Healthy Clinical Trial
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
Verified date | January 1, 2022 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | December 21, 2021 |
Est. primary completion date | December 21, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Profil Mainz | Mainz | |
Germany | Profil Institut für Stoffwechselforschung | Neuss | Nordrhein-Westfalen |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | Day 1 through Day 42 |
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