90 Participants NeededMy employer runs this trial

LY3971297 for Heart Failure

Recruiting at 16 trial locations
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Pi
Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company
Must be taking: Vasodilators

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how well the new treatment, LY3971297, is tolerated by individuals with heart failure. It targets two types of heart failure: HFpEF, where the heart pumps normally but still doesn't function well, and HFrEF, where the heart doesn't pump as strongly as it should. The trial will compare the effects of the drug and a placebo (inactive substance) across different groups. Ideal participants have experienced stable heart failure symptoms and have been on consistent heart failure medication for at least six months. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you have been on a stable dose of your heart failure medications for at least 4 weeks before screening and that you do not plan to change your medications during the study. You must also avoid starting any new prescription or nonprescription drugs during the trial.

Is there any evidence suggesting that LY3971297 is likely to be safe for humans?

Research has shown that LY3971297 has been tested in both healthy individuals and those with obesity to assess its tolerability. Earlier studies examined the drug's side effects when administered as an injection under the skin. Results indicated that LY3971297 was generally well-tolerated, with most side effects being mild, such as minor reactions at the injection site.

As this current trial is in the early phase, it primarily focuses on safety and identifying any possible side effects. Although LY3971297 has been safe for some individuals, it is still under close monitoring to ensure its safety for those with heart failure.12345

Why do researchers think this study treatment might be promising for heart failure?

Unlike the standard treatments for heart failure, which typically include medications like ACE inhibitors, beta-blockers, and diuretics, LY3971297 offers a unique approach. Researchers are excited about LY3971297 because it is administered either subcutaneously (SC) or intravenously (IV), which could offer flexibility and convenience in its delivery method. Additionally, LY3971297 might feature a novel mechanism of action targeting pathways not addressed by existing medications, potentially leading to improved outcomes for patients with heart failure. These features make LY3971297 a promising candidate for addressing unmet needs in heart failure treatment.

What evidence suggests that LY3971297 might be an effective treatment for heart failure?

Research has shown that LY3971297 mimics a natural hormone that helps lower blood pressure and may improve heart health. Although limited information exists on its effectiveness for heart failure in people, its mechanism suggests it could help manage heart-related symptoms. Early studies in healthy and overweight individuals are examining its safety and how the body processes the drug. This trial will evaluate LY3971297 in various treatment arms to further explore its potential for treating heart failure. More research is needed to confirm its effectiveness.12345

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with chronic heart failure (either preserved or reduced ejection fraction) who are on stable heart failure medications, have controlled blood pressure, and meet specific heart function criteria. People with recent major heart events, severe valve disease, certain device implants, or unstable health conditions cannot join.

Inclusion Criteria

Have a body mass index within the range of 18.5 to 40 kg/m²
I have chronic heart failure with moderate symptoms and have been on treatment for 6 months.
I was hospitalized for heart failure between 30 days and 12 months ago.
See 8 more

Exclusion Criteria

I have heart failure and am listed for a transplant or recently had certain heart devices placed.
Have resting heart rate >90 bpm at screening
For US sites: have donated blood of more than 500 mL within the previous 90 days of screening or intend to donate blood during the course of the study
See 25 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of LY3971297 or placebo, with blood tests to assess drug processing and effects

4 days (inpatient) + 5 outpatient visits
1 inpatient visit (4 days), 5 outpatient visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY3971297

Trial Overview

The study tests a new drug called LY3971297 compared to a placebo in people with two types of heart failure. Participants are randomly assigned to receive either the drug or placebo over about 2 months, including both inpatient and outpatient visits.

How Is the Trial Designed?

12

Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3971297 Part BExperimental Treatment1 Intervention
Group II: LY3971297 Part A Cohort 5Experimental Treatment1 Intervention
Group III: LY3971297 Part A Cohort 4Experimental Treatment1 Intervention
Group IV: LY3971297 Part A Cohort 3Experimental Treatment1 Intervention
Group V: LY3971297 Part A Cohort 2Experimental Treatment1 Intervention
Group VI: LY3971297 Part A Cohort 1Experimental Treatment1 Intervention
Group VII: Placebo Part A Cohort 2Placebo Group1 Intervention
Group VIII: Placebo Part A Cohort 4Placebo Group1 Intervention
Group IX: Placebo Part BPlacebo Group1 Intervention
Group X: Placebo Part A Cohort 3Placebo Group1 Intervention
Group XI: Placebo Part A Cohort 1Placebo Group1 Intervention
Group XII: Placebo Part A Cohort 5Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

A Study of LY3971297 in Participants With Heart Failure

The main purpose of this study is to assess how well LY3971297 is tolerated and what side effects may occur in participants with heart ...

LY-3971297 by Eli Lilly and Co for Congestive Heart ...

LY-3971297 is under development for the treatment of heart failure, obesity and hypertension. The drug candidate is administered through subcutaneous route.

A Study of LY3971297 in Healthy Participants and ... - Lilly Trials

The purpose of this study is to measure side effects of LY3971297 injection administered under the skin in healthy participants and obese participants with ...

A Study of LY3971297 in Healthy Participants

The purpose of this study is to measure side effects of LY3971297 injection administered under the skin in healthy participants and obese participants with ...

LY3971297 for Obesity · Recruiting Participants for Phase ...

This trial tests a new treatment, LY3971297 (a long-acting atrial natriuretic peptide), to understand its side effects and behavior in the body.