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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment called AZD9550 for individuals who are overweight or obese, with or without Type 2 Diabetes Mellitus. The study also includes participants with a liver condition known as Non-alcoholic Steatohepatitis (NASH). The treatment involves a solution for injection, which is administered under the skin. A placebo, which looks like the treatment but does not contain the active substance, is also used for comparison.

The purpose of the study is to evaluate the safety and tolerability of AZD9550 when given in different doses over a period of time. Participants will receive either the treatment or a placebo, and the study will monitor how the body processes the drug and its effects on the participants' health. The study will be conducted in several parts, with each part focusing on different aspects of the treatment, such as its safety and how well it is tolerated by the body.

Throughout the study, participants will undergo regular health checks, including blood tests and other assessments, to ensure their safety and to gather information on how the treatment affects their condition. The study aims to provide valuable insights into the potential benefits and risks of AZD9550 for managing weight and related health conditions. Participants will be closely monitored by healthcare professionals to ensure their well-being during the trial.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to evaluate eligibility. This includes a review of medical history and a physical examination.
Blood tests are performed to measure glucose levels, insulin, and other relevant markers.
Step 2
Randomization and baseline measurements
Participants are randomly assigned to receive either the AZD9550 or a placebo. This process is single-blind, meaning participants do not know which treatment they receive.
Baseline measurements are taken, including body weight, body fat percentage, and blood tests for cholesterol and glucose levels.
Step 3
Treatment phase part a
Participants receive weekly subcutaneous injections of AZD9550 or placebo for four weeks.
Regular monitoring of vital signs and laboratory tests is conducted to assess safety and tolerability.
Step 4
Evaluation part a
After four weeks, changes in fasting glucose, insulin, and body weight are evaluated.
Participants undergo additional blood tests to measure cholesterol levels and other markers.
Step 5
Treatment phase part b
Participants continue with multiple ascending doses of AZD9550 or placebo for an additional five weeks.
Monitoring continues with regular assessments of vital signs and laboratory tests.
Step 6
Evaluation part b
At the end of five weeks, changes in body weight, glucose levels, and liver fat are assessed using imaging techniques.
Further blood tests are conducted to evaluate changes in cholesterol and other markers.
Step 7
Treatment phase part c
Participants receive the maximum tolerated dose of AZD9550 or placebo for up to 24 weeks.
Weekly subcutaneous injections are self-administered, and regular monitoring continues.
Step 8
Final evaluation
After 24 weeks, a comprehensive evaluation is conducted, including changes in body weight, glucose levels, and liver fat.
Final blood tests and imaging studies are performed to assess the overall impact of the treatment.

Who can join the trial?

9 criteria

Participants must be males or females who cannot have children, aged between 18 and 65 years at the time of screening.
Participants can have Type 2 Diabetes Mellitus (**T2DM**) or not. If they have T2DM, their blood sugar should be controlled with a diabetes diet and metformin, plus no more than two other treatments, with stable doses for 3 months before screening.
Participants with T2DM should have a blood test result called **HbA1c** between 6% and 9%. Those without T2DM should have an HbA1c of less than 6.5%.
Participants should have a **Body Mass Index (BMI)** between 27 and 39.9 kg/m².
Participants must use birth control methods that follow local rules for clinical studies.
Participants must provide written consent and any other required permissions before any study-related procedures, including screening tests.
Participants must be able to meet all study requirements within 60 days after signing the consent form.
Participants must have suitable veins for multiple blood draws.
Participants must be willing and able to give themselves weekly injections under the skin for Parts C and D of the study.

Who cannot join the trial?

10 criteria

Patients with other liver diseases besides Non-alcoholic steatohepatitis (NASH) cannot participate. NASH is a liver condition where fat builds up in the liver, not caused by alcohol.
Patients who have had a recent heart attack or stroke are excluded.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with severe kidney problems are not eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial within the last 30 days are excluded.
Patients with a history of drug or alcohol abuse in the past year cannot join.
Patients with certain types of cancer are not eligible.
Patients with a known allergy to the study medication or similar drugs cannot participate.
Patients who are unable to comply with the study procedures are excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Medical University Of Graz
Graz, Austria
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Medical University Of Vienna
Vienna, Austria

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Investigated drugs

AZD9550 is a medication being studied for its safety and how well it is tolerated in people who are overweight or obese, with or without type 2 diabetes. The study is looking at how the body processes the medication when given in repeated doses under the skin. The goal is to find out how safe it is and how the body reacts to different amounts of the medication over time.

What is already known about the treatment

AZD9550 – This medication is administered through subcutaneous injections, meaning it is injected under the skin. Currently, AZD9550 is being studied in clinical trials and is not yet widely available in medical practice. It is primarily being investigated for its potential to treat non-alcoholic steatohepatitis (NASH), a liver condition often associated with obesity and type 2 diabetes. The drug works by targeting specific pathways in the body to reduce liver inflammation and fat accumulation, although the exact molecular mechanism is still under investigation. AZD9550 falls under the pharmacological classification of investigational drugs, as it is still undergoing research to determine its safety and effectiveness.

Investigated diseases

Non-alcoholic steatohepatitis (NASH) – This disease is a liver condition characterized by the accumulation of fat in the liver, inflammation, and liver cell damage. It is part of a group of conditions known as non-alcoholic fatty liver disease (NAFLD). NASH can progress silently, often without symptoms, but over time it may lead to liver fibrosis or scarring. As the disease advances, it can result in cirrhosis, where the liver becomes severely scarred and its function is impaired. The exact cause of NASH is not fully understood, but it is often associated with obesity, insulin resistance, and metabolic syndrome. Lifestyle factors such as diet and physical activity can influence its progression.