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

Primary Purpose

Healthy, Type 2 Diabetes

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
LY3457263
Dulaglutide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Profil Institut für Stoffwechselforschung
  • Profil Mainz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

LY3457263 - Part A

Placebo - Part A

LY3457263 - Part B

Placebo - Part B

Arm Description

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

Placebo administered SC to healthy participants

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

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

Outcomes

Primary Outcome Measures

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3457263
PK: AUC[0-inf] of LY3457263

Full Information

First Posted
November 20, 2020
Last Updated
January 10, 2022
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04641312
Brief Title
A Study of LY3457263 in Healthy Participants and Participants With Type 2 Diabetes
Official Title
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3457263 in Healthy Participants and in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 1, 2022
Overall Recruitment Status
Completed
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
December 21, 2021 (Actual)
Study Completion Date
December 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Type 2 Diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3457263 - Part A
Arm Type
Experimental
Arm Description
Escalating single doses of LY3457263 administered subcutaneously (SC) to healthy participants
Arm Title
Placebo - Part A
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC to healthy participants
Arm Title
LY3457263 - Part B
Arm Type
Experimental
Arm Description
Escalating single doses of LY3457263 administered SC in combination with Dulaglutide administered SC to participants with type 2 diabetes
Arm Title
Placebo - Part B
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC in combination with Dulaglutide administered SC to participants with type 2 diabetes
Intervention Type
Drug
Intervention Name(s)
LY3457263
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Other Intervention Name(s)
LY2189265
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time Frame
Baseline through Day 42
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3457263
Description
PK: AUC[0-inf] of LY3457263
Time Frame
Day 1 through Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Profil Institut für Stoffwechselforschung
City
Neuss
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41460
Country
Germany
Facility Name
Profil Mainz
City
Mainz
ZIP/Postal Code
55116
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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