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Azd9550

AZD9550 is an investigational drug currently undergoing clinical trials for the treatment of Non-alcoholic Steatohepatitis (NASH), a severe form of liver disease often associated with obesity and type 2 diabetes. These trials aim to assess the safety, tolerability, and effectiveness of AZD9550 in various patient populations, including healthy individuals and those with obesity or diabetes. The studies are designed to evaluate different dosing regimens and administration methods, providing valuable insights into the drug’s potential as a new therapeutic option for NASH.

Table of Contents

What is AZD9550?

AZD9550 is a new drug that is currently in the early stages of development. It is being studied as a potential treatment for a liver condition called Non-alcoholic Steatohepatitis (NASH)[1]. NASH is a type of liver disease that commonly affects people who are overweight or obese, and it can occur in individuals with or without Type 2 Diabetes Mellitus (T2DM)[2].

What Condition Does AZD9550 Aim to Treat?

The primary target condition for AZD9550 is Non-alcoholic Steatohepatitis (NASH). NASH is a serious liver disease characterized by inflammation and damage to liver cells. It occurs when there’s an accumulation of fat in the liver, leading to inflammation and cell damage. This condition is becoming increasingly common, especially in people who are overweight, obese, or have type 2 diabetes[2].

How Does AZD9550 Work?

While the exact mechanism of action for AZD9550 is not explicitly stated in the provided information, the drug is being studied for its effects on several important factors related to NASH and metabolic health. These include[2]:

  • Reduction in liver fat: AZD9550 is being evaluated for its ability to decrease the amount of fat in the liver, which is a key factor in NASH.
  • Impact on body weight: The drug is being studied for its potential effects on body weight and body fat percentage.
  • Effects on glucose metabolism: Researchers are looking at how AZD9550 might influence blood sugar levels, insulin, and other factors related to glucose metabolism.
  • Changes in lipid profile: The drug’s impact on various types of cholesterol and other blood fats is being examined.

Current Clinical Trials

AZD9550 is currently being studied in several clinical trials to assess its safety, how well the body tolerates it, and how it works in the body (known as pharmacokinetics and pharmacodynamics). Two main studies are currently underway[1][2]:

  1. A Phase I study (NCT05848440) is looking at single doses of AZD9550 in healthy participants. This study aims to understand the basic safety and how the drug moves through the body.
  2. A Phase I/II study (NCT06151964) is examining multiple doses of AZD9550 in overweight and obese participants, with or without type 2 diabetes. This larger study is investigating how the drug affects various aspects of metabolism and liver health over a longer period.

How is AZD9550 Administered?

Based on the clinical trial information, AZD9550 is administered in two main ways[1][2]:

  • Subcutaneous (SC) injection: This means the drug is injected just under the skin. This is the primary method being studied.
  • Intravenous (IV) injection: In some parts of the study, the drug is also being given directly into a vein.

The frequency of administration varies depending on the specific part of the study, ranging from single doses to weekly or bi-weekly injections over several weeks or months.

Safety and Potential Side Effects

As AZD9550 is still in early stages of testing, its full safety profile is not yet known. The current clinical trials are designed to carefully monitor for any side effects or safety concerns. Some of the key safety measures being assessed include[2]:

  • Adverse events (AEs) and serious adverse events (SAEs)
  • Changes in vital signs
  • Changes in ECG parameters (heart rhythm measurements)
  • Changes in laboratory test results
  • Development of antibodies against the drug

It’s important to note that all participants in these trials are closely monitored for any potential side effects or safety concerns.

Who Can Participate in AZD9550 Trials?

The current clinical trials for AZD9550 are recruiting different groups of participants[1][2]:

  • Healthy volunteers (for initial safety testing)
  • Overweight and obese individuals
  • People with or without Type 2 Diabetes
  • Adults aged 18 to 65 years
  • Both men and women (though women must be of non-childbearing potential in some studies)

Specific eligibility criteria may vary for different parts of the studies, and potential participants would need to be screened to ensure they meet all necessary requirements.

Future Prospects for AZD9550

While it’s too early to predict the long-term prospects for AZD9550, the ongoing clinical trials will provide crucial information about its potential as a treatment for NASH. If these early studies show promising results in terms of safety and effectiveness, AZD9550 may progress to larger, more advanced clinical trials[2].

The development of AZD9550 represents an important step in the search for effective treatments for NASH, a condition that currently has limited treatment options. However, it’s important to remember that drug development is a long and complex process, and it may be several years before we know whether AZD9550 could become an approved treatment for NASH.

Aspect Details
Drug Name AZD9550
Primary Indication Non-alcoholic Steatohepatitis (NASH)
Study Phases Phase I and Phase I/II
Administration Routes Subcutaneous (SC) and Intravenous (IV)
Study Populations Healthy volunteers, overweight/obese individuals, and those with Type 2 Diabetes Mellitus
Key Outcomes Measured Safety, tolerability, pharmacokinetics, pharmacodynamics, changes in liver fat, body weight, glucose metabolism, and lipid profiles
Study Designs Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), randomized, placebo-controlled
Duration of Treatment Varies by study part, ranging from single doses to 24 weeks of treatment
Imaging Techniques Used MRI-PDFF for liver fat quantification, MRS for hepatic glycogen measurement
Monitoring Methods Blood tests, Continuous Glucose Monitoring (CGM), Mixed Meal Tolerance Tests (MMTT)

FAQ

  • What is AZD9550 being studied for? AZD9550 is being studied primarily for the treatment of Non-alcoholic Steatohepatitis (NASH), a type of liver disease commonly affecting overweight and obese individuals, with or without Type 2 Diabetes Mellitus.
  • How is AZD9550 administered in the clinical trials? In the clinical trials, AZD9550 is administered through subcutaneous (SC) injections and, in some cases, intravenous (IV) injections. The dosing regimens vary, including single doses, multiple weekly doses, and doses that increase over time.
  • What are the main goals of the AZD9550 clinical trials? The main goals of the AZD9550 clinical trials are to assess its safety, tolerability, pharmacokinetics (how the drug moves through the body), and pharmacodynamics (the drug's effects on the body). The studies also aim to evaluate the drug's impact on various health markers related to NASH, such as liver fat content, body weight, and glucose metabolism.
  • Who can participate in the AZD9550 clinical trials? The clinical trials for AZD9550 include various participant groups, such as healthy individuals, overweight or obese individuals, and people with Type 2 Diabetes Mellitus. Some trials specifically focus on Japanese participants. Eligibility criteria may vary between different parts of the studies.
  • What are some of the outcomes being measured in the AZD9550 trials? The trials are measuring numerous outcomes, including changes in liver fat fraction, body weight, glucose levels, lipid profiles, and liver volume. They also assess the drug's safety through monitoring adverse events, vital signs, and laboratory parameters. Additionally, the studies evaluate the drug's effects on insulin sensitivity and the body's immune response to the medication.

Ongoing Clinical Trials on Azd9550

  • Study of AZD9550 and AZD6234 combination for weight loss in people with obesity or overweight with health complications

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Safety and Effects of AZD9550 for Overweight and Obese Patients with Non-Alcoholic Steatohepatitis (NASH) with or without Type 2 Diabetes

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany Sweden

Glossary

  • Non-alcoholic Steatohepatitis (NASH): A severe form of non-alcoholic fatty liver disease characterized by inflammation and liver cell damage, which can lead to scarring of the liver and more serious complications.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics (PD): The study of the biochemical and physiological effects of drugs on the body, including their mechanisms of action and the relationship between drug concentration and effect.
  • Subcutaneous (SC): A route of administration where a drug is injected into the layer of tissue between the skin and muscle.
  • Intravenous (IV): A route of administration where a drug is injected directly into a vein.
  • Single Ascending Dose (SAD): A study design where participants receive a single dose of the drug, with the dose increasing for each new group of participants to assess safety and tolerability.
  • Multiple Ascending Dose (MAD): A study design where participants receive multiple doses of the drug over time, with the dose increasing for each new group to assess safety, tolerability, and drug accumulation.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, causes a significant incapacity, or results in a congenital anomaly or birth defect.
  • Anti-Drug Antibodies (ADA): Antibodies produced by the immune system in response to a therapeutic drug, which can potentially affect the drug's efficacy or safety.
  • Magnetic Resonance Imaging – Proton Density Fat Fraction (MRI-PDFF): An imaging technique used to quantify the amount of fat in the liver non-invasively.
  • Continuous Glucose Monitoring (CGM): A method for tracking glucose levels throughout the day and night, providing a more complete picture of a person's glucose patterns.
  • HbA1c: A blood test that measures average blood sugar levels over the past 2-3 months, commonly used to diagnose and monitor diabetes.
  • Mixed Meal Tolerance Test (MMTT): A test used to assess how the body responds to glucose and other nutrients, typically involving consuming a standardized meal and measuring blood glucose and insulin levels over time.

References

  1. https://clinicaltrials.gov/study/NCT05848440
  2. https://clinicaltrials.gov/study/NCT06151964