valley Health Institute
    • Fresno, California, United States, 93720
      • Valley Endocrine, Fresno
    • Huntington Park, California, United States, 90255
      • National Research Institute - Huntington Park
    • Montclair, California, United States, 91763
      • Catalina Research Institute, LLC
    • Panorama City, California, United States, 91402
      • National Research Institute - Panorama City
    • Redlands, California, United States, 92374
      • Anderson Clinical Research
    • Riverside, California, United States, 92503
      • Artemis Institute for Clinical Research
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • Santa Ana, California, United States, 92704
      • National Research Institute (NRI) - Santa Ana
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Florida
    • Margate, Florida, United States, 33063
      • South Florida Clinical Research Institute
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research
    • Weston, Florida, United States, 33331
      • Encore Medical Research - Weston
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials
    • Boise, Idaho, United States, 83702
      • Humphreys Diabetes Center
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Clinical Research
    • Rexburg, Idaho, United States, 83440
      • Elite Clinical Trials
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diabetes and Endocrinology Research Center
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinic
  • Maryland
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical Group
  • Mississippi
    • Petal, Mississippi, United States, 39465
      • MediSync Clinical Research
  • Missouri
    • Springfield, Missouri, United States, 65810
      • Clinvest Research LLC
  • Montana
    • Kalispell, Montana, United States, 59901
      • Logan Health Research
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Intend Research, LLC
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Heritage Valley Medical Group, Inc.
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research, LLC
    • Uniontown, Pennsylvania, United States, 15401
      • Preferred Primary Care Physicians
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • The Research Center of The Upstate
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes Research Center
    • Fort Worth, Texas, United States, 76132
      • Diabetes and Thyroid Center of Fort Worth
    • Houston, Texas, United States, 77079
      • Endocrine Ips, Pllc
    • Houston, Texas, United States, 77089
      • Laila A Hassan, MD, PA
    • Mesquite, Texas, United States, 75149
      • Southern Endocrinology Associates
    • North Richland Hills, Texas, United States, 76180
      • North Hills Family Medicine/North Hills Medical Research
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center
    • Tacoma, Washington, United States, 98405
      • Universal Research Group
    • Vancouver, Washington, United States, 98664
      • The Vancouver Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.5 milligrams (mg) LY3437943; Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW).	Drug: LY3437943; Administered SC
Experimental: 4 mg LY3437943 (2 mg); Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.	Drug: LY3437943; Administered SC
Experimental: 4 mg LY3437943 (4 mg); Participants received 4 mg LY3437943 administered as SC injection QW.	Drug: LY3437943; Administered SC
Experimental: 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.	Drug: LY3437943; Administered SC
Experimental: 8 mg LY3437943 (4 mg); Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.	Drug: LY3437943; Administered SC
Experimental: 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.	Drug: LY3437943; Administered SC
Active Comparator: 1.5 mg Dulaglutide; Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.	Drug: Dulaglutide; Administered SC
Placebo Comparator: Placebo; Participants received placebo administered as SC injection QW.	Drug: Placebo; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c	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.	Baseline, 24 Weeks
Change From Baseline in HbA1c	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.	Baseline, 36 Weeks
Percentage of Participants Reaching HbA1c <7.0%	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.	Week 24
Percentage of Participant Reaching HbA1c <7.0%	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.	Week 36
Change From Baseline in Fasting Blood Glucose (FBG)	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.	Baseline, 24 Weeks
Change From Baseline in Fasting Blood Glucose (FBG)	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.	Baseline, 36 Weeks
Change From Baseline in Body Weight	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.	Baseline, 24 Weeks
Change From Baseline in Body Weight	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.	Baseline, 36 Weeks
Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943	The average steady-state plasma concentration of LY3437943 was evaluated using sparse sampling methodology/Population PK (PopPK) modeling.	Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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

Publications and helpful links

Helpful Links

• A Study of LY3437943 in Participants With Type 2 Diabetes

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2021
• Primary Completion (Actual): July 8, 2022
• Study Completion (Actual): October 27, 2022

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Dulaglutide
• Other Study ID Numbers: 17774; J1I-MC-GZBD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No