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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Not changed optimal guideline directed therapy in the last 1 month prior to screening
Males in agreement to follow contraceptive requirements, or women of non-child-bearing potential
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through day 90
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and how well it works in people with heart failure.
Who is the study for?
This trial is for men willing to follow contraceptive guidelines or women not of childbearing potential, with chronic heart failure (NYHA II/III) and a left ventricular ejection fraction under 40%. Participants must have stable heart failure medication doses and meet specific blood test criteria. Exclusions include recent major cardiovascular events, certain valve diseases, liver/biliary disorders, lack of cancer screening, and some other cardiac conditions.Check my eligibility
What is being tested?
The study tests the safety and tolerability of LY3461767 in patients with chronic heart failure with reduced ejection fraction (HFrEF). It involves continuous subcutaneous infusion over several days. The drug's levels in the blood will be monitored to see how quickly it's eliminated from the body.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be closely monitored for any adverse reactions related to LY3461767 during its continuous infusion treatment for heart failure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't changed my cancer treatment plan in the last month.
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I agree to use contraception or am not able to have children.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through day 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through day 90
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Secondary outcome measures
PK: Maximum Concentration (Cmax) of LY3461767
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3461767
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3461767Experimental Treatment1 Intervention
LY3461767 administered subcutaneously (SC).
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered subcutaneously (SC).
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,618 Previous Clinical Trials
3,201,510 Total Patients Enrolled
13 Trials studying Heart Failure
20,356 Patients Enrolled for Heart Failure
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,704 Total Patients Enrolled
2 Trials studying Heart Failure
1,132 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I needed strong water pills through an IV for heart failure in the last 3 months.I have a heart condition like amyloidosis or muscular dystrophy.I have been on heart failure treatment for 6 months and my condition is moderately severe.Your body mass index (BMI) is 45 or lower.I have a history of cancer or currently have cancer.I haven't changed my cancer treatment plan in the last month.My dose for water pills has been the same for the last 2 weeks.I agree to use contraception or am not able to have children.I have moderate-to-severe narrowing or leakage in my heart valves.I have had liver, pancreas, or bile duct problems.I haven't had a heart attack, heart surgery, or stroke in the last 3 months.Your heart's pumping ability is less than 40%.You have had a high NT-ProBNP or BNP value in the past 12 months.
Research Study Groups:
This trial has the following groups:- Group 1: LY3461767
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to join this research protocol?
"Eligibility requirements for this trial mandates that applicants are between 18-80 years of age and have a diagnosis of heart failure. Around 50 patients will be accepted into the study."
Answered by AI
Are participants over 45 years old eligible for this research trial?
"Eligibility requirements for this clinical trial state that participants must be between 18 and 80 years old. Separately, there are 22 trials available to minors and 690 for seniors over 65."
Answered by AI
Are there still opportunities for individuals to enroll in this research endeavor?
"Correct. As per the clinicaltrials.gov records, this medical study is currently recruiting patients. The trial was first initiated on June 1st 2021 and recently updated as of July 18th 2022; 50 individuals will be needed from 4 different sites for participation in the experiment."
Answered by AI
How many locations are hosting this clinical investigation?
"This research endeavor is being conducted at four separate sites, such as Sentara Healthcare in Norfolk and the Henry Ford Hospital in Detroit. Additionally, University of North carolina's Division of Cardiology in Chapel Hill has been included along with 4 other locations."
Answered by AI
What type of adverse reactions have been associated with LY3461767?
"Given the limited safety data and efficacy proof, our team at Power conservatively rated LY3461767 with a score of 1."
Answered by AI
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