Current partner codePEPTIDESDE
NCT04867785·Phase 2·INTERVENTIONAL

A Study of LY3437943 in Participants With Type 2 Diabetes

Status

Completed

Phase

Phase 2

Enrollment

281

Locations

43

Results

Posted

Publications

2

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

LY3437943

Administered SC

DRUG

Dulaglutide

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Apr 30, 2021

  2. Study start

    May 13, 2021

  3. Primary completion

    Jul 8, 2022

  4. Study completion

    Oct 27, 2022

  5. Results posted

    Jul 3, 2023

  6. Registry updated

    Jul 3, 2023

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
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

Study locations

43 registered sites.

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

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