A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

Lilly

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: LY3502970; Drug: Placebo; Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05048719

17787 (Other Identifier)

J2A-MC-GZGE (Other Identifier)

2021-002806-29 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 383 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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383 participants in 9 patient groups, including a placebo group

3 milligrams (mg) LY3502970

Experimental group

Description:

Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).

Treatment:

Drug: LY3502970

12 mg LY3502970

Experimental group

Description:

Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.

Treatment:

Drug: LY3502970

24 mg LY3502970

Experimental group

Description:

Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.

Treatment:

Drug: LY3502970

36 mg LY3502970 - 1

Experimental group

Description:

Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.

Treatment:

Drug: LY3502970

36 mg LY3502970 - 2

Experimental group

Description:

Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.

Treatment:

Drug: LY3502970

45 mg LY3502970 - 1

Experimental group

Description:

Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.

Treatment:

Drug: LY3502970

45 mg LY3502970 - 2

Experimental group

Description:

Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.

Treatment:

Drug: LY3502970

1.5 mg Dulaglutide

Active Comparator group

Description:

Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).

Treatment:

Drug: Dulaglutide

Placebo

Placebo Comparator group

Description:

Participants received matching placebo.

Treatment:

Drug: Placebo

Drug: Placebo