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

NCT03590860 | Terminated Phase 1 FDA Drug

• 3 other identifiers: 16771I9K-MC-UCAA2018-002337-38
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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 (ACE-I) or an angiotensin II receptor blocker (ARB).

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• 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

  Baseline up to approximately 31 days

• 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

  Baseline up to approximately 9 weeks

• 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

  Baseline up to approximately 9 weeks

Secondary Outcomes (18)

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

  Predose up approximately 31 days

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

  Predose up to approximately 9 weeks

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

  Predose up to approximately 9 weeks

• Maximum Concentration (Cmax) of LY3322207 (Part A)

  Predose up approximately 31 days

• Maximum Concentration (Cmax) of LY3322207 (Part B)

  Predose up to approximately 9 weeks

Study Arms (5)

LY3322207 (Part A)

EXPERIMENTAL

LY3322207 administered subcutaneously (SC)

Drug: LY3322207

Placebo (Part A)

PLACEBO COMPARATOR

Placebo matching LY3322207 administered SC

Drug: Placebo

LY3322207 (Part B)

EXPERIMENTAL

LY3322207 administered SC once weekly

Drug: LY3322207

Placebo (Part B)

PLACEBO COMPARATOR

Placebo matching LY3322207 administered SC once weekly

Drug: Placebo

LY3322207 (Part C)

EXPERIMENTAL

LY3322207 administered SC in participants with hypertension

Drug: LY3322207

Interventions

LY3322207 DRUG

Administered by SC injection

LY3322207 (Part A); LY3322207 (Part B); LY3322207 (Part C)

Placebo DRUG

Administered by SC injection

Placebo (Part A); Placebo (Part B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

PRA Health Sciences

Groningen, 9728 NZ, Netherlands

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part C will be open label
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 18, 2018
• Study Start: July 13, 2018
• Primary Completion: January 17, 2019
• Study Completion: January 17, 2019
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

NL (1)