A Study of LY3493269 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3493269; Drug: Placebo; Drug: Salcaprozate Sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT04682106

J1X-MC-GZHF (Other Identifier)

17552

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Are male or female not of childbearing potential
2. Body mass index within the range of 19.0 to 40.0 kilograms per square meter (kg/m²) (inclusive)
3. Participants who are healthy as determined through medical evaluation including screening medical history, physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG)
4. 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
5. Have venous access sufficient to allow blood sampling as per the protocol.

Exclusion criteria

1. 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
2. Have undergone any form of bariatric surgery
3. Have a history of gastrointestinal (GI) bleeding or duodenal ulcers
4. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
5. 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)
6. Have clinical signs or symptoms of liver disease, acute or chronic hepatitis
7. Have evidence of significant active neuropsychiatric disease as determined by the investigator
8. Have been treated with prescription drugs that promote weight loss within 3 months prior to screening
9. 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
10. 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
11. 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
12. Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times (X) ULN or total bilirubin level (TBL) >1.5X ULN
13. Show evidence of HIV infection and/or positive human HIV antibodies
14. Show evidence of hepatitis C and/or positive hepatitis C antibody
15. Show evidence of hepatitis B, positive hepatitis B core antibody, and/or positive hepatitis B surface antigen
16. 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
17. Have known allergies to LY3493269, related compounds, or any components of the formulation (including SNAC), or a history of significant atopy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: Salcaprozate Sodium

Drug: LY3493269

24 mg LY3493269 + 600 mg SNAC

Experimental group

Description:

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

Treatment:

Drug: Salcaprozate Sodium

Drug: LY3493269

12 mg LY3493269 + 300 mg SNAC

Experimental group

Description:

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

Treatment:

Drug: Salcaprozate Sodium

Drug: LY3493269

4 mg LY3493269 + 300 mg SNAC

Experimental group

Description:

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

Treatment:

Drug: Salcaprozate Sodium

Drug: LY3493269