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

NCT02188303 | Terminated Phase 1 Results

• 2 other identifiers: 15247I7I-EW-XNAB
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

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

  An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.

  Pre-dose (PRD) through Study Completion (Up to Day 40)

Secondary Outcomes (2)

• Pharmacokinetics: Area Under the Concentration Versus Time Curve - Time Zero to 168 Hours Post-dose [AUC(0-168h)] of LY2944876

  Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53

• Pharmacokinetics: Maximum Concentration (Cmax) of LY2944876

  Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53

Study Arms (6)

Placebo (Single Dose, Cohorts 1-3)

PLACEBO COMPARATOR

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

Drug: Placebo

LY2944876 (Single Dose, Cohorts 1-3)

EXPERIMENTAL

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

Drug: LY2944876

Placebo (Multiple Dose, Cohort 4)

PLACEBO COMPARATOR

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

Drug: Placebo

LY2944876 (Multiple Dose, Cohort 4)

EXPERIMENTAL

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

Drug: LY2944876

Placebo (Multiple, Cohort 5)

PLACEBO COMPARATOR

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

Drug: Placebo

LY2944876 (Multiple Dose, Cohort 5, Titrated)

EXPERIMENTAL

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

Drug: LY2944876

Interventions

LY2944876 DRUG

Administered SC

LY2944876 (Multiple Dose, Cohort 4); LY2944876 (Multiple Dose, Cohort 5, Titrated); LY2944876 (Single Dose, Cohorts 1-3)

Placebo DRUG

Administered SC

Placebo (Multiple Dose, Cohort 4); Placebo (Multiple, Cohort 5); Placebo (Single Dose, Cohorts 1-3)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (1)

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

Location

Results Point of Contact

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

ClinicalTrials.gov@lilly.com

800-545-5979

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: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 11, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 27, 2021
• Results First Posted: April 14, 2021

Record last verified: 2021-05

Locations

GB (1)