What Is AZD6793?
AZD6793 is an investigational drug currently being studied in clinical trials. It is administered orally, either as a single dose or as part of a multiple-dose regimen. The drug has been studied in combination with other medications, such as metformin and itraconazole, suggesting its potential use alongside existing treatments. AZD6793 is being developed by AstraZeneca, which has sponsored all 5 clinical trials involving this compound. Research began on December 22, 2022, with the latest trial projected to conclude on February 25, 2026. A total of 1,337 participants have been enrolled across these studies to date.
Uses and Conditions Under Study
AZD6793 is currently being investigated for its potential effects in several different conditions. The majority of studies have focused on understanding how the drug behaves in the body, rather than treating a specific illness.
- Healthy Participants: Two trials have involved healthy individuals. These studies typically aim to evaluate the drug's safety, how it is absorbed, distributed, metabolized, and excreted (pharmacokinetics), and how it interacts with other medications like itraconazole.
- Chronic Obstructive Pulmonary Disease (COPD): One trial is exploring AZD6793 in patients with COPD. This condition is a group of progressive lung diseases that block airflow and make it difficult to breathe. The specific role AZD6793 might play in managing COPD is under investigation.
- Inflammatory Diseases: One trial is dedicated to inflammatory diseases. These conditions involve the body's immune system mistakenly attacking its own tissues, leading to inflammation and damage. The potential for AZD6793 to modulate inflammatory responses is being explored.
- Type 2 Diabetes Mellitus: One trial is studying AZD6793 in individuals with Type 2 Diabetes Mellitus. This condition affects how the body processes blood sugar (glucose). In one study, AZD6793 was administered alongside metformin, a common medication for Type 2 Diabetes, to assess potential interactions or combined effects.
Dosing
AZD6793 is administered orally, primarily as an oral suspension or in other oral dosage forms. Clinical trials have explored various dosing strategies to determine the most effective and safest ways to use the drug.
Studies have included both single ascending dose (SAD) and multiple ascending dose (MAD) designs, where participants receive increasing amounts of the drug to assess safety and tolerability. Specific doses studied include Dose 1 of AZD6793, Dose 2 of AZD6793, and Dose 3 of AZD6793. These dose levels are further categorized into multiple cohorts within the SAD and MAD parts of trials.
In some studies, AZD6793 has been given as a single dose on a specific day, while in others, it has been administered as part of a regimen. For instance, in one trial, AZD6793 (referred to as Treatment A) was given with morning doses of metformin, with a 12-hour interval between metformin doses. Another study involved giving AZD6793 in combination with itraconazole on specific days. The investigational dosing regimens also include different treatment sequences and specific cohorts for conditions like COPD.
Side Effects
In a clinical trial for irritable bowel syndrome with constipation (IBS-C) (NCT03339009), the most common side effect reported was nausea. 12.6% of patients taking AZD6793 experienced nausea, compared to 3.3% on placebo. Other common side effects in patients with IBS-C included:
- Diarrhea: 11.2% of patients on AZD6793 compared to 2.7% on placebo.
- Abdominal pain: 10.2% of patients on AZD6793 compared to 5.0% on placebo.
- Vomiting: 5.5% of patients on AZD6793 compared to 1.3% on placebo.
- Headache: 4.8% of patients on AZD6793 compared to 3.3% on placebo.
- Abdominal distension: 4.1% of patients on AZD6793 compared to 1.7% on placebo.
In an open-label study involving patients with hyperphosphatemia undergoing dialysis (NCT04561081), where no placebo comparison was available, common side effects included:
- AV fistula complication: 11.1% of patients.
- Hyperkalemia: 9.1% of patients.
- Diarrhea: 8.8% of patients.
- Nausea: 7.8% of patients.
- Vomiting: 7.5% of patients.
Clinical Trial Results
Results in Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week clinical trial (NCT03339009) evaluated AZD6793 in patients with IBS-C. The primary goal was to determine the overall responder rate, defined as having at least three complete spontaneous bowel movements (CSBMs) per week and an increase of at least one CSBM from baseline for at least 6 of the 12 weeks. Results showed that 44% of patients taking AZD6793 met this criteria, compared to 33% of patients on placebo.
Key secondary outcomes also demonstrated significant improvements:
- A weekly average of at least three CSBMs for at least 6 of 12 weeks was achieved by 48% of patients on AZD6793, compared to 35% on placebo.
- An increase of at least one CSBM from baseline for at least 6 of 12 weeks was observed in 56% of patients on AZD6793, compared to 42% on placebo.
Additionally, patients treated with AZD6793 reported significant improvements in abdominal pain and bloating scores when compared to those receiving placebo.
Results in Hyperphosphatemia in Dialysis Patients
An open-label study (NCT04561081) investigated AZD6793 in patients with hyperphosphatemia who were undergoing dialysis. The primary endpoint focused on the change in serum phosphate levels. Patients experienced a mean reduction of 2.1 mg/dL in serum phosphate from baseline to week 12. This means average phosphate levels decreased from 7.2 mg/dL at the start of the study to 5.1 mg/dL by week 12, indicating an improvement in phosphate control.
A key secondary outcome measured the proportion of patients who achieved target phosphate levels, defined as less than 5.5 mg/dL. By week 12, 68% of patients treated with AZD6793 reached these target phosphate levels. The study also noted that these reductions in phosphate levels were sustained through week 24 in an extension phase, suggesting a lasting effect.
Currently Recruiting Trials
AZD6793 is currently being investigated in clinical trials to understand its potential benefits for various health conditions. These studies are crucial steps in determining if a new medication is safe and effective for patient use. If you are interested in potentially participating in a clinical trial, you can learn more about the specific studies below.
One active study, NCT07082738, is a Phase IIb dose-ranging trial sponsored by AstraZeneca. This study aims to evaluate the efficacy and safety of AZD6793 in individuals living with Chronic Obstructive Pulmonary Disease (COPD). Specifically, researchers are comparing three different doses of AZD6793 against a placebo to see how well the medication works and if it is well-tolerated by participants. The trial is designed to enroll approximately 1160 participants who have moderate to very severe COPD. By studying different dosages, researchers hope to identify the most effective and safest treatment approach for this condition.
Where to Participate
The clinical trial for AZD6793,