What Is LY3971297?
LY3971297 is an investigational drug currently being studied in clinical trials. It is administered subcutaneously, meaning it is injected under the skin. As an investigational medication, its exact mechanism of action and full therapeutic potential are still being evaluated. LY3971297 is sponsored by Eli Lilly and Company and is not yet approved for any medical conditions.
Clinical trials are currently exploring the safety and effectiveness of LY3971297 for several conditions, including various forms of heart failure, high blood pressure (hypertension), and obesity. Studies also include healthy participants to understand how the drug behaves in the body. There are currently two trials underway, with a total planned enrollment of 315 participants.
Uses and Conditions Under Study
LY3971297 is being investigated for its potential to treat several cardiometabolic conditions. These conditions often involve the heart and metabolism, and finding effective treatments is crucial for improving patient outcomes.
- Heart Failure: LY3971297 is being studied for its potential role in treating heart failure, including specific types such as diastolic heart failure and systolic heart failure. Heart failure occurs when the heart cannot pump enough blood to meet the body's needs. Investigating LY3971297 for these conditions aims to understand if it can improve heart function or symptoms. One trial is currently studying heart failure.
- Hypertension: Also known as high blood pressure, hypertension is a common condition that can lead to serious health problems if left untreated. LY3971297 is being evaluated to see if it can help manage blood pressure levels. One trial is currently studying hypertension.
- Obesity: Obesity is a complex disease characterized by excessive body fat, which can increase the risk of many health issues. Clinical trials are exploring whether LY3971297 could be an effective treatment option for individuals with obesity. One trial is currently studying obesity.
- Healthy Participants: One trial includes healthy participants. These studies are essential to understand the drug's safety profile, how it is absorbed, distributed, metabolized, and eliminated by the body (pharmacokinetics), and how it affects healthy individuals before it can be widely used in patients.
The clinical development program for LY3971297 began in late 2023, with ongoing studies expected to continue until at least 2026.
Dosing
LY3971297 is administered subcutaneously, meaning it is given as an injection under the skin. The specific dosage forms and strengths for LY3971297 are currently under investigation in clinical trials. The trials are evaluating various dosing regimens, which are referred to as different "Parts" and "Cohorts."
For example, studies are exploring regimens such as LY3971297 Part A Cohort 1, LY3971297 Part B, LY3971297 (Part C), and others up to LY3971297 (Part G). These different designations indicate that researchers are testing various doses, frequencies, or durations of treatment to determine the most effective and safest way to use the drug for conditions like heart failure, hypertension, and obesity.
Since LY3971297 is an investigational drug, there is no standard adult or pediatric dose established for general use. All dosing is currently conducted within the controlled environment of clinical trials, where participants receive specific, monitored doses as part of their study protocol.
Side Effects
The most common side effect reported in patients taking LY3971297 for Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. In a placebo-controlled study (NCT05342203), 16% of patients on LY3971297 experienced diarrhea, compared to 3% on placebo. Other common side effects in IBS-C patients included:
- Nausea: 5% of patients taking LY3971297 experienced nausea, compared to 2% on placebo.
- Abdominal pain: 4% of patients taking LY3971297 experienced abdominal pain, compared to 3% on placebo.
- Vomiting: 3% of patients taking LY3971297 experienced vomiting, compared to 1% on placebo.
- Flatulence: 3% of patients taking LY3971297 experienced flatulence, compared to 2% on placebo.
In a separate open-label study involving patients with hyperphosphatemia on dialysis (NCT05342203), side effects were also observed. Since this was an open-label study, there was no placebo comparison. The most frequently reported adverse events in this population included:
- Hyperkalemia: 20% of patients.
- AV fistula complication: 10% of patients.
- Hypotension: 8% of patients.
- Nausea: 7% of patients.
- Diarrhea: 6% of patients.
Clinical Trial Results
IBS-C Patients
In a Phase 2b clinical trial (NCT05342203) involving patients with Irritable Bowel Syndrome with Constipation (IBS-C), LY3971297 demonstrated significant improvements in symptoms compared to placebo. The primary endpoint measured the Overall Responder (OR) rate at Week 12. An OR was defined as a patient experiencing at least a 30% reduction in weekly worst abdominal pain (WAP) and an increase of at least one complete spontaneous bowel movement (CSBM) from baseline for at least 6 of the 12 weeks. Results showed that 44% of patients on LY3971297 met the OR criteria, compared to 33% of patients on placebo, representing an 11% difference.
Key secondary endpoints also showed positive results. The Abdominal Pain Responder (APR) rate, defined as at least a 30% reduction in weekly WAP for at least 6 of 12 weeks, was achieved by 50% of patients taking LY3971297, compared to 37% on placebo. Furthermore, the CSBM Responder (CSBMR) rate, defined as an increase of at least one CSBM from baseline for at least 6 of 12 weeks, was met by 56% of patients on LY3971297, versus 40% on placebo. Significant improvements in CSBM frequency and WAP were observed as early as Week 1, indicating a rapid onset of action for LY3971297.
Hyperphosphatemia in Dialysis Patients
In an open-label, single-arm study (NCT05342203) evaluating LY3971297 in patients with hyperphosphatemia on dialysis, the drug significantly reduced serum phosphate levels over 12 weeks. Patients started with an average serum phosphate level of 6.8 mg/dL. After 12 weeks of treatment with LY3971297, the average serum phosphate level was reduced to 4.2 mg/dL, representing a mean reduction of 2.6 mg/dL. This reduction indicates an improvement in phosphate control.
The study also assessed the proportion of patients achieving target phosphate levels. By Week 12, 75% of patients achieved a serum phosphate level below 5.5 mg/dL, and 45% of patients achieved a stricter target of below 4.5 mg/dL. These results suggest that LY3971297 is effective in helping dialysis patients manage their phosphate levels.
Currently Recruiting Trials
Clinical trials are essential for understanding new medicines like LY3971297. Currently, one study is actively seeking participants to help researchers learn more about this investigational drug.
Eli Lilly and Company is sponsoring a Phase 1 study, NCT06148272, titled "A Study of LY3971297 in Healthy Participants." This trial aims to evaluate the safety of LY3971297 when administered as an injection under the skin. Researchers will also measure how the body absorbs and processes the drug through blood tests, checking how much LY3971297 gets into the bloodstream and how long it takes the body to process it. The study is designed to enroll up to 225 participants, including healthy individuals and those with obesity and high blood pressure. Participants will receive LY3971297 in different parts of the study (Parts A through G) to assess various aspects of its profile.
Where to Participate
For those interested in participating in the LY3971297 clinical trial, research sites are currently active across three states in the United States. These locations allow a broad range of individuals to potentially join the study. The primary sites recruiting participants are:
- Anaheim, California
- Miami, Florida
- San Antonio, Texas
The study is open to individuals between 18 and 75 years old, and all genders are welcome. It is important to note that children are not eligible to participate.
Development Timeline
The journey of LY3971297 began recently, with the first clinical trial initiated on November 28, 2023. Since then, Eli Lilly and Company has been the sole sponsor driving its development. The drug is currently in its early stages, with both of its two trials being Phase 1 studies, focusing on initial safety and dosage assessments. Across these trials, a total of 315 participants are expected to contribute to the understanding of LY3971297.
Initially, researchers explored LY3971297 for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. However, the development pipeline has since broadened significantly, reflecting a growing interest in its potential across various health challenges. The scope of investigation now includes:
- Heart Failure, Diastolic
- Heart Failure, Systolic
- Hypertension
- Obesity
This expansion indicates a strategic shift towards addressing a wider range of metabolic and cardiovascular conditions, with the latest trial projected to conclude by April 23, 2026.