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HypertensionPhase 1NCT03590860

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

A Phase 1 study testing LY3322207 in people with Hypertension, run by Eli Lilly and Company at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
LY3322207
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteNetherlands
Study dates
13 Jul 2018to 17 Jan 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • PRA Health Sciences

    Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: 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).

Conditions
Hypertension
Being tested
LY3322207, Placebo
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3322207Drug

    Administered by SC injection

  • PlaceboDrug

    Administered by SC injection

Study groups in NCT03590860
Study groupRoleWhat they receive
LY3322207 (Part A)ExperimentalLY3322207 administered subcutaneously (SC)
Receives: Drug: LY3322207
Placebo (Part A)Placebo comparatorPlacebo matching LY3322207 administered SC
Receives: Drug: Placebo
LY3322207 (Part B)ExperimentalLY3322207 administered SC once weekly
Receives: Drug: LY3322207
Placebo (Part B)Placebo comparatorPlacebo matching LY3322207 administered SC once weekly
Receives: Drug: Placebo
LY3322207 (Part C)ExperimentalLY3322207 administered SC in participants with hypertension
Receives: Drug: LY3322207

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with One or More Serious Adverse Events (Part A)

    Serious and other non-serious adverse events will be reported in the Adverse Events Module

    Measured: Baseline up to approximately 31 days

  2. Number of Participants with One or More Serious Adverse Events (Part B)

    Serious and other non-serious adverse events will be reported in the Adverse Events Module

    Measured: Baseline up to approximately 9 weeks

  3. Number of Participants with One or More Serious Adverse Events (Part C)

    Serious and other non-serious adverse events will be reported in the Adverse Events Module

    Measured: Baseline up to approximately 9 weeks

Secondary outcomes (18)

  1. Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part A)

    Pharmacokinetics (PK): AUC of LY3322207

    Measured: Predose up approximately 31 days

  2. Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part B)

    PK: AUC of LY3322207

    Measured: Predose up to approximately 9 weeks

  3. Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part C)

    PK: AUC of LY3322207

    Measured: Predose up to approximately 9 weeks

  4. Maximum Concentration (Cmax) of LY3322207 (Part A)

    PK: Cmax of LY3322207

    Measured: Predose up approximately 31 days

  5. Maximum Concentration (Cmax) of LY3322207 (Part B)

    PK: Cmax of LY3322207

    Measured: Predose up to approximately 9 weeks

  6. Maximum Concentration (Cmax) of LY3322207 (Part C)

    PK: Cmax of LY3322207

    Measured: Predose up to approximately 9 weeks

  7. Time to reach Cmax (Tmax) of LY3322207 (Part A)

    PK: Tmax of LY3322207

    Measured: Predose up to approximately Day 31

  8. Time to reach Cmax (Tmax) of LY3322207 (Part B)

    PK: Tmax of LY3322207

    Measured: Predose up to approximately 9 weeks

  9. Time to reach Cmax (Tmax) of LY3322207 (Part C)

    PK: Tmax of LY3322207

    Measured: Predose up to approximately 9 weeks

  10. Change from Baseline in Systolic Blood Pressure (SBP) (Part A)

    Supine position

    Measured: Baseline up approximately 31 days

  11. Change from Baseline in Systolic Blood Pressure (SBP) (Part B)

    Supine position

    Measured: Baseline up to approximately 9 weeks

  12. Change from Baseline in Systolic Blood Pressure (SBP) (Part C)

    Supine position

    Measured: Baseline up to approximately 9 weeks

  13. Change from Baseline in Diastolic Blood Pressure (DBP) (Part A)

    Supine position

    Measured: Baseline up approximately 31 days

  14. Change from Baseline in Diastolic Blood Pressure (DBP) (Part B)

    Supine position

    Measured: Baseline up to approximately 9 weeks

  15. Change from Baseline in Diastolic Blood Pressure (DBP) (Part C)

    Supine position

    Measured: Baseline up to approximately 9 weeks

  16. Change from Baseline in Heart Rate (Part A)

    Supine position

    Measured: Baseline up approximately 31 days

  17. Change from Baseline in Heart Rate (Part B)

    Supine position

    Measured: Baseline up to approximately 9 weeks

  18. Change from Baseline in Heart Rate (Part C)

    Supine position

    Measured: Baseline up to approximately 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2018
  2. Study start13 Jul 2018
  3. Primary completion17 Jan 2019
  4. Study completion17 Jan 2019

Why it stopped: injection site reaction burden

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03590860
Sponsor's protocol ID
16771
Other IDs
I9K-MC-UCAA, 2018-002337-38, 2018
Status last verified
Feb 2019
First submitted
6 Jul 2018
Last updated
25 Feb 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3322207 in people with Hypertension, run by Eli Lilly and Company at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: injection site reaction burden). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with One or More Serious Adverse Events (Part A) (time frame: Baseline up to approximately 31 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03590860.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.

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