A Single Dose Study of LY2605541 in Participants With Liver Impairment

NCT01751399 | Completed Phase 1 Results

• 2 other identifiers: 14205I2R-MC-BIDA
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 2

Brief Summary

The primary purpose of this study is to help answer the following research questions:

• To evaluate how much of the study drug (LY2605541) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function
• To assess the safety of LY2605541 and any side effects that might be associated with it

Conditions

Healthy Volunteers; Hepatic Insufficiency; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541

  Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose

• Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541

  Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose

Study Arms (4)

LY2605541-Normal Hepatic Function

EXPERIMENTAL

Participants with normal hepatic function will receive a single subcutaneous (SC) dose of 0.075 milligrams per kilogram (mg/kg) LY2605541

Drug: LY2605541

LY2605541-Mild Hepatic Impairment

EXPERIMENTAL

Participants with mild hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541

Drug: LY2605541

LY2605541-Moderate Hepatic Impairment

EXPERIMENTAL

Participants with moderate hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541

Drug: LY2605541

LY2605541-Severe Hepatic Impairment

EXPERIMENTAL

Participants with severe hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541

Drug: LY2605541

Interventions

LY2605541 DRUG

LY2605541-Mild Hepatic Impairment; LY2605541-Moderate Hepatic Impairment; LY2605541-Normal Hepatic Function; LY2605541-Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Participants (including those with type 2 diabetes mellitus \[T2DM\] who are controlled by diet)
• Male participants agree to use a reliable method of birth control during the study
• Female participants of child-bearing potential (not surgically sterilized between menarche and menopause) must have a negative pregnancy test at the time of enrollment and must be using a reliable method of birth control
• Women of non-child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy with or without hysterectomy or at least 6 weeks after tubal ligation) confirmed by medical history, or menopause.
• Menopausal women include women with either spontaneous amenorrhea for at least 12 months or spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone (FSH) level greater than 40 milli international units per milliliter (mIU/mL)
• Have a body mass index (BMI) of 18.5 to 40 kilogram per square meter (kg/m\^2)
• Have normal sitting blood pressure and heart rate compatible with their disease state
• Have venous access sufficient to allow blood sampling
• Have given written informed consent approved by Lilly and the Ethical Review Board (ERB) governing the site
• Participants with Normal Hepatic Function
• Overtly healthy males or females with normal hepatic function
• 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
• Participants with Hepatic Impairment
• Have stable liver impairment with no sign of recent deterioration (alcoholic, posthepatitis, biliary cirrhosis, or cryptogenic) classified as Child-Pugh class A, B, or C who are considered by the investigator as acceptable for participation in the study

You may not qualify if:

• All Participants (including those with T2DM)
• Are currently enrolled in, have completed or discontinued within the last 30 days from a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• Have an acute infection with fever or infectious disease or febrile illness within 3 days prior to administration of the study medication
• Have known allergies or significant hypersensitivity to LY2605541, its excipients, or related compounds, or history of relevant allergic reactions of any origin
• Have previously completed or withdrawn from this study or any other study investigating LY2605541 and have previously received the investigational product
• Have Type 1 Diabetes Mellitus (T1DM) or have T2DM and are receiving anti-diabetic medication
• 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
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies
• Have donated blood of more than 500 milliliters (mL) within the last month
• Have had a liver transplant or have taken immunosuppressants following any organ transplant
• Have shown signs of variceal bleeding during the last 2 weeks prior to screening
• Show evidence of irritable bowel syndrome, chronic diarrhea, other symptomatic digestive problems or a known history of repeated chronic stool positive for occult blood, or be considered by the investigator to be at greater risk of acute or chronic pancreatitis
• Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 ounces \[oz\] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
• Are on total parenteral nutrition

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.

Balatonfüred, 8230, Hungary

Location

MeSH Terms

Conditions

Hepatic Insufficiency; Diabetes Mellitus, Type 2

Interventions

LY2605541

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 18, 2012
• Study Start: December 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 19, 2018
• Results First Posted: October 19, 2018

Record last verified: 2018-03

Locations

DE (1); HU (1)