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Completed

NCT Number: NCT04758234

A Study of LY3549492 in Healthy Participants

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Dallas

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3549492

Drug

Administered orally.

Placebo

Drug

Administered orally.

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

    Time frame: Baseline through final follow-up at approximately Day 76

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3549492

    Time frame: Predose up to 48 days postdose

    PK: AUC of LY3549492

  2. PK: Maximum Concentration (Cmax) of LY3549492

    Time frame: Predose up to 48 days postdose

    PK: Cmax of LY3549492

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2021
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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