A Study of LY3437943 in Participants With Type 2 Diabetes

NCT ID: NCT04867785

Last Updated: 2023-07-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-13

Study Completion Date

2022-10-27

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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0.5 milligrams (mg) LY3437943

Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW).

Group Type EXPERIMENTAL

LY3437943

Intervention Type DRUG

Administered SC

4 mg LY3437943 (2 mg)

Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.

Group Type EXPERIMENTAL

LY3437943

Intervention Type DRUG

Administered SC

4 mg LY3437943 (4 mg)

Participants received 4 mg LY3437943 administered as SC injection QW.

Group Type EXPERIMENTAL

LY3437943

Intervention Type DRUG

Administered SC

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.

Group Type EXPERIMENTAL

LY3437943

Intervention Type DRUG

Administered SC

8 mg LY3437943 (4 mg)

Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.

Group Type EXPERIMENTAL

LY3437943

Intervention Type DRUG

Administered SC

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.

Group Type EXPERIMENTAL

LY3437943

Intervention Type DRUG

Administered SC

1.5 mg Dulaglutide

Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.

Group Type ACTIVE_COMPARATOR

Dulaglutide

Intervention Type DRUG

Administered SC

Placebo

Participants received placebo administered as SC injection QW.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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LY3437943

Administered SC

Intervention Type DRUG

Dulaglutide

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

Eli Lilly and Company

Locations

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Syed Research Consultants Llc

Sheffield, Alabama, United States

Site Status

San Fernando Valley Health Institute

Canoga Park, California, United States

Site Status

Valley Endocrine, Fresno

Fresno, California, United States

Site Status

National Research Institute - Huntington Park

Huntington Park, California, United States

Site Status

Catalina Research Institute, LLC

Montclair, California, United States

Site Status

National Research Institute - Panorama City

Panorama City, California, United States

Site Status

Anderson Clinical Research

Redlands, California, United States

Site Status

Artemis Institute for Clinical Research

Riverside, California, United States

Site Status

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status

National Research Institute (NRI) - Santa Ana

Santa Ana, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

South Florida Clinical Research Institute

Margate, Florida, United States

Site Status

ForCare Clinical Research

Tampa, Florida, United States

Site Status

Encore Medical Research - Weston

Weston, Florida, United States

Site Status

Elite Clinical Trials

Blackfoot, Idaho, United States

Site Status

Humphreys Diabetes Center

Boise, Idaho, United States

Site Status

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Site Status

Elite Clinical Trials

Rexburg, Idaho, United States

Site Status

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Site Status

Cotton O'Neil Clinic

Topeka, Kansas, United States

Site Status

Centennial Medical Group

Elkridge, Maryland, United States

Site Status

MediSync Clinical Research

Petal, Mississippi, United States

Site Status

Clinvest Research LLC

Springfield, Missouri, United States

Site Status

Logan Health Research

Kalispell, Montana, United States

Site Status

Lillestol Research

Fargo, North Dakota, United States

Site Status

Intend Research, LLC

Norman, Oklahoma, United States

Site Status

Heritage Valley Medical Group, Inc.

Beaver, Pennsylvania, United States

Site Status

Preferred Primary Care Physicians

Pittsburgh, Pennsylvania, United States

Site Status

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, United States

Site Status

Preferred Primary Care Physicians

Uniontown, Pennsylvania, United States

Site Status

The Research Center of The Upstate

Greenville, South Carolina, United States

Site Status

Dallas Diabetes Research Center

Dallas, Texas, United States

Site Status

Diabetes and Thyroid Center of Fort Worth

Fort Worth, Texas, United States

Site Status

Endocrine Ips, Pllc

Houston, Texas, United States

Site Status

Laila A Hassan, MD, PA

Houston, Texas, United States

Site Status

Southern Endocrinology Associates

Mesquite, Texas, United States

Site Status

North Hills Family Medicine/North Hills Medical Research

North Richland Hills, Texas, United States

Site Status

Rainier Clinical Research Center

Renton, Washington, United States

Site Status

Universal Research Group

Tacoma, Washington, United States

Site Status

The Vancouver Clinic

Vancouver, Washington, United States

Site Status

Advanced Clinical Research, LLC

Bayamón, , Puerto Rico

Site Status

Manati Center for Clinical Research

Manatí, , Puerto Rico

Site Status

Latin Clinical Trial Center

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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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.

Reference Type DERIVED
PMID: 40609566 (View on PubMed)

Rosenstock 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.

Reference Type DERIVED
PMID: 37385280 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://trials.lillytrialguide.com/en-US/trial/6tv02tRhvMamBP866x6OPm

A Study of LY3437943 in Participants With Type 2 Diabetes

Other Identifiers

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J1I-MC-GZBD

Identifier Type: OTHER

Identifier Source: secondary_id

17774

Identifier Type: -

Identifier Source: org_study_id

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