A Study of LY2944876 in Healthy Japanese and Non-Japanese Participants

NCT ID: NCT02188303

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-12-31

Brief Summary

LY2944876 is an investigative drug for the treatment of Type 2 Diabetes Mellitus. Part A of the study will assess the safety and tolerability of single doses of LY2944876 in Japanese participants. Participation is expected to last up to about 7 weeks, not including screening.

Part B of the study will investigate the safety and tolerability of multiple doses of LY2944876 in non Japanese participants. Participation is expected to last up to about 8 weeks, not including screening.

All doses will be administered as injections into the fatty layer just beneath the skin.

Screening is required within 28 days prior to the start of the study. All participants will attend a post study safety assessment approximately 6 weeks after their final dose.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo (Single Dose, Cohorts 1-3)

Single dose of placebo matching LY2944876 administered subcutaneous (SC) on Day 1

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC

LY2944876 (Single Dose, Cohorts 1-3)

Single dose of 10 milligrams (mg) of LY2944876 administered SC on Day 1

Group Type: EXPERIMENTAL

LY2944876

Intervention Type: DRUG

Administered SC

Placebo (Multiple Dose, Cohort 4)

Placebo matching LY2944876 administered once daily SC on Days 1-7

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC

LY2944876 (Multiple Dose, Cohort 4)

40 mg LY2944876 administered once daily SC on Days 1-7

Group Type: EXPERIMENTAL

LY2944876

Intervention Type: DRUG

Administered SC

Placebo (Multiple, Cohort 5)

Placebo matching LY2944876 administered once daily SC on Days 1, 4, 6, 8, 10 and 12

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC

LY2944876 (Multiple Dose, Cohort 5, Titrated)

LY2944876 in titrated doses of 15 mg on Day 1, 30 mg on Day 4, up to 60 mg on Day 6, and up to 80 mg on Days 8, 10 and 12 administered once daily SC

Group Type: EXPERIMENTAL

LY2944876

Intervention Type: DRUG

Administered SC

Interventions

LY2944876

Administered SC

Intervention Type: DRUG

Placebo

Administered SC

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy males or female participants
• Are first generation Japanese participants (Part A) or non-Japanese participants (Part B)
• Have a body mass index (BMI) of 18.5 to 30 kilogram per meter square (kg/m^2), inclusive, for Part A and a BMI of 25 to 40 kg/m^2, inclusive, for Part B at screening
• Have normal blood pressure and heart rate (after approximately 5 minutes supine and approximately 2 minutes standing) as determined by the investigator at screening

Exclusion Criteria

• Have known allergies to LY2944876, related compounds or any components of the formulation, or history of significant atopy
• Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or baseline that, in the opinion of the investigator, increases the risks associated with participating in the study
• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, 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 a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase greater than 2 times the upper limit of normal (ULN) at screening and/or baseline
• Have known or ongoing psychiatric disorders considered clinically significant in the opinion of the investigator
• Have undergone any form of bariatric surgery
• Have fasting blood glucose levels greater than or equal to (≥) 7 millimoles per liter (mmol/L) [≥126 milligrams per deciliter (mg/dL)] at screening
• Have fasting triglycerides levels ≥300 mg/dL (3.4 mmol/L) at screening
• Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or an alanine transaminase (ALT) or aspartate aminotransferase (AST) levels greater than (>) 2.5 times the ULN at screening and/or baseline
• Have used or intend to use medications that promote weight loss, within 3 months prior to screening, for the duration of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

OPKO Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Leeds, West Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

I7I-EW-XNAB

Identifier Type: OTHER

Identifier Source: secondary_id

15247

Identifier Type: -

Identifier Source: org_study_id