A Study of LY3322207 in Healthy Participants and in Participants With Hypertension (High Blood Pressure)

February 22, 2019 updated by: Eli Lilly and Company

A Safety, Tolerability, and Pharmacokinetic Study of Single and Multiple Ascending Doses of LY3322207 in Healthy Subjects and Subjects With Hypertension on ACE I/ARB Therapy

The purpose of this study is to investigate the safety of the study drug known as LY3322207. Participants must be healthy or must have hypertension (high blood pressure). Participants with hypertension may already be taking a common drug to reduce blood pressure called an angiotensin-converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9728 NZ
        • PRA Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males, as determined by medical history and physical examination, must agree to use a medically appropriate method of birth control and agree not to donate sperm from start of dosing until 90 days beyond last dose

  • Healthy females, as determined by medical history and physical examination, of non-child bearing potential due to:

    • Menopause: spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications that induced the amenorrhea (for example: oral contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy)
    • Surgical sterilization
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow site specific study procedures
  • Have a Body Mass Index (BMI) 18 to 30 kilogram per square meter (kg/m²) at entry
  • Have clinical laboratory test results within normal reference range for the population or site, or results with acceptable deviations that are judged not clinically significant
  • Be 18 to 55 years old for either Part A or Part B of the study, or 18 to 65 years old for Part C only
  • For Part C: must have been treated with a stable dose of ACE-I or ARB for at least 1 month

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational drug that has not received regulatory approval
  • Have previously completed or withdrawn from this study or any other study investigating this study drug
  • Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, significant atopy, or any clinically significant laboratory abnormality that would preclude study participation
  • Have abnormality in the 12-lead electrocardiogram (ECG) which increases study risk
  • Have confirmed QT interval corrected by Bazett's method (QTcB) or Fridericia's (QTcF) method >450 millisecond (msec) for men and >470 msec for women
  • Have prior Q-wave myocardial infarction or other, specific heart abnormalities, arrhythmias or fibrillations
  • Have an abnormal blood pressure (supine) defined as diastolic blood pressure greater than (>)95 or less than (<)50 millimeters of mercury (mmHg) and/or systolic blood pressure >160 or <90 mmHg
  • Show evidence of human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
  • Have donated blood of more than 100 mL (milliliters) within the last month
  • Are unwilling to stop alcohol consumption while resident in the Clinical Research Unit
  • Have an average weekly alcohol intake that exceeds 21 units per week (1 unit equal to (=) 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
  • Have an abnormal blood pressure (supine) defined as diastolic blood pressure >95 or <50 mmHg and/or systolic blood pressure >160 or <90 mmHg
  • Have serum potassium outside normal range
  • Have had lymphoma, leukemia, or any malignancy within the past 5 years
  • Have clinically significant multiple or severe drug allergies or intolerance
  • Are lactating women
  • Positive findings for known drugs of abuse
  • Have received treatment with biologic agents within 3 months or 5 half-lives prior to dosing
  • Participation in any other clinical trial involving a study drug or off-label use of a drug or device, or any other type of medical research judged not to be compatible with this study
  • Have estimated glomerular filtration rate (eGFR) < 60 milliliters per minute per 1.73 square meter (mL/min/1.73 m²) for Parts A and B of this study, or eGFR < 50 mL/min/1.73 m² in Part C only
  • For Part C: have a history of severe hypertension (defined as SBP greater than or equal to (≥)180 mmHg and/or DBP ≥120 mmHg), secondary hypertension, symptomatic postural hypotension, or hospitalization due to hypertension
  • For Part C: have a history of supraventricular tachycardia (for example, atrial fibrillation), ventricular tachycardia, or other cardiac arrhythmia
  • For Part C: have resting tachycardia (heart rate ≥100 beats per minute)
  • For Part C: have New York Heart Association (NYHA) Class II, III, or IV heart failure, or had any of the following in the previous 3 months: coronary angioplasty, coronary stent placement, coronary bypass surgery or any significant cardiac surgery, myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack
  • For Part C: have an automatic internal cardioverter-defibrillator
  • For Part C: have diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LY3322207 (Part A)
LY3322207 administered subcutaneously (SC)
Drug: LY3322207
Administered by SC injection
Placebo Comparator: Placebo (Part A)
Placebo matching LY3322207 administered SC
Drug: Placebo
Administered by SC injection
Experimental: LY3322207 (Part B)
LY3322207 administered SC once weekly
Drug: LY3322207
Administered by SC injection
Placebo Comparator: Placebo (Part B)
Placebo matching LY3322207 administered SC once weekly
Drug: Placebo
Administered by SC injection
Experimental: LY3322207 (Part C)
LY3322207 administered SC in participants with hypertension
Drug: LY3322207
Administered by SC injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with One or More Serious Adverse Events (Part A)
Time Frame: Baseline up to approximately 31 days
Serious and other non-serious adverse events will be reported in the Adverse Events Module
Baseline up to approximately 31 days
Number of Participants with One or More Serious Adverse Events (Part B)
Time Frame: Baseline up to approximately 9 weeks
Serious and other non-serious adverse events will be reported in the Adverse Events Module
Baseline up to approximately 9 weeks
Number of Participants with One or More Serious Adverse Events (Part C)
Time Frame: Baseline up to approximately 9 weeks
Serious and other non-serious adverse events will be reported in the Adverse Events Module
Baseline up to approximately 9 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part A)
Time Frame: Predose up approximately 31 days
Pharmacokinetics (PK): AUC of LY3322207
Predose up approximately 31 days
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part B)
Time Frame: Predose up to approximately 9 weeks
PK: AUC of LY3322207
Predose up to approximately 9 weeks
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part C)
Time Frame: Predose up to approximately 9 weeks
PK: AUC of LY3322207
Predose up to approximately 9 weeks
Maximum Concentration (Cmax) of LY3322207 (Part A)
Time Frame: Predose up approximately 31 days
PK: Cmax of LY3322207
Predose up approximately 31 days
Maximum Concentration (Cmax) of LY3322207 (Part B)
Time Frame: Predose up to approximately 9 weeks
PK: Cmax of LY3322207
Predose up to approximately 9 weeks
Maximum Concentration (Cmax) of LY3322207 (Part C)
Time Frame: Predose up to approximately 9 weeks
PK: Cmax of LY3322207
Predose up to approximately 9 weeks
Time to reach Cmax (Tmax) of LY3322207 (Part A)
Time Frame: Predose up to approximately Day 31
PK: Tmax of LY3322207
Predose up to approximately Day 31
Time to reach Cmax (Tmax) of LY3322207 (Part B)
Time Frame: Predose up to approximately 9 weeks
PK: Tmax of LY3322207
Predose up to approximately 9 weeks
Time to reach Cmax (Tmax) of LY3322207 (Part C)
Time Frame: Predose up to approximately 9 weeks
PK: Tmax of LY3322207
Predose up to approximately 9 weeks
Change from Baseline in Systolic Blood Pressure (SBP) (Part A)
Time Frame: Baseline up approximately 31 days
Supine position
Baseline up approximately 31 days
Change from Baseline in Systolic Blood Pressure (SBP) (Part B)
Time Frame: Baseline up to approximately 9 weeks
Supine position
Baseline up to approximately 9 weeks
Change from Baseline in Systolic Blood Pressure (SBP) (Part C)
Time Frame: Baseline up to approximately 9 weeks
Supine position
Baseline up to approximately 9 weeks
Change from Baseline in Diastolic Blood Pressure (DBP) (Part A)
Time Frame: Baseline up approximately 31 days
Supine position
Baseline up approximately 31 days
Change from Baseline in Diastolic Blood Pressure (DBP) (Part B)
Time Frame: Baseline up to approximately 9 weeks
Supine position
Baseline up to approximately 9 weeks
Change from Baseline in Diastolic Blood Pressure (DBP) (Part C)
Time Frame: Baseline up to approximately 9 weeks
Supine position
Baseline up to approximately 9 weeks
Change from Baseline in Heart Rate (Part A)
Time Frame: Baseline up approximately 31 days
Supine position
Baseline up approximately 31 days
Change from Baseline in Heart Rate (Part B)
Time Frame: Baseline up to approximately 9 weeks
Supine position
Baseline up to approximately 9 weeks
Change from Baseline in Heart Rate (Part C)
Time Frame: Baseline up to approximately 9 weeks
Supine position
Baseline up to approximately 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16771
  • I9K-MC-UCAA (Other Identifier: Eli Lilly and Company)
  • 2018-002337-38 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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