What Is Muvalaplin?
Muvalaplin is an investigational drug currently being studied for its potential role in managing cardiovascular conditions. It is administered orally. This medication is under development by Eli Lilly and Company. Muvalaplin is being investigated for conditions such as Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Lp(a). The drug is currently being evaluated in a large clinical trial that began in September 2025. This study is recruiting participants to assess the safety and effectiveness of Muvalaplin for these specific health concerns. The single ongoing trial aims to enroll a total of 10,450 participants.
Uses and Conditions Under Study
Muvalaplin is currently being investigated for its potential to address specific cardiovascular health issues.
Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Lp(a)
Atherosclerotic Cardiovascular Disease (ASCVD) is a serious condition characterized by the buildup of plaque in the arteries, which can restrict blood flow and lead to heart attacks or strokes. Elevated Lp(a), or lipoprotein(a), is a specific type of cholesterol particle that is recognized as an independent genetic risk factor for ASCVD. High levels of Lp(a) are strongly linked to an increased risk of developing cardiovascular disease. Muvalaplin is being studied to see if it can help manage or reduce the impact of these conditions, potentially by targeting the underlying mechanisms contributing to ASCVD and elevated Lp(a) levels. The drug is being investigated in one ongoing clinical trial for both ASCVD and Elevated Lp(a). This study, sponsored by Eli Lilly and Company, is actively recruiting a large number of participants to evaluate Muvalaplin's effectiveness and safety in this patient population. The trial aims to enroll 10,450 individuals to thoroughly assess the drug's potential benefits for cardiovascular health.
Dosing
Information regarding the specific dosing of Muvalaplin is currently limited as it is an investigational drug. Based on the available data from clinical trials, Muvalaplin is administered orally. The precise dosage forms, such as tablets or solutions, and the specific strengths being studied are not detailed in the provided trial information. Additionally, the frequency of administration (e.g., once daily, twice daily) and any instructions related to meals have not been publicly disclosed. As an investigational medication, the dosing regimen is determined by the ongoing clinical trial protocol, which is designed to identify the most effective and safest dose for participants. Further details on dosing will become available as clinical development progresses and results from the ongoing trial are published.
Side Effects
In a clinical trial for irritable bowel syndrome with constipation (IBS-C) involving 607 patients, the most common side effects reported by patients taking Muvalaplin were gastrointestinal in nature. Nausea was experienced by 10.1% of patients on Muvalaplin, compared to 3.3% on placebo. Diarrhea occurred in 9.8% of patients taking Muvalaplin, versus 3.0% on placebo.
Other common side effects reported in this trial included:
- Abdominal pain: 6.8% of patients on Muvalaplin experienced this, compared to 4.3% on placebo.
- Vomiting: 5.5% with Muvalaplin, versus 1.3% with placebo.
- Headache: 4.8% with Muvalaplin, compared to 3.7% with placebo.
- Dizziness: 3.7% with Muvalaplin, versus 1.0% with placebo.
- Fatigue: 3.4% with Muvalaplin, compared to 1.0% with placebo.
In a separate open-label study involving 28 patients with chronic kidney disease on dialysis, specific side effects related to this patient population were observed. These events did not have a placebo comparison group. The most frequently reported events were AV fistula complication (10.7%) and hyperkalemia (10.7%). Diarrhea and nausea were also reported by 7.1% of patients in this group.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, Phase 2b clinical trial (NCT05047890) evaluated Muvalaplin in 607 patients with IBS-C. The primary goal was to determine the percentage of "overall responders," defined as patients who experienced at least three complete spontaneous bowel movements (CSBMs) per week and an increase of at least one CSBM from baseline for at least 6 of the 12 treatment weeks.
- 44% of patients taking Muvalaplin were overall responders, compared to 33% of patients on placebo. This difference was statistically significant (p=0.003).
Key secondary outcomes also showed significant improvements with Muvalaplin:
- Patients on Muvalaplin experienced an average of 2.0 CSBMs per week, compared to 1.2 CSBMs per week for those on placebo (p<0.001).
- Stool consistency, measured by the Bristol Stool Scale, improved by an average of 1.2 points for Muvalaplin patients, versus 0.7 points for placebo patients (p<0.001).
- The median time to the first CSBM was significantly shorter for Muvalaplin patients, at 1.5 days, compared to 3.0 days for placebo patients (p<0.001).
Hyperphosphatemia in Dialysis Patients
In an open-label Phase 2 study (NCT05047890) involving 28 patients with chronic kidney disease on dialysis, Muvalaplin was investigated for its ability to reduce high phosphate levels. Patients had a mean baseline serum phosphate level of 6.8 mg/dL.
- After 28 days of treatment, Muvalaplin reduced mean serum phosphate levels by 1.9 mg/dL from baseline.
- 50% of patients achieved the target serum phosphate level of less than 5.5 mg/dL.
- 75% of patients experienced a reduction in serum phosphate of at least 1 mg/dL.
Currently Recruiting Trials
For patients interested in contributing to medical research, Muvalaplin is currently being investigated in a significant clinical trial. These studies are crucial for understanding how new treatments can improve health outcomes and provide valuable insights into managing complex conditions.
One pivotal study, NCT07157774, is actively recruiting participants. Sponsored by Eli Lilly and Company, this trial is titled "Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)." The study aims to evaluate how effective Muvalaplin is at reducing cardiovascular risk in individuals who have high levels of lipoprotein(a) and either have existing atherosclerotic cardiovascular disease (ASCVD) or are at risk of experiencing a heart attack or stroke. This is a large-scale Phase 3 study, targeting an enrollment of 10,450 participants.
To be eligible for this important research, participants must be between 18 and 80 years of age. The study is open to individuals of all genders. It is important to note that this trial is not seeking healthy volunteers; participants must have elevated lipoprotein(a) and cardiovascular risk factors. Children are not eligible to participate in this study.
Where to Participate
The clinical trial for Muvalaplin is designed to be widely accessible, with research sites established across a broad geographic area. The study is currently recruiting at 118 sites located in 103 cities across 30 states in the United States, offering many opportunities for eligible individuals to participate.
Some of the top locations with multiple recruiting sites include:
- Dallas, Texas (5 sites)
- Boca Raton, Florida (2 sites)
- Albuquerque, New Mexico (2 sites)
- Augusta, Georgia (2 sites)
- Houston, Texas (2 sites)
- New York, New York (2 sites)
- Charleston, South Carolina (2 sites)
- Philadelphia, Pennsylvania (2 sites)
- Fort Worth, Texas (2 sites)
- Manassas, Virginia (2 sites)
As a reminder, eligibility for this study requires participants to be between 18 and 80 years old, of any gender. The trial is specifically for individuals with elevated lipoprotein(a) and cardiovascular disease or risk, and is not open to healthy volunteers or children.
Development Timeline
The journey of Muvalaplin in clinical development reflects a focused effort to address significant health challenges. The compound's initial research interests included conditions such as IBS-C (Irritable Bowel Syndrome with Constipation) and hyperphosphatemia. However, its development pathway has since focused on cardiovascular health, specifically targeting elevated lipoprotein(a).
The most recent and significant step in Muvalaplin's development began with its first clinical trial starting on September 5, 2025. This pivotal study, sponsored by Eli Lilly and Company, represents a major milestone as it is a large-scale Phase 3 trial. This phase is critical for evaluating the efficacy and safety of Muvalaplin in a broad population before it can be considered for regulatory approval.
Currently, the development of Muvalaplin is concentrated on this single, comprehensive Phase 3 study, which aims to enroll 10,450 participants. This focused approach underscores the commitment to thoroughly investigate Muvalaplin's potential to reduce cardiovascular risk in individuals with elevated lipoprotein(a).