A Study of LY3437943 in Participants With Type 2 Diabetes

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04867785
Collaborator
(none)
300
43
6
17.5
7
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes
Actual Study Start Date :
May 13, 2021
Anticipated Primary Completion Date :
Jul 9, 2022
Anticipated Study Completion Date :
Oct 29, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3437943 Maintenance Dose 1

LY3437943 administered by subcutaneous (SC) injection

Drug: LY3437943
Administered SC

Experimental: LY3437943 Maintenance Dose 2

LY3437943 administered by SC injection

Drug: LY3437943
Administered SC

Experimental: LY3437943 Maintenance Dose 3

LY3437943 administered by SC injection

Drug: LY3437943
Administered SC

Experimental: LY3437943 Dose 4

LY3437943 administered by SC injection

Drug: LY3437943
Administered SC

Active Comparator: Dulaglutide

Dulaglutide will be given SC

Drug: Dulaglutide
Administered SC

Placebo Comparator: Placebo

Placebo will be given SC

Drug: Placebo
Administered SC

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, 24 Weeks]

    Change in HbA1c (%) from baseline in LY3437943 relative to placebo

Secondary Outcome Measures

  1. Change from Baseline in HbA1c [Baseline, 24 Weeks]

    Change in HbA1c (%) from baseline in LY3437943 relative to dulaglutide

  2. Change from Baseline in HbA1c [Baseline, 36 Weeks]

    Change in HbA1c (%) from baseline in LY3437943 relative to placebo and dulaglutide

  3. Percentage of Participant Reaching HbA1c <7.0% [Week 24]

    Percentage of participants reaching HbA1c <7.0% in LY3437943 relative to placebo and dulaglutide

  4. Percentage of Participant Reaching HbA1c <7.0% [Week 36]

    Percentage of participants reaching HbA1c <7.0% in LY3437943 relative to placebo and dulaglutide

  5. Change from Baseline in Fasting Blood Glucose (FBG) [Baseline, 24 Weeks]

    Change in FBG in LY3437943 relative to placebo and dulaglutide

  6. Change from Baseline in Fasting Blood Glucose (FBG) [Baseline, 36 Weeks]

    Change in FBG in LY3437943 relative to placebo and dulaglutide

  7. Change from Baseline in Body Weight [Baseline, 24 Weeks]

    Change in body weight in LY3437943 relative to placebo and dulaglutide

  8. Change from Baseline in Body Weight [Baseline, 36 Weeks]

    Change in body weight in LY3437943 relative to placebo and dulaglutide

  9. Pharmacokinetics (PK) Plasma concentration of LY3437943 [Predose: Week 0, 1, 4, 12, 24, 30, 36 Postdose: Week 2, 8, 16, 20]

    Plasma concentration of LY3437943 will be assessed

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Syed Research Consultants Llc Sheffield Alabama United States 35660
2 San Fernando Valley Health Institute Canoga Park California United States 91304
3 Valley Endocrine, Fresno Fresno California United States 93720
4 National Research Institute - Huntington Park Huntington Park California United States 90255
5 Catalina Research Institute, LLC Montclair California United States 91763
6 National Research Institute - Panorama City Panorama City California United States 91402
7 Anderson Clinical Research Redlands California United States 92374
8 Artemis Institute for Clinical Research Riverside California United States 92503
9 Artemis Institute for Clinical Research San Diego California United States 92103
10 National Research Institute (NRI) - Santa Ana Santa Ana California United States 92704
11 Diablo Clinical Research, Inc. Walnut Creek California United States 94598
12 South Florida Clinical Research Institute Margate Florida United States 33063
13 ForCare Clinical Research Tampa Florida United States 33613
14 Encore Medical Research - Weston Weston Florida United States 33331
15 Elite Clinical Trials Blackfoot Idaho United States 83221
16 Humphreys Diabetes Center Boise Idaho United States 83702
17 Rocky Mountain Clinical Research Idaho Falls Idaho United States 83404
18 Elite Clinical Trials Rexburg Idaho United States 83440
19 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
20 Cotton O'Neil Clinic Topeka Kansas United States 66606
21 Centennial Medical Group Elkridge Maryland United States 21075
22 MediSync Clinical Research Petal Mississippi United States 39465
23 Clinvest Research LLC Springfield Missouri United States 65810
24 Logan Health Research Kalispell Montana United States 59901
25 Lillestol Research Fargo North Dakota United States 58104
26 Intend Research, LLC Norman Oklahoma United States 73069
27 Heritage Valley Medical Group, Inc. Beaver Pennsylvania United States 15009
28 Preferred Primary Care Physicians Pittsburgh Pennsylvania United States 15236
29 Frontier Clinical Research, LLC Smithfield Pennsylvania United States 15478
30 Preferred Primary Care Physicians Uniontown Pennsylvania United States 15401
31 The Research Center of The Upstate Greenville South Carolina United States 29607
32 Dallas Diabetes Research Center Dallas Texas United States 75230
33 Diabetes and Thyroid Center of Fort Worth Fort Worth Texas United States 76132
34 Endocrine Ips, Pllc Houston Texas United States 77079
35 Laila A Hassan, MD, PA Houston Texas United States 77089
36 Southern Endocrinology Associates Mesquite Texas United States 75149
37 North Hills Family Medicine/North Hills Medical Research North Richland Hills Texas United States 76180
38 Rainier Clinical Research Center Renton Washington United States 98057
39 Universal Research Group Tacoma Washington United States 98405
40 The Vancouver Clinic Vancouver Washington United States 98664
41 Advanced Clinical Research, LLC Bayamon Puerto Rico 00961
42 Manati Center for Clinical Research Manati Puerto Rico 674
43 Latin Clinical Trial Center San Juan Puerto Rico 909

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04867785
Other Study ID Numbers:
  • 17774
  • J1I-MC-GZBD
First Posted:
Apr 30, 2021
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 15, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2022