A Study of LY3493269 in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Placebo
Drug: LY3493269
Drug: Salcaprozate Sodium

Registration Number: NCT04682106

Lead Sponsor: Eli Lilly and Company

Brief Summary: The main purpose of this study is to evaluate the safety and tolerability of LY3493269 in healthy participants. The blood tests will be performed to check how much LY3493269 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3493269. The study will last up to approximately 71 days for each participant, including screening

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

Inclusion Criteria

Are male or female not of childbearing potential
Body mass index within the range of 19.0 to 40.0 kilograms per square meter (kg/m²) (inclusive)
Participants who are healthy as determined through medical evaluation including screening medical history, physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG)
Have clinical laboratory test results within normal reference range for the population or clinical research unit (CRU), or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have venous access sufficient to allow blood sampling as per the protocol.

Exclusion Criteria

Have a significant history of or current CV (for example, myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, renal, GI, endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the IP; or of interfering with the interpretation of data
Have undergone any form of bariatric surgery
Have a history of gastrointestinal (GI) bleeding or duodenal ulcers
Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
Have a history of acute or chronic pancreatitis, or elevation in serum lipase and/or amylase levels greater than 1.5 times the upper limit of normal (ULN)
Have clinical signs or symptoms of liver disease, acute or chronic hepatitis
Have evidence of significant active neuropsychiatric disease as determined by the investigator
Have been treated with prescription drugs that promote weight loss within 3 months prior to screening
Are currently enrolled in a clinical study involving an IP or any other type of medical research judged not to be scientifically or medically compatible with this study
Have participated within the past 30 days of screening in a clinical study involving an investigational product (IP); at least 5 half-lives or 30 days, whichever is longer, should have passed
Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG (QT) data analysis, such as a QTcF greater than (>) 450 milliseconds (msec) for males and > 470 msec for females, short PR interval (< 120 msec), or PR interval > 220 msec, second and third atrioventricular block, intraventricular conduction delay with QRS >120 msec, right bundle branch block, left bundle branch block or Wolff-Parkinson-White syndrome
Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times (X) ULN or total bilirubin level (TBL) >1.5X ULN
Show evidence of HIV infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B, positive hepatitis B core antibody, and/or positive hepatitis B surface antigen
Have donated blood of more than 450 mL, or have participated in a clinical study that required similar blood volume drawn within the past 3 calendar months
Have known allergies to LY3493269, related compounds, or any components of the formulation (including SNAC), or a history of significant atopy

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC)	Salcaprozate Sodium	Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
Placebo	Placebo	Participants received placebo orally once daily (QD) for three consecutive days.
8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC)	LY3493269	Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
24 mg LY3493269 + 600 mg SNAC	LY3493269	Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
24 mg LY3493269 + 600 mg SNAC	Salcaprozate Sodium	Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
12 mg LY3493269 + 300 mg SNAC	LY3493269	Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
12 mg LY3493269 + 300 mg SNAC	Salcaprozate Sodium	Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
4 mg LY3493269 + 300 mg SNAC	Salcaprozate Sodium	Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
4 mg LY3493269 + 300 mg SNAC	LY3493269	Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs)	Baseline through Day 44	TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. A summary of serious adverse events (SAEs), TEAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Adverse Events section of this record.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC [0-24]) of LY3493269	Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose	PK: AUC (0-24) of LY3493269
PK: Maximum Concentration (Cmax) of LY3493269	Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose	PK: Cmax of LY3493269