CClinicalTrials.gg
Sign In
CompletedNCT02194465Updated Jun 26, 2020Results posted

A Study of LY2623091 in Participants With High Blood Pressure

A Phase 2 interventional study of LY2623091 and Tadalafil in Primary Hypertension, sponsored by Eli Lilly and Company. Completed at 43 sites in 3 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-06-26.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
304
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as LY2623091 in participants with high blood pressure.

02

Conditions studied

  • Primary Hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 304 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Have a history of hypertension.

  • If participants are naïve to treatment of hypertension, or have not been treated with any antihypertensive medications within the 30 days immediately prior to screening:

    • Have seated systolic (SBP) of ≥140 and \<170 millimeters of mercury (mmHg) at screening and at the end of the lead-in period.

  • If participants are currently being treated for hypertension:

    • Are taking a stable dose of 1 or 2 antihypertensive medications for at least the previous 30 days. A combination antihypertensive medication from 2 classes is considered as 2 antihypertensive medications.
    • Are willing to discontinue the antihypertensive medications during the study.
    • Have seated SBP of ≥140 and \<170 mmHg at the end of the lead-in period.
  • Have a body mass index (BMI) ≥18.5 and \<40 kilograms/m\^2.

Exclusion criteria

Exclusion Criteria:

  • Have a history of severe hypertension (defined as SBP ≥180 mmHg and/or diastolic (DBP) ≥120 mmHg), secondary hypertension, symptomatic postural hypotension, or hospitalization due to hypertension.
  • Have SBP ≥180 mmHg and/or DBP ≥110 mmHg at screening, lead-in period, or randomization.
  • Have a history of hospitalization due to hyperkalemia, or history of drug discontinuation due to elevated serum potassium levels.
  • Have a serum potassium ≤3.5 or >5.0 millimoles per liter (mmol/L).
  • Have an estimated glomerular filtration rate (eGFR) \<50 milliliters/minute/1.73 m\^2.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
304 participants (actual)

Study arms

  • Experimental
    6 milligrams (mg) LY2623091

    6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.

    Drug: LY2623091 · Drug: Placebo

  • Experimental
    13 mg LY2623091

    13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.

    Drug: LY2623091 · Drug: Placebo

  • Experimental
    24.5 mg LY2623091

    24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.

    Drug: LY2623091 · Drug: Placebo

  • Experimental
    13 mg LY2623091 + 20 mg tadalafil

    13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.

    Drug: LY2623091 · Drug: Tadalafil · Drug: Placebo

  • Experimental
    20 mg tadalafil

    20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.

    Drug: Tadalafil · Drug: Placebo

  • Active comparator
    Spironolactone

    25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.

    Drug: Spironolactone

  • Placebo comparator
    Placebo

    Placebo for blinding administered orally once daily for 4 weeks.

    Drug: Placebo

Interventions

  • DrugLY2623091

    Administered orally

    Also known as: Mineralocorticoid Receptor Antagonist

  • DrugTadalafil

    Administered orally

    Also known as: LY450190

  • DrugSpironolactone

    Administered orally

  • DrugPlacebo

    Administered orally

06

What researchers measure

Primary outcomes

  1. Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)

    Change from baseline in SBP as measured by a cuff. Least squares (LS) mean change from baseline was calculated using a mixed model repeating measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.

    Time frame: Baseline, 4 Weeks

Secondary outcomes

  1. Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)

    Change from baseline in DBP as measured by a cuff. LS mean change from baseline was calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.

    Time frame: Baseline, 4 Weeks

  2. Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)

    The LS mean change in blood pressure is calculated after adjusting for baseline, treatment and race using an analysis of covariance (ANCOVA).

    Time frame: Baseline, 4 Weeks

  3. Change From Baseline to 4 Weeks in Serum Potassium

    Potassium measurement as measured by standard laboratory tests. The LS mean change in potassium is calculated using MMRM with adjustment for baseline, treatment, visit, treatment\*visit and race.

    Time frame: Baseline, 4 Weeks

  4. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091

    Time frame: 2 hours post-dose at 4 Weeks

07

Results

Posted Jun 26, 2020

Participant flow

Participant flow — Overall Study
MilestonePlacebo6 Milligrams (mg) LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactone
Started51505249512526
Received at least 1 dose of study drug51505149512526
Completed42434441422124
Not completed9788942
Withdrew: Adverse event6144420
Withdrew: Lost to follow-up0001010
Withdrew: Physician decision1000000
Withdrew: Protocol violation1121100
Withdrew: Withdrawal by subject1312212
Withdrew: Discontinued follow-up period0210200

Outcome measures

PrimaryChange From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)

Change from baseline in SBP as measured by a cuff. Least squares (LS) mean change from baseline was calculated using a mixed model repeating measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.

Time frame:
Baseline, 4 Weeks
Reported as:
Least squares mean · millimeter of mercury (mmHg)
Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)
millimeter of mercury (mmHg)Placebo6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactone
Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)-0.5 ± 11.6-13.1 ± 11.2-14.6 ± 12.3-14.3 ± 13.6-11.8 ± 12.5-7.1 ± 13.3-15.4 ± 11.7
SecondaryChange From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)

Change from baseline in DBP as measured by a cuff. LS mean change from baseline was calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.

Time frame:
Baseline, 4 Weeks
Reported as:
Least squares mean · mmHg
Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)
mmHgPlacebo6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactone
Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)0.5 ± 7.9-5.6 ± 9.2-4.8 ± 7.2-7.1 ± 7.6-6.8 ± 8.7-6.6 ± 8.7-1.2 ± 6.1
SecondaryChange From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)

The LS mean change in blood pressure is calculated after adjusting for baseline, treatment and race using an analysis of covariance (ANCOVA).

Time frame:
Baseline, 4 Weeks
Reported as:
Least squares mean · mmHg
Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)
mmHgPlacebo6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactone
SBP0.3 ± 11.3-4.9 ± 8.7-11.1 ± 8.9-10.4 ± 11.4-10.4 ± 11.6-6.3 ± 8.9-6.4 ± 6.8
DBP1.0 ± 7.7-1.7 ± 6.3-4.7 ± 6.1-3.4 ± 4.8-6.2 ± 8.0-5.6 ± 4.9-2.0 ± 4.6
SecondaryChange From Baseline to 4 Weeks in Serum Potassium

Potassium measurement as measured by standard laboratory tests. The LS mean change in potassium is calculated using MMRM with adjustment for baseline, treatment, visit, treatment\*visit and race.

Time frame:
Baseline, 4 Weeks
Reported as:
Least squares mean · millimoles/L (mmol/L)
Change From Baseline to 4 Weeks in Serum Potassium
millimoles/L (mmol/L)Placebo6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactone
Change From Baseline to 4 Weeks in Serum Potassium-0.04 ± 0.060.10 ± 0.060.11 ± 0.060.25 ± 0.060.10 ± 0.06-0.06 ± 0.080.30 ± 0.08
SecondaryPharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091
Time frame:
2 hours post-dose at 4 Weeks
Reported as:
Geometric mean · nanogram/milliliter (ng/ml)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091
nanogram/milliliter (ng/ml)6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091122 ± 32228 ± 37379 ± 51206 ± 53

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/51 (0%)23/51 (45.1%)
6 mg LY2623091—0/50 (0%)23/50 (46%)
13 mg LY2623091—2/51 (3.9%)21/51 (41.2%)
24.5 mg LY2623091—0/49 (0%)18/49 (36.7%)
13 mg LY2623091 + 20 mg Tadalafil—1/51 (2%)34/51 (66.7%)
20 mg Tadalafil—0/25 (0%)14/25 (56%)
Spironolactone—0/26 (0%)12/26 (46.2%)
Most frequent serious events
Most frequent serious events
EventPlacebo6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactone
Inguinal herniaGastrointestinal disorders0/510/500/510/491/510/250/26
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders0/510/501/510/490/510/250/26
Diabetic footSkin and subcutaneous tissue disorders0/510/501/510/490/510/250/26
Most frequent other events
Showing 10 of 119
Most frequent other events
EventPlacebo6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactone
HeadacheNervous system disorders3/515/502/511/4910/513/250/26
DyspepsiaGastrointestinal disorders0/510/501/511/491/512/250/26
NasopharyngitisInfections and infestations1/514/502/511/491/510/250/26
DizzinessNervous system disorders1/511/502/511/494/511/250/26
NauseaGastrointestinal disorders1/510/500/512/493/510/252/26
DiarrhoeaGastrointestinal disorders1/511/501/510/493/510/251/26
VomitingGastrointestinal disorders0/511/500/510/493/510/250/26
EpididymitisInfections and infestations0/350/330/270/290/301/170/19
ArthralgiaMusculoskeletal and connective tissue disorders1/510/500/510/493/510/250/26
InsomniaPsychiatric disorders0/510/500/510/493/510/250/26

Baseline characteristics

All randomized participants who received at least 1 dose of a study drug.

Age, Continuous
Age, Continuous(years)Placebo6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactoneTotal
Mean58.6 ± 9.456.6 ± 11.458.0 ± 8.858.7 ± 8.857.9 ± 9.554.0 ± 8.959.0 ± 11.057.7 ± 9.7
Sex: Female, Male
Sex: Female, Male(Participants)Placebo6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactoneTotal
Female161724202187113
Male35332729301719190
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactoneTotal
Hispanic or Latino252244120
Not Hispanic or Latino42394539431923250
Unknown or Not Reported764842233
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactoneTotal
American Indian or Alaska Native10121005
Asian742622326
Native Hawaiian or Other Pacific Islander00000000
Black or African American13151412137680
White28303429351516187
More than one race21000115
Unknown or Not Reported00000000
Region of Enrollment
Region of Enrollment(Participants)Placebo6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactoneTotal
Canada1812913135474
United States32364135381921222
Puerto Rico12110117
BMI
BMI(kilogram/square meter (kg/m2))Placebo6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactoneTotal
Mean30.5 ± 4.530.2 ± 5.230.2 ± 4.932.7 ± 4.529.5 ± 4.729.6 ± 4.231.4 ± 4.530.6 ± 4.8
Chronic Kidney Disease (CKD)
Chronic Kidney Disease (CKD)(Participants)Placebo6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactoneTotal
Y03200229
N51474949512324294
Anti-Hypertensive Medication
Anti-Hypertensive Medication(Participants)Placebo6 mg LY262309113 mg LY262309124.5 mg LY262309113 mg LY2623091 + 20 mg Tadalafil20 mg TadalafilSpironolactoneTotal
081057136352
124222522171010130
21917201920813116
301101104
400010001

3 further baseline measures are reported on the registry.

08

Study locations

43 sites
  • Clinical Research Advantage
    Glendale, Arizona 85306, United States
  • John Muir Health Network - The Osteoporosis Center
    Concord, California 94520, United States
  • Encompass Clinical Research
    Encinitas, California 92024, United States
  • Avail Clinical Research LLC
    DeLand, Florida 32720, United States
  • Alan Graff, MD, PA
    Fort Lauderdale, Florida 33308, United States
  • Jacksonville Center for Clinical Research
    Jacksonville, Florida 32216, United States
  • Cardiovascular Center of Sarasota
    Sarasota, Florida 34239, United States
  • East West Medical Institute
    Honolulu, Hawaii 96814, United States
  • Rocky Mountain Diabetes and Osteoporosis Center
    Idaho Falls, Idaho 83404, United States
  • Northwest Heart Clinical Research, LLC
    Arlington Heights, Illinois 60005, United States
  • Cedar-Crosse Research Center
    Chicago, Illinois 60607, United States
  • Midwest Institute for Clinical Research
    Indianapolis, Indiana 46260, United States
  • Community Clinical Research Center
    Muncie, Indiana 47304, United States
  • Heartland Research Associates
    Wichita, Kansas 67207, United States
  • Grace Research
    Bossier City, Louisiana 71111, United States
  • Maine Research Associates
    Auburn, Maine 04210, United States
  • AB Clinical Trials
    Las Vegas, Nevada 89119, United States
  • Rochester Clinical Research, Inc.
    Rochester, New York 14609, United States
  • Metrolina Internal Medicine, P.A.
    Charlotte, North Carolina 28204, United States
  • PharmQuest
    Greensboro, North Carolina 27408, United States
  • Lillestol Research LLC
    Fargo, North Dakota 58103, United States
  • Sterling Research Group, LTD
    Cincinnati, Ohio 45219, United States
  • Rapid Medical Research Inc
    Cleveland, Ohio 44122, United States
  • Columbus Clinical Research
    Columbus, Ohio 43213, United States
  • Dayton Clinical Research
    Dayton, Ohio 45406, United States
  • Cor Clinical Research LLC
    Oklahoma City, Oklahoma 4052728481, United States
  • Oklahoma Foundation For Cardiovascular Research
    Oklahoma City, Oklahoma 73120, United States
  • Mountain View Clinical Research, Inc
    Greer, South Carolina 29651, United States
  • Texas Diabetes and Endocrinology
    Austin, Texas 78731-4309, United States
  • Tekton Research, Inc
    Austin, Texas 78745, United States
  • Texas Diabetes and Endocrinology, P.A.
    Round Rock, Texas 78681, United States
  • Northwest Clinical Research Center
    Bellevue, Washington 98007-4209, United States
  • Universal Research Group, LLC
    Tacoma, Washington 98405, United States
  • 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.
    Brampton, L6T 0G1, Canada
  • 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.
    Kelowna, V1Y3G8, Canada
  • 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.
    Peterborough, K9J 0B2, Canada
  • 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.
    Pointe Claire, H9R 4S3, Canada
  • 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.
    Quebec City, G1N 4V3, Canada
  • 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.
    Red Deer, T4N 6V7, Canada
  • 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.
    Sherbrooke, J1J 2G2, Canada
  • 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.
    Toronto, M9W 4L6, Canada
  • Research and Cardiovascular Corp.
    Ponce, 00717-1322, Puerto Rico
  • Clinical Research Puerto Rico, Inc.
    San Juan, 00909, Puerto Rico
09

References and documents

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02194465
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jul 18, 2014
Start date
Aug 2014
Primary completion
Mar 2015
Completion
Mar 2015
Results posted
Jun 26, 2020
Last update
Jun 26, 2020

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypertension→

Other studies from this sponsor

Eli Lilly and Company

Start the discussion