A Multiple Dose Study of LY2541546 in Healthy Postmenopausal Women

Phase 1CompletedNCT01742091

Eli Lilly and Company59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

LY2541546 - SCDRUG

Administered SC

LY2541546 - IVDRUG

Administered IV

Placebo - SCDRUG

Administered SC

Placebo - IV

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (5)

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

Honolulu, Hawaii, United States

Outcomes

Primary Outcomes

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 AE from this study that results in one of the following outcomes: * death * initial or prolonged inpatient hospitalization * a life-threatening experience (that is, immediate risk of dying) * persistent or significant disability/incapacity * congenital anomaly/birth defect * is considered significant by the investigator for any other reason

Time frame: Day 1 through Day 141

Secondary Outcomes

Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, 0-tau) of LY2541546

Weekly AUC (AUC\[0-tau\]) during the first and last dosing interval for each participant receiving LY2541546 is reported.

Time frame: Day 1 through Day 141

Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85

A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²). The least squares (LS) mean was adjusted for baseline lumbar spine BMD and treatment group.

Time frame: Predose and Day 85

Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies

Time frame: Predose (Day 1) and Postdose (Day 29, 85 and 141)

Pharmacodynamics (PD): Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)

N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model. Least squares (LS) mean was adjusted for baseline P1NP, treatment group, time (i.e. study day), and interaction between treatment group and time.

Data from ClinicalTrials.gov

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