A Study of LY3549492 in Healthy Participants

Healthy Clinical Trial

Official title:

A Randomized, Double-Blind, Single-Ascending Dose and Multiple-Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3549492 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04758234
• Other study ID #: 18082
• Secondary ID: J3H-MC-GZNA
• Status: Completed
• Phase: Phase 1
• Start date: February 22, 2021
• Est. completion date: January 10, 2022

Study information

• Verified date: February 1, 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in healthy participants. The blood tests will be performed to check how much LY3549492 gets into the bloodstream and how the body handles LY3549492. This study includes two parts and will last up to approximately 76 days for each participant, including screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy Males and females (excluding women of childbearing potential at the time of signing the informed consent)

• Glycated hemoglobin (HbA1c) value of <6.5% at screening

• Body mass index (BMI) within the range 20 to 40 kilograms per square meter (kg/m²), inclusive

• Capable of giving signed informed consent form (ICF)

Exclusion Criteria:

• Have obesity induced by endocrine disorders such as Cushing's syndrome or Prader-Willi syndrome.

• Have significant history of or current cardiovascular, respiratory, hepatic, renal, Gastro-intestine (GI) (including cholecystectomy with no sequelae, GI disease that significantly impact gastric emptying or motility, such as severe gastroparesis or pyloric stenosis even if treated), endocrine, hematological, psychiatric or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.

• Have undergone any form of bariatric surgery.

• Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase (>2.5 fold the upper limit of normal (ULN)).

• Have a personal or family history of medullary thyroid carcinoma or have Multiple Endocrine Neoplasia Syndrome Type 2.

• Have a serum calcitonin level of =20 nanogram/liter (ng/L) at screening, if estimated glomerular filtration rate is =60 milliliter/minute/1.73 square meter (mL/min/1.73 m2).

• Have an active or history of malignancy within 5 years prior to screening, except for basal cell or squamous epithelial carcinomas of the skin or in situ carcinoma of the uterine cervix that have been resected with no evidence or recurrence or metastatic disease for at least 3 years.

• Have known liver disease, obvious clinical signs, or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 2 times [ULN]).

• Have total bilirubin level (TBL) >1.5 × ULN (except for participants diagnosed with Gilbert's syndrome).

• Have serum triglyceride >500 milligram/deciliter (mg/dL) at screening.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3549492
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
United States	Covance Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

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 final follow-up at approximately Day 76
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3549492	PK: AUC of LY3549492	Predose up to 48 days postdose
Secondary	PK: Maximum Concentration (Cmax) of LY3549492	PK: Cmax of LY3549492	Predose up to 48 days postdose