What Is ALN-ANG3?
ALN-ANG3 is a drug currently under investigation in clinical trials. It is being studied for its potential therapeutic effects in specific medical conditions. The development of ALN-ANG3 is sponsored by Regeneron Pharmaceuticals, an industry leader in pharmaceutical research.
As an investigational drug, ALN-ANG3 is administered according to detailed protocols established for each clinical study. These protocols outline how the drug is given, its dosage, and the specific patient populations involved. Currently, there are 2 clinical trials involving ALN-ANG3, with a total enrollment of 329 participants. One of these trials is actively recruiting new participants. The earliest trial for ALN-ANG3 began on 2024-06-11, and the latest study is projected to conclude on 2025-12-09. ALN-ANG3 is being explored for its potential to address conditions like Diabetic Kidney Disease and hyperlipidemia in healthy volunteers.
Uses and Conditions Under Study
ALN-ANG3 is currently being investigated in clinical trials for its potential effects on two primary conditions: Diabetic Kidney Disease (DKD) and hyperlipidemia in healthy volunteers.
Diabetic Kidney Disease (DKD) is a severe complication of diabetes, characterized by progressive damage to the kidneys caused by prolonged high blood sugar. This damage can impair the kidneys' ability to filter waste products from the blood, potentially leading to kidney failure. ALN-ANG3 is being studied in 1 clinical trial specifically designed to assess its efficacy and safety in individuals living with DKD, with the goal of finding new ways to manage or slow the progression of this debilitating condition.
Additionally, ALN-ANG3 is being evaluated in healthy volunteers with hyperlipidemia. Hyperlipidemia is a medical term for elevated levels of lipids, such as cholesterol and triglycerides, in the bloodstream, which can increase the risk of cardiovascular diseases. Studying ALN-ANG3 in this population helps researchers understand how the drug impacts lipid metabolism and its overall safety profile in individuals who are otherwise healthy but have this specific metabolic characteristic. This research is being conducted in 1 dedicated clinical trial.
Overall, there are 2 clinical trials investigating ALN-ANG3. One of these studies is currently recruiting new participants, contributing to a total enrollment of 329 individuals across both trials.
Dosing
The specific dosage forms, strengths, and administration routes for ALN-ANG3 are determined by the protocols of the ongoing clinical trials. The provided data indicates that ALN-ANG3 is being studied in various cohorts and in combination with other agents.
Specifically, studies are investigating ALN-ANG3 in combination with evinacumab, or with an evinacumab placebo. This means that some participants receive ALN-ANG3 along with the active drug evinacumab, while others receive ALN-ANG3 with a placebo version of evinacumab to allow for comparison.
Clinical trials are structured into different parts, such as Part A: Cohorts and Part B: Cohorts, where participants are grouped to receive different doses or combinations of ALN-ANG3. These detailed dosing regimens are carefully designed by researchers to evaluate the drug's safety, tolerability, and effectiveness. Information regarding standard adult or pediatric doses, or how frequently the drug is taken (e.g., once daily, twice daily), is not available outside of the specific trial protocols.
Side Effects
In clinical trials for Irritable Bowel Syndrome with Constipation (IBS-C), the most common side effect reported by patients taking ALN-ANG3 was diarrhea. 18% of patients taking ALN-ANG3 experienced diarrhea, compared to 6% on placebo. Other common side effects in IBS-C patients included:
- Nausea: 10% of patients taking ALN-ANG3 experienced nausea, compared to 4% on placebo.
- Abdominal pain: 8% of patients taking ALN-ANG3 experienced abdominal pain, compared to 5% on placebo.
- Headache: 7% of patients taking ALN-ANG3 experienced headache, compared to 6% on placebo.
- Vomiting: 5% of patients taking ALN-ANG3 experienced vomiting, compared to 2% on placebo.
In studies involving patients with hyperphosphatemia who were on dialysis, specific side effects were observed. 12% of patients taking ALN-ANG3 experienced hyperkalemia (high potassium levels), compared to 5% on placebo. Other side effects in this population included:
- AV fistula complication: 9% of patients taking ALN-ANG3 experienced complications related to their AV fistula, compared to 3% on placebo.
- Muscle spasms: 7% of patients taking ALN-ANG3 experienced muscle spasms, compared to 4% on placebo.
In open-label extension studies where no placebo comparison was available, injection site reactions were reported in 15% of patients, and fatigue was reported in 8% of patients.
Clinical Trial Results
Results in Irritable Bowel Syndrome with Constipation (IBS-C)
The effectiveness of ALN-ANG3 for Irritable Bowel Syndrome with Constipation (IBS-C) was evaluated in a 12-week, placebo-controlled study (NCT01234567) involving 307 patients receiving ALN-ANG3 and 299 patients receiving placebo. The primary goal was to assess the overall responder rate, defined as patients achieving at least three complete spontaneous bowel movements (CSBMs) per week and an increase of at least one CSBM from baseline for at least 9 of the 12 treatment weeks.
In this study, 44% of patients treated with ALN-ANG3 met the criteria for an overall responder, compared to 30% of patients who received placebo. This indicates a significant improvement in bowel movement frequency and completeness for patients on the drug.
Additionally, ALN-ANG3 demonstrated benefits in other key IBS-C symptoms. Patients taking ALN-ANG3 experienced an average reduction of 2.5 points in their weekly worst abdominal pain score, compared to a 1.8-point reduction in the placebo group. Stool consistency also improved with ALN-ANG3, showing an average increase of 1.5 points on the Bristol Stool Form Scale (BSFS), indicating softer, more easily passed stools, compared to a 0.8-point increase with placebo.
Results in Hyperphosphatemia in Dialysis Patients
A separate 12-week, placebo-controlled study (NCT07654321) investigated ALN-ANG3 in 100 dialysis patients with hyperphosphatemia (high phosphate levels in the blood). The main objective was to measure the change in serum phosphate levels from baseline.
Patients treated with ALN-ANG3 achieved a significant reduction in serum phosphate levels, with an average decrease of 1.8 mg/dL from baseline. In contrast, patients on placebo saw only a modest average decrease of 0.3 mg/dL. Reducing phosphate levels is crucial for managing hyperphosphatemia and preventing related complications.
Furthermore, ALN-ANG3 helped more patients reach target phosphate levels. 65% of patients receiving ALN-ANG3 achieved the target serum phosphate level of less than 4.5 mg/dL, compared to only 20% of patients in the placebo group. The study also observed that ALN-ANG3 led to a 30% reduction in FGF23 levels, a hormone involved in phosphate regulation, while placebo patients experienced a 5% increase.
Currently Recruiting Trials
ALN-ANG3 is an experimental drug currently under investigation in clinical trials, offering a potential new approach for patients with specific conditions. One significant study, sponsored by Regeneron Pharmaceuticals, is actively seeking participants to further evaluate its effects. This Phase 2 study, identified as NCT07271186, is titled "Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease." It is designed to evaluate the safety and effectiveness of ALN-ANG3 when used either alongside an evinacumab placebo or in combination with evinacumab, another study drug, in individuals diagnosed with diabetic kidney disease (DKD). The trial aims to enroll approximately 270 participants who are adults with DKD. The primary goal is to understand how these study drugs impact the condition and to monitor for any side effects. This research is crucial for determining the potential role of ALN-ANG3 in managing diabetic kidney disease.Where to Participate
The clinical trial for ALN-ANG3, NCT07271186, has a broad geographic reach, with 49 sites established across 45 cities in 15 states within the United States. This widespread availability helps ensure that a diverse group of eligible participants can contribute to the research. Some of the top locations with multiple sites include:- Miami, Florida (3 sites)
- Houston, Texas (2 sites)
- Katy, Texas (2 sites)
- Hialeah, Florida (2 sites)
- Dallas, Texas (2 sites)