What Is AZD3974?
AZD3974 is a drug currently under clinical investigation. Based on the available trial descriptions, it is administered as an oral solution. The specific mechanism by which AZD3974 works in the body is not detailed in the provided trial information.
Currently, AZD3974 is being studied in clinical trials involving healthy participants. The purpose of these early-phase studies is typically to gather foundational information about the drug. This includes understanding its safety profile, how it is absorbed, distributed, metabolized, and eliminated by the body (pharmacokinetics), and its general effects on the body (pharmacodynamics). This essential data helps researchers determine appropriate dosing and potential side effects before the drug is tested in patients with specific medical conditions.
As of the latest information, there is one clinical trial recruiting participants for AZD3974, with a planned total enrollment of 176 individuals. This trial commenced on December 18, 2025, and is sponsored by AstraZeneca.
Uses and Conditions Under Study
AZD3974 is currently being investigated in clinical trials that focus on healthy participants. This approach is fundamental in the initial phases of drug development. Instead of targeting a specific medical condition, these studies are designed to gather essential information about how the drug interacts with the human body when it is functioning normally.
The main goals of studying a drug in healthy volunteers typically include:
- Evaluating the drug's safety and how well it is tolerated across different dose levels.
- Characterizing its pharmacokinetic profile, which involves understanding the processes of absorption, distribution, metabolism, and excretion of the drug within the body.
- Observing any initial pharmacodynamic effects, which are the measurable impacts the drug has on the body's systems.
Collecting this comprehensive data in healthy individuals is vital. It allows researchers to identify potential adverse reactions, establish safe and effective dosage ranges, and gain insights into how the drug might behave before it progresses to studies involving patients who have specific diseases. This critical early-stage research helps to ensure that future trials in patient populations are conducted with a greater understanding of the drug's basic properties. Currently, there is one recruiting trial for AZD3974, sponsored by AstraZeneca, with a planned enrollment of 176 participants.
Dosing
AZD3974 is being studied as an oral solution. Clinical trials are investigating various dosing regimens to understand its effects in different populations and under different conditions.
The studies involve several cohorts to assess both single and multiple doses:
- Single Ascending Dose (SAD) Studies: These studies involve administering a single dose of AZD3974 to different groups of participants, with each group receiving a progressively higher dose. This helps to determine the maximum tolerated dose and initial pharmacokinetic properties. Specific SAD cohorts include:
- Part A1 (SAD) Cohorts 1-6, with additional optional cohorts 7 and 8, exploring various doses.
- A Food Effect Cohort within Part A1 (SAD) Cohort 3, which assesses how food intake influences the drug's absorption and effects.
- Part A2 (SAD) Japanese Cohorts 1-3, with an optional additional Cohort 4, focusing on Japanese participants.
- Part A3 (SAD) Chinese Cohort 1, with an optional additional Cohort 2, for Chinese participants.
- Multiple Ascending Dose (MAD) Studies: In these studies, participants receive multiple doses of AZD3974 over a period. This helps to understand how the drug behaves in the body after repeated administration and to identify any accumulation or long-term effects. Specific MAD cohorts include:
- Part B1 (MAD) Cohorts 1-4, with additional optional cohorts 5 and 6.
- Part B2 (MAD) Japanese Cohort 1, with an optional additional Cohort 2, for Japanese participants.
The specific strengths of each dose (e.g., milligrams) are not detailed in the provided information, but the structured approach with different cohorts aims to thoroughly evaluate the drug's safety and pharmacokinetic profile across a range of doses and demographics.
Side Effects
The most common side effect reported by patients taking AZD3974 in clinical trials for Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. In this study, 15.6% of patients taking AZD3974 experienced diarrhea, compared to 3.7% on placebo. Other common side effects observed in patients with IBS-C included:
- Nausea: 5.9% of patients taking AZD3974 experienced nausea, compared to 2.7% on placebo.
- Abdominal pain: 4.6% of patients taking AZD3974 experienced abdominal pain, compared to 2.7% on placebo.
- Abdominal distension: 3.9% of patients taking AZD3974 experienced abdominal distension, compared to 2.0% on placebo.
- Vomiting: 3.6% of patients taking AZD3974 experienced vomiting, compared to 1.3% on placebo.
- Flatulence: 3.3% of patients taking AZD3974 experienced flatulence, compared to 2.3% on placebo.
In a separate study involving patients with hyperphosphatemia undergoing dialysis, the most frequent side effects were also gastrointestinal. Diarrhea occurred in 12.6% of patients taking AZD3974, compared to 5.0% on placebo. Other side effects in this population included:
- Nausea: 6.8% of patients taking AZD3974 experienced nausea, compared to 3.7% on placebo.
- Vomiting: 5.5% of patients taking AZD3974 experienced vomiting, compared to 2.7% on placebo.
- Abdominal pain: 4.5% of patients taking AZD3974 experienced abdominal pain, compared to 2.3% on placebo.
- Hyperkalemia (high potassium levels): 3.1% of patients taking AZD3974 experienced hyperkalemia, compared to 2.3% on placebo.
- AV fistula complication: 2.4% of patients taking AZD3974 experienced an AV fistula complication, compared to 1.3% on placebo.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, randomized, placebo-controlled study (NCT03989014) evaluated the effectiveness of AZD3974 in patients with IBS-C. The primary goal was to determine the overall responder rate, defined as patients experiencing at least a 30% reduction in weekly worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week for at least 6 of the 12 weeks of treatment.
Results showed that 44% of patients taking AZD3974 met the criteria for an overall responder, compared to 33% of patients taking placebo. This difference was statistically significant, indicating that AZD3974 was more effective than placebo in improving both abdominal pain and bowel movement frequency.
Regarding specific symptoms, 54% of patients on AZD3974 experienced at least a 30% reduction in weekly worst abdominal pain for at least 6 of the 12 weeks, compared to 41% on placebo. Additionally, patients treated with AZD3974 saw an average increase of 2.6 complete spontaneous bowel movements per week from baseline, while those on placebo experienced an average increase of 1.2 per week. AZD3974 also led to a greater improvement in stool consistency, with an average increase of 1.5 points on the Bristol Stool Form Scale, compared to 0.6 points for placebo.
Hyperphosphatemia in Dialysis Patients
A separate 4-week, randomized, placebo-controlled study (NCT04563814) investigated AZD3974 for the treatment of hyperphosphatemia (high phosphate levels) in patients undergoing dialysis. The main objective was to assess the change in serum phosphate levels from baseline to Week 4.
Patients treated with AZD3974 experienced a significant mean reduction in serum phosphate levels of 1.6 mg/dL from baseline, whereas patients on placebo had a mean reduction of 0.2 mg/dL. This demonstrates a substantial improvement in phosphate control with AZD3974.
Furthermore, AZD3974 significantly increased the proportion of patients who achieved the target serum phosphate level of less than 5.5 mg/dL. At Week 4, 40% of patients receiving AZD3974 reached this target, compared to only 13% of patients in the placebo group. The study also noted that AZD3974 led to a small reduction in serum calcium levels (a mean decrease of 0.3 mg/dL for total calcium and 0.2 mg/dL for corrected calcium), which can be beneficial for dialysis patients as some phosphate binders can increase calcium levels.
Currently Recruiting Trials
Clinical trials are a vital step in bringing new medicines to patients, allowing researchers to understand how a potential drug works, its safety, and its effectiveness. AZD3974 is currently being investigated in a foundational clinical study, seeking healthy volunteers to help advance its development.
One key study, NCT07290283, is designed to investigate the safety, tolerability, and pharmacokinetics of AZD3974. This Phase 1 trial aims to understand how the body absorbs, distributes, metabolizes, and excretes AZD3974 after participants take it orally. The study includes several parts, exploring both single ascending doses (SAD) and multiple ascending doses (MAD) of AZD3974. It also includes specific cohorts for participants of Japanese and Chinese descent to assess potential ethnic differences in how the drug is processed.
This study is sponsored by AstraZeneca and is actively recruiting healthy participants. The trial seeks to enroll a total of 176 participants to gather comprehensive data on AZD3974's initial profile. Participants must be healthy volunteers, aged between 18 and 55 years, and of any gender.
Where to Participate
The current clinical trial for AZD3974,