A Study of LY3457263 in Healthy Participants and Participants With Type 2 Diabetes

NCT ID: NCT04641312

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-25
• Study Completion Date: 2021-12-21

Brief Summary

The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 in healthy participants and participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study has two parts (part A and B). Each part will last up to 10 weeks and may include up to either 13 (part A) or 19 (part B) visits.

Conditions

Healthy; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3457263 - Part A

Escalating single doses of LY3457263 administered subcutaneously (SC) to healthy participants

Group Type: EXPERIMENTAL

LY3457263

Intervention Type: DRUG

Administered SC

Placebo - Part A

Placebo administered SC to healthy participants

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC

LY3457263 - Part B

Escalating single doses of LY3457263 administered SC in combination with Dulaglutide administered SC to participants with type 2 diabetes

Group Type: EXPERIMENTAL

LY3457263

Intervention Type: DRUG

Administered SC

Dulaglutide

Intervention Type: DRUG

Administered SC

Placebo - Part B

Placebo administered SC in combination with Dulaglutide administered SC to participants with type 2 diabetes

Group Type: PLACEBO_COMPARATOR

Dulaglutide

Intervention Type: DRUG

Administered SC

Placebo

Intervention Type: DRUG

Administered SC

Interventions

LY3457263

Administered SC

Intervention Type: DRUG

Dulaglutide

Administered SC

Intervention Type: DRUG

Placebo

Administered SC

Intervention Type: DRUG

Other Intervention Names

LY2189265

Eligibility Criteria

Inclusion Criteria

• Males that agree to use an effective method of contraception or agree to remain abstinent
• Females that are not of childbearing potential due to postmenopausal status or due to surgical sterility
• Part A only:

• Are overtly healthy
• Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²)
• Part B only:

• Have been diagnosed with Type 2 Diabetes (T2D) for at least 6 months prior to screening
• Be treated for T2D with stable dose of metformin, a stable dose of a dipeptidyl peptidase-4 (DPP-4) inhibitor with or without metformin, or a stable dose of a glucagon-like peptide-1 (GLP-1) receptor agonist with or without metformin for at least 3 months prior to screening
• BMI of 27 to 40 kg/m²

Exclusion Criteria

• Have undergone any form of bariatric surgery

• Have used or intend to use medications that promote weight loss within 3 months prior to screening, for the duration of the study
• Part A only:

• Have fasting plasma glucose (PG) levels ≥7 millimoles per liter (mmol/L) (≥126 milligrams per deciliter (mg/dL)) at screening
• Have Hemoglobin A1c (HbA1c) level ≥ 6.5% (48 millimoles per mole (mmol/mol)) at screening
• Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >20% and 10%, above the upper limit of normal (ULN), respectively. Elevation of total bilirubin level is considered acceptable in case of Gilbert's disease (with a normal direct bilirubin)
• Part B only:

• Have Type 1 Diabetes or latent autoimmune diabetes in adults
• Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
• Have known proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy
• Present comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) unless they are well-controlled with stable medication
• Have had an episode of severe hypoglycaemia within 6 months prior to screening, or have a history of hypoglycaemia unawareness or poor recognition of hypoglycaemia
• Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase >2 × ULN at screening
• Have a resting heart rate of <50 or >100 beats per minute
• Have an estimated glomerular filtration rate (<60 milliliter/minute (mL/min)/1.73 m2, or a level of estimated glomerular filtration rate that would contraindicate the use of metformin per the label in the respective country
• Have a screening calcitonin ≥20.0 picograms per milliliter (pg/mL)
• Fasting serum triglyceride level of >500 mg/dL at screening
• Have serum AST or ALT >3 × ULN or TBL >1.5 × ULN (except for participants diagnosed with Gilbert's syndrome)
• Have taken any prescription medication that are specifically indicated for lowering serum triglycerides within the last 3 months
• Have taken within the last 3 months any medications that interfere with absorption of dietary cholesterol or fats
• Use of medications known to prolong the QT/QTc interval
• Treated only with diet and exercise at study entry

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, Germany

Profil Mainz

Mainz, , Germany

Countries

Germany

Other Identifiers

2020-001828-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

J1R-MC-GZFA

Identifier Type: OTHER

Identifier Source: secondary_id

17261

Identifier Type: -

Identifier Source: org_study_id