A Multiple Dose Study of LY2541546 in Healthy Postmenopausal Women

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

The purpose of this study is to assess the safety and side effects of multiple doses of LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin) and intravenously (directly into a vein). The study will also test how long it takes the study drug to get into the body, how long it takes the body to get rid of it, the overall effect of the study drug on the body, and whether antibodies to the study drug are formed.

Key facts

Study ID: NCT01742091
Run by: Eli Lilly and Company
People needed: 59
Starts: 2009-09-01
Expected to finish: 2010-03-01
Last updated by the study team: 2018-07-18

Who can join

Age: 45 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Healthy postmenopausal females, as determined by medical history and physical examination
Body mass index (BMI) at screening between 19.0 and 32.0 kilograms per square meter (kg/m\^2), inclusive
Acceptable clinical laboratory test results, blood pressure and heart rate
Have given written informed consent

You may not qualify if…

Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
Have received study treatment in any trial of an investigational osteoporosis treatment, including LY2561553 (parathyroid hormone receptor modulator), within 12 weeks of screening or 5 half-lives, whichever is longer
Known allergies to LY2541546, its constituents, or related compounds
Persons who have previously participated in this study or any other study of LY2541546
History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
History or presence of low platelet count, bleeding issues or family history of bleeding disorders
Paget's disease, parathyroid disease, or thyroid disease
Fracture of a long bone within 12 weeks of screening
Regular use of known drugs of abuse and/or positive findings on urinary drug screening
Evidence of human immunodeficiency virus (HIV), hepatitis C, hepatitis B and/or positive for anti-HIV antibodies, hepatitis C antibody, or hepatitis B surface antigen
Current use of therapies for osteoporosis or use of hormone replacement therapy (HRT) within the previous 12 months
Blood donation within the last month
Are unwilling or unable to maintain their normal pattern of alcohol, caffeine, smoking, and exercise from the start to the end of the study or to abide by the clinical research unit restrictions. Note: Average weekly alcohol intake must not exceed 14 units per week
Are unable or unwilling to refrain from nicotine usage during Clinical Research Unit (CRU) confinement

Where it is running

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. — Daytona Beach, Florida, United States
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. — Honolulu, Hawaii, United States
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. — Evansville, Indiana, United States
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. — Austin, Texas, United States
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. — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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