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

NCT04641312 | Completed Phase 1 FDA Drug

• 3 other identifiers: 172612020-001828-34J1R-MC-GZFA
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline through Day 42

Secondary Outcomes (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

Study Arms (4)

LY3457263 - Part A

EXPERIMENTAL

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

Drug: LY3457263

Placebo - Part A

PLACEBO COMPARATOR

Placebo administered SC to healthy participants

Drug: Placebo

LY3457263 - Part B

EXPERIMENTAL

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

Drug: LY3457263; Drug: Dulaglutide

Placebo - Part B

PLACEBO COMPARATOR

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

Drug: Dulaglutide; Drug: Placebo

Interventions

LY3457263 DRUG

Administered SC

LY3457263 - Part A; LY3457263 - Part B

Dulaglutide DRUG

Administered SC

Also known as: LY2189265

LY3457263 - Part B; Placebo - Part B

Placebo DRUG

Administered SC

Placebo - Part A; Placebo - Part B

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, 41460, Germany

Location

Profil Mainz

Mainz, 55116, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 23, 2020
• Study Start: November 25, 2020
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)