A Study of LY3493269 in Healthy Participants

NCT04682106 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17552J1X-MC-GZHF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs)

  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.

  Baseline through Day 44

Secondary Outcomes (2)

• 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: 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

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Participants received placebo orally once daily (QD) for three consecutive days.

Drug: Placebo

8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC)

EXPERIMENTAL

Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.

Drug: LY3493269; Drug: Salcaprozate Sodium

24 mg LY3493269 + 600 mg SNAC

EXPERIMENTAL

Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.

Drug: LY3493269; Drug: Salcaprozate Sodium

12 mg LY3493269 + 300 mg SNAC

EXPERIMENTAL

Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.

Drug: LY3493269; Drug: Salcaprozate Sodium

4 mg LY3493269 + 300 mg SNAC

EXPERIMENTAL

Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.

Drug: LY3493269; Drug: Salcaprozate Sodium

Interventions

LY3493269 DRUG

Administered orally.

12 mg LY3493269 + 300 mg SNAC; 24 mg LY3493269 + 600 mg SNAC; 4 mg LY3493269 + 300 mg SNAC; 8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC)

Placebo DRUG

Administered orally.

Placebo

Salcaprozate Sodium DRUG

Administered orally.

12 mg LY3493269 + 300 mg SNAC; 24 mg LY3493269 + 600 mg SNAC; 4 mg LY3493269 + 300 mg SNAC; 8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

MeSH Terms

Interventions

N-(8-(2-hydroxybenzoyl)amino)caprylate

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

8005455979

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

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: December 22, 2020
• First Posted: December 23, 2020
• Study Start: May 3, 2021
• Primary Completion: November 11, 2021
• Study Completion: November 11, 2021
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)