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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02188303
First received: July 10, 2014
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: LY2944876
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of the Oxyntomodulin Analog, LY2944876, in Healthy Japanese Subjects and Healthy Non-Japanese Subjects

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator To Be Related to Study Drug Administration [ Time Frame: Predose through study completion (up to Day 53) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area Under the Concentration versus Time Curve (AUC) of LY2944876 [ Time Frame: Predose through study completion (up to Day 53) ] [ Designated as safety issue: No ]
  • Pharmacokinetics; Maximum Concentration (Cmax) of LY2944876 [ Time Frame: Predose through study completion (up to Day 53) ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: July 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2944876 (Single Dose)
Single escalating dose of LY2944876 administered subcutaneous (SC) on Day 1
Drug: LY2944876
Administered SC
Placebo Comparator: Placebo (Single Dose)
Single dose of placebo matching LY2944876 administered SC on Day 1
Drug: Placebo
Administered SC
Experimental: LY2944876 (Multiple Dose, Cohort 4)
LY2944876 administered once daily SC on Days 1 - 7
Drug: LY2944876
Administered SC
Placebo Comparator: Placebo (Multiple Dose, Cohort 4)
Placebo matching LY2944876 administered once daily SC on Days 1 - 7
Drug: Placebo
Administered SC
Experimental: LY2944876 (Multiple Dose, Cohort 5, Titrated)
LY2944876 in titrated doses administered once daily SC on Days 1, 4, 6, 8, 10 and 12
Drug: LY2944876
Administered SC
Placebo Comparator: Placebo (Multiple, Cohort 5)
Placebo matching LY2944876 administered once daily SC on Days 1, 4, 6, 8, 10 and 12
Drug: Placebo
Administered SC

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02188303

Contacts
Contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
United Kingdom
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. Recruiting
Leeds, West Yorkshire, United Kingdom
Contact: Eli Lilly         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02188303     History of Changes
Other Study ID Numbers: 15247, I7I-EW-XNAB
Study First Received: July 10, 2014
Last Updated: October 28, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on November 27, 2014