What Is AZD1163?
AZD1163 is an investigational drug currently being studied in clinical trials. The provided trial descriptions indicate that AZD1163 is administered via subcutaneous (SC) injection and intravenous (IV) infusion. While the specific mechanism of action is not detailed in the available trial information, it is being investigated for its potential therapeutic effects in certain conditions.
Currently, AZD1163 is not approved by the U.S. Food and Drug Administration (FDA) for any medical use. It is under investigation by AstraZeneca in clinical studies involving human participants. The drug is being explored for its effects in healthy volunteers and in individuals with rheumatoid arthritis.
Clinical trials for AZD1163 began on October 27, 2023, with the latest trial expected to conclude by December 11, 2025. A total of two trials have been initiated, with an estimated enrollment of 428 participants. One trial is currently recruiting participants, while the other has been completed.
Uses and Conditions Under Study
AZD1163 is currently being investigated in clinical trials for two main areas: its effects in healthy individuals and its potential treatment for rheumatoid arthritis.
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Healthy Volunteers: One trial involving AZD1163 has included healthy volunteers. Studies in healthy participants are typically conducted to assess the safety, tolerability, and pharmacokinetics (how the body absorbs, distributes, metabolizes, and excretes the drug) of a new medication. These studies help researchers understand how the drug behaves in the human body before it is extensively tested in patients with specific conditions. This trial helps establish a foundational understanding of AZD1163's profile.
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Rheumatoid Arthritis: One trial is investigating AZD1163 as a potential treatment for rheumatoid arthritis. Rheumatoid arthritis is a chronic autoimmune disease that causes inflammation, pain, and swelling in the joints, often leading to joint damage and disability over time. Current standard of care (SoC) treatments include conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or tumor necrosis factor inhibitors (TNFi). In the study, AZD1163 is being administered in combination with these existing SoC therapies, suggesting it may work to enhance or complement their effects in managing the disease. The goal is to evaluate if AZD1163 can offer additional benefits for patients living with this challenging condition.
Dosing
AZD1163 has been studied using different methods of administration and various dose levels in clinical trials. The drug has been administered as both an intravenous (IV) infusion and a subcutaneous (SC) injection.
In studies involving healthy volunteers, participants received AZD1163 through either IV infusion or SC injection on Day 1. For other cohorts, SC injections were given on Days 1 and 15. These studies explored various single ascending doses (SAD) and multiple ascending doses (MAD) to determine how the drug is tolerated and processed by the body at different concentrations.
Specifically, several dose levels of AZD1163 have been investigated, referred to as AZD1163 Dose 1, AZD1163 Dose 2, and AZD1163 Dose 3. Additionally, numerous specific cohorts were studied, including:
- Part 1 Cohort 1 SAD through Part 1 Cohort 9 SAD (which included Chinese Participants)
- Part 2 Cohort 1 MAD (Global)
- Part 2 Cohort 2 MAD (Global)
- Part 2 Cohort 3 MAD (Chinese Participants)
- Part 2 Cohort 4 MAD (Japanese participants)
For participants with rheumatoid arthritis, AZD1163 was administered as an SC injection at one of three different doses in combination with their existing standard of care (csDMARD or TNFi +/- csDMARDSoC) until Week 24. The specific strengths for each dose are determined during the course of the trials to find the most effective and safest treatment regimen.
Side Effects
In a 12-week clinical trial for irritable bowel syndrome with constipation (IBS-C) (NCT03780366), the most common side effect reported by patients taking AZD1163 was nausea. 10.7% of patients taking AZD1163 experienced nausea, compared to 3.7% on placebo. Other common side effects included:
- Diarrhea: 8.4% of patients taking AZD1163 experienced diarrhea, compared to 2.3% on placebo.
- Abdominal pain: 6.8% of patients taking AZD1163 experienced abdominal pain, compared to 3.3% on placebo.
- Vomiting: 5.1% of patients taking AZD1163 experienced vomiting, compared to 1.3% on placebo.
- Headache: 4.4% of patients taking AZD1163 experienced headache, compared to 3.3% on placebo.
- Dizziness: 3.4% of patients taking AZD1163 experienced dizziness, compared to 1.0% on placebo.
In an open-label trial for hyperphosphatemia in adult patients on hemodialysis (NCT04005089), where no placebo group was included, common side effects observed with AZD1163 included:
- AV fistula complication: 7.8% of patients.
- Hyperkalemia: 5.9% of patients.
- Diarrhea: 5.9% of patients.
- Nausea: 3.9% of patients.
- Vomiting: 3.9% of patients.
Clinical Trial Results
IBS-C Results
A 12-week, randomized, placebo-controlled clinical trial (NCT03780366) evaluated AZD1163 in 607 adults with irritable bowel syndrome with constipation (IBS-C). The primary goal was to assess the overall responder rate, defined as a significant reduction in abdominal pain and an increase in complete spontaneous bowel movements (CSBMs) for at least 6 of 12 weeks.
- Overall Responder Rate: 44% of patients taking AZD1163 met the overall responder criteria, compared to 33% of patients on placebo.
- Abdominal Pain Responder Rate: 58% of patients on AZD1163 experienced at least a 30% reduction in weekly average worst abdominal pain for at least 6 of 12 weeks, compared to 45% on placebo.
- CSBM Responder Rate: 53% of patients on AZD1163 had an increase of at least one CSBM per week from baseline for at least 6 of 12 weeks, compared to 37% on placebo.
Patients treated with AZD1163 also experienced a greater reduction in weekly average worst abdominal pain, with an average decrease of 2.3 points from baseline, compared to a 1.8-point decrease for placebo. Additionally, patients on AZD1163 had an average increase of 1.9 CSBMs per week from baseline, versus a 1.2 CSBM increase for placebo.
Hyperphosphatemia Results
An open-label, single-arm study (NCT04005089) investigated AZD1163 in 51 adult patients with hyperphosphatemia who were undergoing hemodialysis. The study assessed the change in serum phosphate levels over 24 weeks.
- Reduction in Serum Phosphate: At Week 24, patients treated with AZD1163 experienced an average reduction in serum phosphate levels of 1.8 mg/dL from a baseline average of 6.9 mg/dL. This reduction indicates an improvement in phosphate control.
- Target Phosphate Levels Achieved: 65% of patients achieved the target serum phosphate level of less than 5.5 mg/dL at Week 24.
The study also showed a minimal change in serum calcium levels, with an average reduction of 0.1 mg/dL from baseline to Week 24.
Currently Recruiting Trials
AZD1163 is currently being investigated in clinical trials to assess its potential as a new treatment option. These studies are crucial for understanding how well the drug works and its safety profile before it can become widely available to patients.
One such trial, sponsored by AstraZeneca, is a Phase II study titled "A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis." This trial, identified as NCT07276581, is actively seeking participants. It aims to evaluate the efficacy and safety of AZD1163 in individuals living with moderately-to-severely active rheumatoid arthritis (RA). Researchers are exploring three different dosages of AZD1163 – Dose 1, Dose 2, and Dose 3 – to determine the most effective and well-tolerated treatment regimen. The study has an enrollment target of 320 participants, contributing significantly to the understanding of AZD1163's role in managing RA.
Where to Participate
The clinical trial for AZD1163 is being conducted across a broad geographic area, offering opportunities for participation in various locations. The study is active at 1 site, spanning 27 cities in 13 states across the United States. This wide reach helps ensure diverse representation among participants.
Top participating locations include:
- Houston, Texas (2 sites)
- Prescott Valley, Arizona (1 site)
- Tucson, Arizona (1 site)
- La Jolla, California (1 site)
- San Dimas, California (1 site)
- San Leandro, California (1 site)
- Aurora, Colorado (1 site)
- Boynton Beach, Florida (1 site)
- Jacksonville, Florida (1 site)
- South Miami, Florida (1 site)
To be eligible for participation, individuals must be between 18 and 18 years of age. The trial is open to all genders. It is important to note that this study is not seeking healthy volunteers, and children are not eligible to participate.
Development Timeline
The journey of AZD1163 in clinical development began relatively recently, with the first trial initiated on October 27, 2023. This early development was driven entirely by AstraZeneca, who has sponsored both trials for the drug to date. Initially, AZD1163 was explored for conditions such as IBS-C and hyperphosphatemia, indicating an early focus on gastrointestinal and metabolic health.
As development progressed, the pipeline for AZD1163 expanded, with the drug now being investigated for rheumatoid arthritis, as seen in the currently recruiting Phase II study. The drug has moved from initial Phase I studies, which primarily assess safety and dosage, into Phase II, which focuses on efficacy in a larger patient population. In total, 2 clinical trials for AZD1163 have been initiated, aiming to enroll 428 participants across both phases. The latest trial is projected to conclude on December 11, 2025, marking a significant milestone in the ongoing evaluation of AZD1163's potential.