A Study of LY3549492 in Healthy Participants

NCT04758234 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18082J3H-MC-GZNA
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

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 final follow-up at approximately Day 76

Secondary Outcomes (2)

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

  Predose up to 48 days postdose

• PK: Maximum Concentration (Cmax) of LY3549492

  Predose up to 48 days postdose

Study Arms (3)

LY3549492 (Part A)

EXPERIMENTAL

LY3549492 administered orally as single ascending doses.

Drug: LY3549492

LY3549492 (Part B)

EXPERIMENTAL

LY3549492 administered orally as multiple ascending doses.

Drug: LY3549492

Placebo

PLACEBO COMPARATOR

Placebo administered orally.

Drug: Placebo

Interventions

LY3549492 DRUG

Administered orally.

LY3549492 (Part A); LY3549492 (Part B)

Placebo DRUG

Administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Dallas

Dallas, Texas, 75247, United States

Location

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: February 16, 2021
• First Posted: February 17, 2021
• Study Start: February 22, 2021
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-02-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)