Clinical trial NCT04867785: A Study of LY3437943 in Participants With Type 2 Diabetes
Official title: A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-04-30
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 24 Weeks
Secondary outcomes:
measure: Change From Baseline in HbA1c
timeFrame: Baseline, 24 Weeks
measure: Change From Baseline in HbA1c
timeFrame: Baseline, 36 Weeks
measure: Percentage of Participants Reaching HbA1c <7.0%
timeFrame: Week 24
measure: Percentage of Participant Reaching HbA1c <7.0%
timeFrame: Week 36
measure: Change From Baseline in Fasting Blood Glucose (FBG)
timeFrame: Baseline, 24 Weeks
measure: Change From Baseline in Fasting Blood Glucose (FBG)
timeFrame: Baseline, 36 Weeks
measure: Change From Baseline in Body Weight
timeFrame: Baseline, 24 Weeks
measure: Change From Baseline in Body Weight
timeFrame: Baseline, 36 Weeks
measure: Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943
timeFrame: Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Syed Research Consultants Llc
state: Alabama
city: Canoga Park
country: United States
facility: San Fernando Valley Health Institute
state: California
city: Fresno
country: United States
facility: Valley Endocrine, Fresno
state: California
city: Huntington Park
country: United States
facility: National Research Institute - Huntington Park
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Panorama City
country: United States
facility: National Research Institute - Panorama City
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Santa Ana
country: United States
facility: National Research Institute (NRI) - Santa Ana
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Margate
country: United States
facility: South Florida Clinical Research Institute
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Weston
country: United States
facility: Encore Medical Research - Weston
state: Florida
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Boise
country: United States
facility: Humphreys Diabetes Center
state: Idaho
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Rexburg
country: United States
facility: Elite Clinical Trials
state: Idaho
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Clinic
state: Kansas
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Petal
country: United States
facility: MediSync Clinical Research
state: Mississippi
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Kalispell
country: United States
facility: Logan Health Research
state: Montana
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Norman
country: United States
facility: Intend Research, LLC
state: Oklahoma
city: Beaver
country: United States
facility: Heritage Valley Medical Group, Inc.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Greenville
country: United States
facility: The Research Center of The Upstate
state: South Carolina
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Fort Worth
country: United States
facility: Diabetes and Thyroid Center of Fort Worth
state: Texas
city: Houston
country: United States
facility: Endocrine Ips, Pllc
state: Texas
city: Houston
country: United States
facility: Laila A Hassan, MD, PA
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Family Medicine/North Hills Medical Research
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Tacoma
country: United States
facility: Universal Research Group
state: Washington
city: Vancouver
country: United States
facility: The Vancouver Clinic
state: Washington
city: Bayamon
country: Puerto Rico
facility: Advanced Clinical Research, LLC
city: Manati
country: Puerto Rico
facility: Manati Center for Clinical Research
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: