A Single Dose Study of LY2189265 in Subjects With Varying Degrees of Hepatic (Liver) Impairment

NCT01253304 | Completed Phase 1 Results

• 2 other identifiers: 13765H9X-EW-GBDO
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 2

Brief Summary

The primary purpose of this study is to help answer the following research questions, and not to provide treatment for any condition:

• To evaluate how much of the study drug (LY2189265) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function.
• To assess the safety of LY2189265 and any side effects that might be associated with it.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (7)

• Pharmacokinetics: Maximum Observed Concentration (Cmax)

  This measure was calculated using non-compartmental analysis techniques.

  Predose to 336 hours postdose

• Pharmacokinetics: Time of Maximum Concentration (Tmax)

  This measure was calculated using non-compartmental analysis techniques.

  Predose to 336 hours postdose

• Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast])

  This measure was calculated using non-compartmental analysis techniques.

  Predose to 336 hours postdose

• Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity])

  This measure was calculated using non-compartmental analysis techniques.

  Predose to 336 hours postdose

• Pharmacokinetics: Apparent Terminal Elimination Half-life (t1/2)

  The half life associated with the terminal rate constant is summarized. This measure was calculated using non-compartmental analysis techniques.

  Predose to 336 hours postdose

• Pharmacokinetics: Apparent Total Plasma Clearance (CL/F)

  The apparent total body clearance of drug calculated after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.

  Predose to 336 hours postdose

• Pharmacokinetics: Apparent Volume of Distribution (Vz/F)

  The apparent volume of distribution during the terminal phase after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.

  Predose to 336 hours postdose

Study Arms (4)

Normal hepatic function

EXPERIMENTAL

LY2189265: A single, subcutaneous (SC) 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function

Drug: LY2189265

Mild hepatic impairment

EXPERIMENTAL

LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)

Drug: LY2189265

Moderate hepatic impairment

EXPERIMENTAL

LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)

Drug: LY2189265

Severe hepatic impairment

EXPERIMENTAL

LY2189265: A single, SC-1.5 mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)

Drug: LY2189265

Interventions

LY2189265 DRUG

Subcutaneous (SC) injection

Also known as: Dulaglutide

Mild hepatic impairment; Moderate hepatic impairment; Normal hepatic function; Severe hepatic impairment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Participants (including participants with type 2 diabetes mellitus \[T2DM\]):
• Male participants - Agree to use a reliable method of birth control (for example, barrier methods) during the study and for at least 3 months following dosing of study drug
• Female participants:
• Women must be of non-child-bearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause
• Women with an intact uterus are deemed postmenopausal if they are over 45 years old and have had cessation of menses for at least 1 year or have had 6 to 12 months of spontaneous amenorrhea with follicle stimulating hormone (FSH) \>40 international units per milliliter (IU/mL) and have not taken hormone replacement therapy or oral contraceptives within 1 year of study start and are otherwise healthy
• Women who have had cessation of menses for at least 2 years are permitted to take hormone replacement therapy
• Have a body mass index (BMI) between 19.0 and 40.0 kilograms per meters squared (kg/m\^2), inclusive, at screening.
• Have venous access sufficient to allow blood sampling
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
• Have given written informed consent approved by Lilly and the ethical review board governing the site
• Control Participants:
• Overtly healthy participants with normal hepatic function
• Participants with T2DM with normal hepatic function
• Have normal sitting blood pressure and pulse rate as determined by the investigator or with changes compatible with their age and disease status in case of patients with T2DM
• Have clinical laboratory test results within normal reference range for the investigator site or results with minor deviations not considered to be clinically significant by the investigator or with changes compatible with their age and disease status in case of T2DM

You may not qualify if:

• All participants (including participants with T2DM)
• Are currently enrolled in, discontinued within the last 30 days from a clinical trial involving use of an investigational drug or device other than the study drug, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• Have known allergies to LY2189265 or related compounds
• Have previously completed or withdrawn from this study or any other study investigating LY2189265
• Have a current, functioning organ transplant
• Show evidence of significant active, uncontrolled, endocrine or autoimmune abnormalities (such as, thyroid disease or pernicious anemia) as judged by the screening physician
• Have shown febrile illness within 3 days prior to screening
• Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening that are not otherwise explained by permitted concomitant medications
• Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
• Are women with a positive pregnancy test or women who are lactating
• Have donated blood of more than 500 milliliters (mL) within the last month prior to screening
• Have an average weekly alcohol intake that exceeds 21 units per week (men) and 14 units per week (women) (1 unit = 12 ounces \[oz\] or 360 mL of beer, 5 oz or 150 mL of wine, or 1.5 oz or 45 mL of distilled spirits)
• Are unwilling to stop alcohol consumption for the duration of the study (from screening until the follow-up visit)
• Are participants who smoke more than 10 cigarettes per day, are unwilling to refrain from smoking on the day of LY2189265 administration, or are unable to abide by clinical research unit (CRU) restrictions on other inpatient days

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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.

Munich, 81241, Germany

Location

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.

Budapest, 1032, Hungary

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

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

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 3, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 7, 2014
• Results First Posted: October 7, 2014

Record last verified: 2014-10

Locations

DE (1); HU (1)