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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04641312
Collaborator
(none)
67
2
4
12.8
33.5
2.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Nov 25, 2020
Actual Primary Completion Date :
Dec 21, 2021
Actual Study Completion Date :
Dec 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3457263 - Part A

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

Drug: LY3457263
Administered SC

Placebo Comparator: Placebo - Part A

Placebo administered SC to healthy participants

Drug: Placebo
Administered SC

Experimental: LY3457263 - Part B

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

Drug: LY3457263
Administered SC

Drug: Dulaglutide
Administered SC
Other Names:
  • LY2189265
  • Placebo Comparator: Placebo - Part B

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

    Drug: Dulaglutide
    Administered SC
    Other Names:
  • LY2189265
  • Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline through Day 42]

      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

    1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3457263 [Day 1 through Day 42]

      PK: AUC[0-inf] of LY3457263

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Profil Institut für Stoffwechselforschung Neuss Nordrhein-Westfalen Germany 41460
    2 Profil Mainz Mainz Germany 55116

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04641312
    Other Study ID Numbers:
    • 17261
    • 2020-001828-34
    • J1R-MC-GZFA
    First Posted:
    Nov 23, 2020
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 11, 2022