A Study of the Effect of LY2189265 on Two Blood Pressure Drugs

What Was Tested

This registered phase 1 trial tested Dulaglutide for low blood pressure and orthostatic hypotension.

The purpose of this study is twofold: 1.

To evaluate the effect of LY2189265 on how the body absorbs a blood pressure lowering drug (lisinopril) in participants with high blood pressure who are currently taking lisinopril. 2.

To evaluate the effect of LY2189265 on heart rate and blood pressure in healthy volunteers when taken with a Beta-blocker drug (metoprolol).

It had four arms (groups): LY2189265 + Lisinopril (experimental), Placebo + Lisinopril (placebo comparator), LY2189265 (Treatment 1)/Metoprolol + LY2189265 (Treatment 2) (experimental) and Metoprolol + LY2189265 (Treatment 2)/LY2189265 (Treatment 1) (experimental).

The registry classes the interventions as biological and drug.

Who Took Part

51 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Female participants: women not of child-bearing potential due to menopause or surgical sterilization (at least 6 weeks post surgical bilateral oophorectomy, hysterectomy or tubal ligation) confirmed by medical history. Have a body mass index (BMI) of 18.5 to 40.0 kilograms/square meter (kg/m\^2), inclusive at the time of screening. Have venous access sufficient to allow for blood sampling as per the protocol. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study restrictions.

The full record lists 13 inclusion and 19 exclusion criteria; among the exclusions: have known allergies to glucagon-like peptide-1 (glp-1)-related compounds, including ly2189265, or any components of the formulation; have personal or family history of medullary thyroid cancer (mtc) or a genetic condition that predisposes to mtc; regularly use known drugs of abuse and/or show positive findings on urinary drug screening.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The low blood pressure and orthostatic hypotension participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the low blood pressure and orthostatic hypotension participants stayed in one arm throughout.

In this single-blind Dulaglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2011-03 with completion listed for 2011-08.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol (time frame: Day -1, Day 4, Day 7 of Treatment 2 in Part 2). Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol (time frame: Day -1, Day 4, Day 7 of Treatment 2 in Part 2).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Dulaglutide in 51 people with low blood pressure and orthostatic hypotension.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Dulaglutide compound page, Low blood pressure and orthostatic hypotension research.