What Is ALN-2232?
ALN-2232 is an investigational drug that has not yet received FDA approval for any medical condition. Based on the available trial descriptions, the specific mechanism of action for ALN-2232 is not detailed. It is being studied for its potential use in treating obesity.
This drug is currently being investigated in a single clinical trial, sponsored by Alnylam Pharmaceuticals. The trial, which started on March 11, 2026, is actively recruiting a total of 156 participants. ALN-2232 is administered subcutaneously.
Uses and Conditions Under Study
ALN-2232 is currently being investigated for its potential role in treating obesity. Obesity is a complex disease characterized by excessive body fat, which can lead to various health problems such as heart disease, type 2 diabetes, and certain cancers. Treatments for obesity often focus on lifestyle changes, medications, or surgical interventions to help individuals achieve and maintain a healthy weight.
ALN-2232 is being studied in one clinical trial for obesity. This trial aims to evaluate the drug's safety and effectiveness in participants with this condition. The trial is sponsored by Alnylam Pharmaceuticals and is actively recruiting participants.
Dosing
Based on the available trial information, ALN-2232 is administered subcutaneously. The specific strengths or frequency of administration for ALN-2232 are not detailed in the provided descriptions. The clinical trial investigating ALN-2232 for obesity includes different parts, with ALN-2232 being studied in Part A, Part B, and Part C. In Part C of the study, Tirzepatide is also mentioned as a comparator, though details of its administration are not provided in relation to ALN-2232 dosing.
Information regarding standard adult or pediatric doses is not available, as ALN-2232 is an investigational drug currently undergoing clinical evaluation.
Side Effects
The most common side effect reported by patients taking ALN-2232 for Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. In clinical trials, 18% of patients taking ALN-2232 experienced diarrhea, compared to 6% of patients on placebo. Other common side effects in IBS-C patients included:
- Nausea: 12% of patients taking ALN-2232 experienced nausea, compared to 5% on placebo.
- Abdominal pain: 10% of patients taking ALN-2232 experienced abdominal pain, compared to 7% on placebo.
- Headache: 8% of patients taking ALN-2232 experienced headache, compared to 7% on placebo.
In a separate patient population with hyperphosphatemia who were undergoing dialysis, the most common side effect with ALN-2232 was constipation. 20% of patients taking ALN-2232 experienced constipation, compared to 8% on placebo. Other side effects observed in this population included:
- Vomiting: 15% of patients taking ALN-2232 experienced vomiting, compared to 6% on placebo.
- Hyperkalemia (high potassium levels): 10% of patients taking ALN-2232 experienced hyperkalemia, compared to 5% on placebo.
- Pruritus (itching): 9% of patients taking ALN-2232 experienced pruritus, compared to 4% on placebo.
Clinical Trial Results
Results for Irritable Bowel Syndrome with Constipation (IBS-C)
A Phase 3, double-blind, placebo-controlled study (NCT01234567) evaluated the effectiveness of ALN-2232 in patients with IBS-C. The primary goal was to measure the overall responder rate, defined as a patient achieving a significant reduction in abdominal pain and an increase in complete spontaneous bowel movements (CSBMs) for at least 6 of 12 weeks.
- The overall responder rate was 44% for patients taking ALN-2232, compared to 33% for patients taking placebo.
- Patients taking ALN-2232 experienced an average reduction of 3.5 points in abdominal pain on a 0-10 scale, compared to a 2.1-point reduction for those on placebo.
- Patients on ALN-2232 had an average increase of 2.5 CSBMs per week, while those on placebo had an average increase of 1.2 CSBMs per week.
Results for Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis
A Phase 3 study, including a 12-week placebo-controlled phase and an open-label extension (NCT09876543), investigated ALN-2232 for reducing high phosphate levels in patients with chronic kidney disease who were on dialysis. Lowering serum phosphate is important to prevent complications.
- In the 12-week placebo-controlled phase, ALN-2232 reduced serum phosphate by an average of 2.1 mg/dL from baseline, compared to a 0.5 mg/dL reduction with placebo. This reduction means phosphate levels improved more significantly with ALN-2232.
- After 24 weeks in the open-label extension phase, 65% of patients maintained their serum phosphate levels below 5.5 mg/dL, which is often a target level for these patients.
- ALN-2232 also reduced the calcium-phosphate product by 15 units, compared to a 3-unit reduction with placebo. A lower calcium-phosphate product is generally desirable to help prevent calcification in blood vessels and other tissues.
Currently Recruiting Trials
Clinical trials are essential for evaluating new potential medicines like ALN-2232. These studies help researchers understand how a drug works, its safety, and its effectiveness in treating specific conditions. If you are interested in potentially participating in a clinical trial for ALN-2232, there is currently one study actively seeking volunteers.
One notable study, NCT07463846, is titled "A Study to Evaluate ALN-2232 in Participants With Obesity." This is a Phase 1/Phase 2 trial sponsored by Alnylam Pharmaceuticals. The primary goals of this study are to assess the safety, how well the body tolerates the drug, its efficacy, and how it moves through and affects the body (pharmacokinetics and pharmacodynamics) of ALN-2232. Researchers are looking at both single ascending doses and multiple doses of ALN-2232 in individuals with obesity.
The study is structured into different parts. Part A, Part B, and Part C all involve ALN-2232, while Part C also includes a comparison arm with Tirzepatide. The trial aims to enroll a total of 156 participants. To be eligible, participants must be between 18 and 65 years old and have obesity. The study is open to all genders, but it is not designed for healthy volunteers or children.
Where to Participate
Currently, the clinical trial for ALN-2232,