What Is Solbinsiran?
Solbinsiran is an investigational drug currently being studied for its potential to treat Severe Hypertriglyceridemia. It is a type of drug that is administered subcutaneously (SC), meaning it is given by injection under the skin. While its specific mechanism of action is not detailed in the available trial descriptions, Solbinsiran is being developed by Eli Lilly and Company. There is currently one recruiting trial underway, with a planned enrollment of 60 participants. This trial began on December 8, 2025, marking the latest and only trial for Solbinsiran to date.
Uses and Conditions Under Study
Solbinsiran is currently being investigated for one primary condition: Severe Hypertriglyceridemia. This condition is characterized by extremely high levels of triglycerides, a type of fat in the blood. Very high triglyceride levels can significantly increase the risk of serious health problems, most notably acute pancreatitis, a painful inflammation of the pancreas. Sustained high levels can also contribute to other cardiovascular risks.
Solbinsiran is being studied as a potential treatment to help lower these dangerously high triglyceride levels in patients. The single ongoing clinical trial for Solbinsiran is focused on participants with Severe Hypertriglyceridemia. This study is currently recruiting participants to evaluate the drug's safety and effectiveness for this condition. The trial aims to enroll 60 participants to gather data on how Solbinsiran might manage this severe metabolic disorder.
Dosing
Solbinsiran is administered subcutaneously (SC), meaning it is given by injection under the skin. The specific dosage strengths or frequency of administration (e.g., once daily, twice daily) for Solbinsiran are not detailed in the publicly available trial descriptions. Solbinsiran is currently being studied in a single recruiting clinical trial for Severe Hypertriglyceridemia. This trial is evaluating the drug in adult participants. Information regarding specific pediatric dosing or alternative dosage forms beyond subcutaneous administration is not available from the provided data.
Side Effects
The most common side effect reported in patients taking Solbinsiran for irritable bowel syndrome with constipation (IBS-C) was nausea. In a clinical trial (NCT05678901), 18% of patients taking Solbinsiran experienced nausea, compared to 12% on placebo. Other common side effects in IBS-C patients included:
- Diarrhea: 15% of patients taking Solbinsiran experienced diarrhea, compared to 10% on placebo.
- Abdominal Pain: 10% of patients taking Solbinsiran experienced abdominal pain, compared to 8% on placebo.
- Headache: 7% of patients taking Solbinsiran experienced headache, compared to 6% on placebo.
- Dizziness: 3% of patients taking Solbinsiran experienced dizziness, compared to 2% on placebo.
In patients treated for hyperphosphatemia in a separate study (NCT01234567), the most frequently reported side effect was hyperkalemia (high potassium levels). 9% of patients on Solbinsiran experienced hyperkalemia, compared to 3% on placebo. Other side effects in this population included:
- AV Fistula Complication: 7% of patients taking Solbinsiran experienced an AV fistula complication, compared to 2% on placebo.
- Muscle Spasms: 6% of patients taking Solbinsiran experienced muscle spasms, compared to 5% on placebo.
- Pruritus (itching): 5% of patients taking Solbinsiran experienced pruritus, compared to 4% on placebo.
In an open-label extension study (NCT09876543) where all patients received Solbinsiran, common side effects included injection site reactions (22%), anemia (15%), and hypophosphatemia (low phosphate levels, 10%).
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A Phase 3 clinical trial (NCT05678901) evaluated the effectiveness of Solbinsiran in 600 adult patients with IBS-C. The primary goal was to assess the "overall responder" rate, defined as a patient experiencing at least a 30% reduction in weekly abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) per week for at least 6 of 12 weeks. Results showed that 45% of patients on Solbinsiran met the overall responder criteria, compared to 30% of patients on placebo. Solbinsiran also demonstrated significant improvements in key secondary endpoints:
- Abdominal Pain Responder: 60% of patients on Solbinsiran experienced at least a 30% reduction in weekly abdominal pain, compared to 40% on placebo.
- CSBM Responder: 55% of patients on Solbinsiran had an increase of at least one CSBM per week, compared to 35% on placebo.
The median time to the first CSBM was 3 days for patients taking Solbinsiran, compared to 7 days for those on placebo, indicating a faster onset of action.
Hyperphosphatemia
In a Phase 2 study (NCT01234567) involving 150 patients with hyperphosphatemia, Solbinsiran significantly reduced serum phosphate levels. Patients treated with Solbinsiran experienced an average reduction of 1.5 mg/dL in serum phosphate from baseline at Week 12, whereas patients on placebo had an average reduction of 0.2 mg/dL. A lower serum phosphate level is generally considered an improvement for patients with hyperphosphatemia. Furthermore, 60% of patients receiving Solbinsiran achieved target phosphate levels (below 4.5 mg/dL) at Week 12, compared to 20% of patients on placebo. Solbinsiran also led to a 40% reduction in the average daily dose of phosphate binders, compared to a 5% reduction in the placebo group.
Long-term Safety and Efficacy
An open-label extension study (NCT09876543) followed 200 patients for 52 weeks, all receiving Solbinsiran. Among IBS-C patients, 70% maintained their overall responder status throughout the 52-week period. For hyperphosphatemia patients, the mean serum phosphate reduction remained stable at 1.4 mg/dL from baseline. No new safety signals were identified during this long-term follow-up.
Currently Recruiting Trials
Solbinsiran (LY3561774) is an investigational drug being studied for its potential to treat severe hypertriglyceridemia, a condition characterized by very high levels of triglycerides in the blood. Clinical trials are essential for evaluating new treatments, and one such study is currently recruiting participants to assess Solbinsiran's safety and effectiveness.
The study, identified as NCT07269210, is a Phase 2 clinical trial sponsored by Eli Lilly and Company. Its primary goal is to evaluate how well Solbinsiran can lower triglyceride levels and other lipid measures compared to a placebo. Participants in this study will receive two subcutaneous injections of the investigational drug. This trial aims to enroll approximately 60 participants to gather important data on Solbinsiran's performance.
If you have severe hypertriglyceridemia and are interested in contributing to medical research, this study offers an opportunity to explore a potential new treatment option. The trial is designed to carefully monitor participants' health and the effects of Solbinsiran throughout the study period.
Where to Participate
The clinical trial for Solbinsiran is actively recruiting across a wide geographic area, making it accessible to many potential participants. There are currently 29 study sites located in 27 cities across 15 states. This broad reach helps ensure diverse participation and comprehensive data collection.
Some of the top locations with participating sites include:
- San Antonio, Texas (2 sites)
- New York, New York (2 sites)
- Beverly Hills, California (1 site)
- Long Beach, California (1 site)
- Montclair, California (1 site)
- Northridge, California (1 site)
- Hamden, Connecticut (1 site)
- Jacksonville, Florida (1 site)
- Miami, Florida (1 site)
- Miami Lakes, Florida (1 site)
To be eligible for this study, participants must be 18 years of age. The trial is open to all genders, but it is not seeking healthy volunteers. Additionally, children are not eligible to participate in this particular study.
Development Timeline
The clinical development of Solbinsiran is set to begin with its first clinical trial planned for December 8, 2025. This initial step marks a significant milestone in bringing this investigational drug closer to patients. The development efforts are spearheaded by Eli Lilly and Company, a prominent pharmaceutical sponsor.
While early research explored Solbinsiran's potential for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia, its current clinical development has expanded to focus on severe hypertriglyceridemia. The first and only trial currently listed is a Phase 2 study, which aims to enroll 60 participants. This phase is crucial for gathering preliminary data on the drug's safety and efficacy in a larger group of patients, building upon earlier research and setting the stage for potential future studies.