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Completed

NCT Number: NCT05048719

A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

The main purpose of this study is to evaluate the efficacy and safety of LY3502970 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 30 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

Bugát Pál Kórház, Gyöngyös, Heves County, Hungary

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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 been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of metformin
  • Have a stable body weight for the 3 months prior to randomization
  • Have a body mass index (BMI) ≥23 kilogram/square meter (kg/m²)
  • Males must agree to use highly effective methods of contraception
  • Women not of childbearing potential (WNOCBP) may participate in this trial
  • Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1.

Exclusion criteria

  • Have Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma
  • Have a history of diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that requires immediate treatment intervention
  • Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms
  • Have acute or chronic pancreatitis
  • Have obesity induced other endocrine disorders (Cushing's syndrome or Prader - Willi syndrome)
  • Have gastric emptying abnormality or chronically take medications impacting GI motility
  • Have poorly controlled hypertension
  • Have the following heart conditions within the last 6 months: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA), cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV heart failure
  • Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease (NAFLD)
  • Have HIV, or Hepatitis B or Hepatitis C

Treatment and study plan

LY3502970

Drug

Administered orally

Dulaglutide

Drug

Administered subcutaneously

Placebo

Drug

Administered orally

Primary outcomes

  1. Change From Baseline in HbA1c in LY3502970 as Compared to Placebo

    Time frame: Baseline, Week 26

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (<=8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

Secondary outcomes

  1. Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide

    Time frame: Baseline, Week 26

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (<=8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  2. Percentage of Participants With HbA1c ≤ 6.5%

    Time frame: Week 26

    Percentage of Participants with HbA1c ≤ 6.5%. Odds ratio was calculated using logistic regression model.

  3. Percentage of Participants With HbA1c <7.0%

    Time frame: Week 26

    Percentage of Participants with HbA1c <7.0%. Odds ratio was calculated using logistic regression model.

  4. Change From Baseline in Fasting Serum Glucose

    Time frame: Baseline, Week 26

    Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (<=8.0%, 8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  5. Change From Baseline in Body Weight

    Time frame: Baseline, Week 26

    LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (<=8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  6. Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970

    Time frame: Pre-dose (Week (wk) 0, wk 8, wk 12, and wk 26); Post-dose (wk 4, wk 8, wk 16, wk 20, and end of treatment).

    PK: Steady State AUC of LY3502970

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo and Once-Weekly Dulaglutide in Participants With Type 2 Diabetes Mellitus

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 17, 2021
Registry last updated
Oct 17, 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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