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Completed

NCT Number: NCT04867785

A Study of LY3437943 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Advanced Clinical Research, LLC, Bayamón, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3437943

Drug

Administered SC

Dulaglutide

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 30, 2021
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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